Shared decision making in endocrinology: present and future directions

Personal View

Shared decision making in endocrinology: present and future directions Rene Rodriguez-Gutierrez, Michael R Gionfriddo, Naykky Singh Ospina, Spyridoula Maraka, Shrikant Tamhane, Victor M Montori, Juan P Brito

In medicine and endocrinology, there are few clinical circumstances in which clinicians can accurately predict what is best for their patients. As a result, patients and clinicians frequently have to make decisions about which there is uncertainty. Uncertainty results from limitations in the research evidence, unclear patient preferences, or an inability to predict how treatments will fit into patients’ daily lives. The work that patients and clinicians do together to address the patient’s situation and engage in a deliberative dialogue about reasonable treatment options is often called shared decision making. Decision aids are evidence-based tools that facilitate this process. Shared decision making is a patient-centred approach in which clinicians share information about the benefits, harms, and burden of different reasonable diagnostic and treatment options, and patients explain what matters to them in view of their particular values, preferences, and personal context. Beyond the ethical argument in support of this approach, decision aids have been shown to improve patients’ knowledge about the available options, accuracy of risk estimates, and decisional comfort. Decision aids also promote patient participation in the decision-making process. Despite accumulating evidence from clinical trials, policy support, and expert recommendations in endocrinology practice guidelines, shared decision making is still not routinely implemented in endocrine practice. Additional work is needed to enrich the number of available tools and to implement them in practice workflows. Also, although the evidence from randomised controlled trials favours the use of this shared decision making in other settings, populations, and illnesses, the effect of this approach has been studied in a few endocrine disorders. Future pragmatic trials are needed to explore the effect and feasibility of shared decision making implementation into routine endocrinology and primary care practice. With the available evidence, however, endocrinologists can now start to practice shared decision making, partner with their patients, and use their expertise to formulate treatment plans that reflect patient preferences and are more likely to fit into the context of patients’ lives. In this Personal View, we describe shared decision making, the evidence behind the approach, and why and how both endocrinologists and their patients could benefit from this approach.

Introduction

What is shared decision making?

Patients with endocrine disorders face situations, such as diagnostic or treatment dilemmas, in which their clinicians cannot confidently offer a best option.1,2 These situations arise when the available evidence about the relative merits of the available options fails to identify, with certainty, a clearly superior option (eg, what is the best definitive treatment for Graves’ disease, what is the first-line treatment for painful diabetic neuropathy) or when one clear best option is evident, but how well it will fit within the patient’s specific circumstances is unclear (panel 1).3 These common clinical scenarios are opportunities to involve patients in the decision making process and ensure that each patient’s situation is addressed in a manner that is effective, consistent with patient preferences, and can be implemented into their daily lives.3,4 Shared decision making is an approach in which patients and clinicians work together to consider the available options and identify one that will best address the patient’s situation.5,6 Despite evidence from trials and policy recommendations that advocate for shared decision making, this approach is still not incorporated into routine clinical practice.7–11 Here we describe shared decision making in detail and explain why endocrinologists and patients with endocrine disorders could benefit from this approach.

Shared decision making is an approach to medical decision making in which patients and clinicians work together and engage in a deliberative dialogue about reasonable treatment options (table 1).3,5,6 Each party is respected as an expert: clinicians are experts in disease and the clinical evidence, and patients are experts in their illness (the disease as experienced), their lives (ie, personal context), and what is best for them and their families (ie, values).5,6 This process of a deliberative dialogue between experts is a manifestation of evidencebased medicine in practice; the recognition that clinical evidence alone is not enough to make a decision.12 Shared decision making supports a patient-centred practice, one of the six quality domains established by the Institute of Medicine13 and responds to an ethical imperative to engage patients in decisions about their own care, thus promoting the principle of autonomy by ensuring patients are informed about their health choices.14

Lancet Diabetes Endocrinol 2016 Published Online February 22, 2016 http://dx.doi.org/10.1016/ S2213-8587(15)00468-4 Knowledge and Evaluation Research Unit, Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Medicine, Mayo Clinic, Rochester, MN, USA (R Rodriguez-Gutierrez MD, M R Gionfriddo PharmD, N Singh Ospina MD, S Maraka MD, S Tamhane MD, V M Montori, J P Brito MD); Division of Endocrinology, University Hospital “Dr. Jose E. Gonzalez”, Autonomous University of Nuevo Leon, Monterrey, Mexico (R Rodriguez-Gutierrez); and Mayo Graduate School, Mayo Clinic, Rochester, MN, USA (M G Gionfroddo PharmD) Correspondence to: Dr Juan P Brito, Knowledge and Evaluation Research Unit, Division of Endocrinology, Diabetes, Metabolism and Nutrition, Mayo Clinic, Rochester, MN 55905, USA [email protected]

Decision aids and how they support and facilitate shared decision making Decision aids are evidence-based tools—such as videos, worksheets, interactive cards, or web applications—that facilitate and support shared decision making15 and are designed to help patients and clinicians start from a common evidence-based ground. This common ground is established with a fair, complete, and balanced

www.thelancet.com/diabetes-endocrinology Published online February 22, 2016 http://dx.doi.org/10.1016/S2213-8587(15)00468-4

1

Personal View

Panel 1: When is shared decision making appropriate? Circumstances amenable to shared decision making: Difference between benefits, potential harms, inconveniences, and cost of one or more medically reasonable courses of action is trivial or unclear (eg, first-line medical therapy for obesity). Circumstances in which the distribution of patient preferences is large and clinicians cannot deduce patient preferences (eg, selection of antihyperglycaemic medication in type 2 diabetes). When one clear best option is evident, but it is unclear how well it will fit within the patient’s specific circumstances (eg, antiplatelet agents in secondary cardiovascular prevention). Circumstances not amenable to shared decision making: Only one medically reasonable course of action exists for which clinicians can correctly deduce patient preferences. This is often the case when the pros and cons of alternative courses of action are well known, their likelihood estimates are based on highly reliable research evidence, the treatments offer large effects, and the difference in benefits and harms, inconveniences, and cost between treatment forms is clear (eg, thyroid hormone therapy in myxedematous coma or glucocorticoids in pituitary apoplexy).

Meaning

Objective

Justify

Recognise that with what the best current evidence shows there is no clear best choice for a particular decision

Create a conversation and partnership

Share information (both ways)

Inform the patient of the available options and the benefits and harms of each of them; listen to the patients’ context and opinion about the options and evidence

Two-way exchange of high quality information

Elicit values and preferences (both ways)

Listen and elicit patients’ preferences about treatment and outcomes, goals, concerns, and priorities

Understand what the patient, given the circumstances, values the most

Shared decision talk

Reach a decision after integrating all the information Reach a decision that fits the (including no treatment or deferral of the decision as unique patients’ values, preferences and context a possibility)

Table 1: Core components of shared decision making

presentation of the evidence about the relative merits of available options (for example, figure 1). More sophisticated decision aids also support the process of deliberation between patients and clinicians, especially when decision aids are used during the clinical encounter as opposed to before or after the patient meets with the clinician. The high prevalence of low literacy and low numeracy, the latter affecting both patients and clinicians, calls for decision aids to be based on state-ofthe-art risk communication techniques and simple language to achieve their goal, for instance by use of pictographs (icon arrays) to communicate risks (panel 2, figure 2).16 The effectiveness of decision aids has been assessed in a Cochrane review10 of 115 studies with almost 35 000 patients. Compared to patients who received usual care, patients using decision aids were found to: feel more informed and have a better idea of what matters most to them; improve their knowledge of their options; 2

participate more in decision making; and have more accurate expectations of possible benefits and harms of their options. The effect of decision aids on adherence, choice of less invasive procedures than those given with standard care, and cost reduction remains inconclusive.10 In another systematic review,17 decision aids and other interventions used to support patient’s engagement in shared decision making were found to significantly improve the following outcomes, not only in patients with high literacy or socioeconomic status, but also among disadvantaged groups: increased knowledge, informed choice, participation in decision making, decision self-efficacy, preference for collaborative decision making, and reduced decisional conflict. The narrative analysis of the review17 suggests that interventions based on shared decision making might be more beneficial to disadvantaged groups than to patients with higher literacy or socioeconomic status. In view of the current evidence, several legislative efforts exist to promote decision aids and shared decision making, including provisions included in the 2009 The Patient Protection and Affordable Care Act (Pub. L No. 11-148).18

Endocrinology and shared decision making: a recipe for patient-centred care A few medical decisions have a clear best answer in which the distribution of patient preferences is narrow and clinicians are able to correctly deduce the preferences of a particular patient. The estimates used for these decisions are based on highly reliable research evidence. In endocrinology, there are few of these decisions (eg, steroids for adrenal insufficiency and insulin for diabetic ketoacidosis) and they are often based on all-or-nothing evidence (ie, very large treatment effects).12 60% of the recommendations in all current endocrine clinical practice guidelines are supported by low or very low quality evidence, and only one in ten recommendations, at best, are based on evidence warranting high confidence in the estimates.1,2 Unfortunately, this situation will probably not change because research that could improve trust in estimates of effect is ongoing for only one in five recommendations that are based on very low quality evidence.19 Consequently, decisions that are made in daily practice for patients with endocrine disorders are not linked to research that gives high confidence that patients who follow recommendations will be in a more favourable situation.20–35 Thus, clinical practice guidelines in these situations suggest recommendations based on low quality evidence where more than one course of action can be taken (table 2).22,24,26,28,29,31,33,35,38,40,41,44,45,47 Shared decision making is particularly important when the available evidence does not allow the clinician to give clear answers about a decision but rather supports a dialogue about the pros and cons of the different options and the substantial uncertainty surrounding the decisions.4 The same is true for some technical decisions that are based on high quality evidence, for which shared

www.thelancet.com/diabetes-endocrinology Published online February 22, 2016 http://dx.doi.org/10.1016/S2213-8587(15)00468-4

Personal View

Copyright: Mayo Foundation for Research and Education

Figure 1: Diabetes Medication Choice decision aid The Diabetes Medication Choice decision aid is useful when a decision about starting a diabetes medication has to be made. The tool helps patients and clinicians have meaningful conversations about the benefits (HbA1c reduction), harms (hypoglycaemia, weight gain, other side effects), convenience (daily routine), and cost of each of the available alternatives. Produced with permission by the Mayo Foundation for Research and Education.

decision making could also help patients consider how the options will fit into their daily routines and how they will implement their decision within those routines (eg, blood sugar self-monitoring and adherence to statin therapy for patients with type 2 diabetes).3,6 In addition to the complexities and knowledge gaps in the evidence that supports the need for shared decision making, patient complexities create an even more

compelling case for this approach in endocrinology.3–5 Many patients seen in endocrinology and primary care have multiple morbidities. Hence, even when high quality evidence to support a particular recommendation exists, straightforward decisions about the addition of a new treatment or intervention can become challenging for a patient who is affected by the management of their multimorbidity. Consequently, each treatment option not

www.thelancet.com/diabetes-endocrinology Published online February 22, 2016 http://dx.doi.org/10.1016/S2213-8587(15)00468-4

3

Personal View

Panel 2: Example case A 70-year-old retired construction worker presents with type 2 diabetes, obesity, dyslipidaemia, and hypertension. Mr Jones is adherent to lifestyle interventions and a maximum metformin dose (2 g/day). He does not smoke, his blood pressure is well controlled on an angiotensin-converting enzyme inhibitor, and he takes a statin for primary prevention of cardiovascular disease. 3 months ago, he met with a dietitian to discuss lifestyle changes that could help him lose weight and control his diabetes. Despite these efforts, his haemoglobin A₁c (HbA₁c) concentration remains at 8·5%, which is still far from the goal of 7% or less, recommended by his primary care physician. He has no diabetes-related complications, and he is now in your office to discuss additional treatment options for his diabetes control. Recognising that the patient’s haemoglobin A₁c (HbA₁c) concentration has not gone down despite lifestyle intervention and metformin, you engage him in a conversation about intensifying treatment. To aid you in this conversation, you use the Diabetes Medication Choice Decision Aid to facilitate shared decision making as tested in several randomised trials (figure 1 and table 3). Through the course of the dialogue you discover that Mr Jones is fearful of hypoglycaemia. This fear stems from an experience he had while taking glimepiride and is exacerbated by the fact that he lives alone and has limited social support. He selects that card and finds several options not associated with an increased risk of hypoglycaemia. He notes also the card for weight change because he is interested in losing weight, or at least not gaining weight. After deliberating about the available options and how they fit within his values and preferences, together you decide that a DPP-4 inhibitor is the next best medication and agree together on a HbA₁ctarget concentration in the 7·0–8·0% range. Other patients might have prioritised other aspects relevant to the choice of drug; a patient on metformin and more sensitive to out-ofpocket costs might need to address the conflict inherent in selecting between an inexpensive agent that may cause hypoglycaemia (eg, glimepiride) and an expensive one that does not (the DPP-4 inhibitor). Determination of the aspects that are important to the patient beyond the deliberative process does not solve this problem, as some patients may prioritise issues differently as they confront the options. This example highlights a small but critical lesson from the application of shared decision making in practice: to discuss issues with patients and see how the options fare is better than discussing options across relevant issues. Although the former approach tends to create conversations, the latter often results in a lecture.

only involves a set of potential benefits and harms but also brings an obligatory set of activities that will need the patients’ energy, attention, and time.6 Shared decision making can help clinicians uncover the patient’s personal context, and this information can shape a treatment plan that is not only needed, but also wanted and likely to be implemented.3,4 The result of this interaction might also lead to the deintensification of therapy (including the option to forgo so-called indicated treatments) and intensification of supportive interventions.48 Importantly, shared decision making necessitates the use of direct evidence that links treatment plans with outcomes that patients value;12,49 these are outcomes that affect the way patients feel, function, or survive (eg, mortality, myocardial infarction, end-stage renal disease, blindness, amenorrhoea, infertility, acral growth, and colon cancer). In endocrinology, however, many of the treatments are justified on the basis of their effect on surrogate markers (eg, HbA1c, LDL, blood pressure, microalbuminuria, photocoagulation, thyroid-stimulating hormone, prolactin, insulin-like growth factor 1, bone mineral density) that, on the basis of mechanistic rationale, are outcomes that could be of importance to patients.49 For instance, in a cross-sectional study of ongoing randomised clinical diabetes trials,50 only 18% of the primary endpoints were outcomes that were important to patients, despite the strong preference of patients for trials that focus on these outcomes. When treatment decisions are based on surrogate markers without a robust association with patient important outcomes (eg, HbA1c and cardiovascular outcomes; microalbuminuria and end-stage renal disease), the decision-making process will be inaccurate and will become based on preferences that might not be expressed by patients who have been informed by evidence of direct relevance.49 As a result, shared decision making also

For the diabetes decision aid see http://diabetesdecisionaid. mayoclinic.org

Copyright: Mayo Foundation for Research and Education

Figure 2: Statin Choice Decision Aid showing 10-year cardiovascular risk calculator and a pictogram of the current and future cardiovascular risk if a high-dose statin was used Figure shows data for the patient in the example case (panel 2). Produced with permission of the Mayo Foundation for Research and Education.

4

www.thelancet.com/diabetes-endocrinology Published online February 22, 2016 http://dx.doi.org/10.1016/S2213-8587(15)00468-4

Personal View

Body of evidence

Guideline recommendation

Which is the best add-on treatment after metformin has failed to achieve glycaemic control in patients with type 2 diabetes?

Meta-analysis of randomised controlled trials have shown that when combined with metformin, all noninsulin agents were associated with similar HbA₁c reductions but differed in their risk of hypoglycaemia and weight gain; in terms of outcomes that are important to patients no add on-therapy was shown to be superior to another20,21

ADA guideline:47 If the HbA₁c target is not achieved after about 3 months of monotherapy, proceed to two-drug combination choice dependant on variety of patient-specific and disease-specific factors; however, the level of evidence of recommendation is not mentioned; AACE guideline:22 if HbA₁c entry is more than 7·5%, dual therapy is recommended in the order: GLP-1 agonists, SGLT2 inhibitors, DPP-4 inhibitors, thiazolidinediones, basal insulin, colesevelam, bromocriptine quick-release, alpha-glucosidase inhibitors, and sulfonylureas (grade C; BEL 3)

What is the first-line drug for painful diabetic neuropathy?

An umbrella systematic review and comparative-effectiveness network metaanalysis reported that several drugs might be effective; nevertheless, their comparative effectiveness is unclear; few head-to-head clinical trials have been done with inconclusive evidence in favour of one treatment option over another23

AACE guideline:22 Tricyclic antidepressants, anticonvulsants, and serotonin and norepinephrine reuptake inhibitors should be considered for the treatment of painful neuropathy (grade A; BEL 1);AAN, AANEM, and AAPMR guideline:24 pregabalin is established as effective and should be offered for relief of painful diabetic neuropathy (level A)

What is the best diagnostic test for gestational diabetes?

Whether the one-step 75 g or two-step 100 g glucose tolerance test is better at ADA guideline:26 The diagnosis of gestational diabetes can be accomplished with predicting maternal or fetal important outcomes is unclear; no clear consensus either of two strategies (ADA 2015-Classification; level of evidence of exists on which test is best, and different diabetes associations advocate for recommendation not mentioned) different approaches25

What is the best definitive treatment for patients with Graves’ disease?

Results from a meta-analysis27 of one randomised controlled trial and several ATA guideline:28 Patients with overt Graves’ hyperthyroidism should be treated with observational studies has shown that surgery and radioactive iodine are very any of the following modalities: ¹³¹I therapy, antithyroid drugs, or thyroidectomy effective in achieving hypothyroidism; however, these treatment options differ (level of evidence 1/++0) in their safety, convenience, and cost so no option is clearly the best option for everyone

What is the optimal treatment for asymptomatic subclinical hypothyroidism? (TSH 4·5–10 mU/L)

Treatment with levothyroxine has not been assessed in a high-quality head-to-head randomised controlled trial; the treatment remains controversial, and treatment should be tailored to the individual patient29

Should we use statins for primary prevention in a patient with low cardiovascular disease risk?

Results from a meta-analysis of randomised controlled trials have shown that ADA guideline:31 For patients with diabetes aged 40–75 years without additional individuals with a 5-year risk of major CV events of 10% or less, statins have a cardiovascular disease risk factors, consider using moderate-intensity statin and relative risk reduction of 9% for all-cause mortality; nevertheless, many trials lifestyle therapy (level A) included a mix of patients, with some who have cardiovascular disease at baseline and some who do not; no trials have strictly tested primary prevention30

What is the best drug treatment for postmenopausal osteoporosis?

No high-quality head-to-head randomised controlled trials have been designed to determine the optimal drug in terms of efficacy of fracture risk reduction; choice of therapy is recommended on the basis of safety, efficacy, tolerance, cost, and convenience32

NOF Guideline:33 Consider FDA-approved drugs on the basis of history of fractures, hip or lumbar spine densitometry, osteopenia, and overall 10-year FRAX score of more than 20% or hip FRAX score of more than 3%, and patients’ preferences (level of evidence of recommendation not mentioned)

What is the first-line drug treatment for obesity?

Few head-to-head randomised controlled trials exist and yielded uncertain results because of short duration, heterogeneity, and high attrition, and have not assessed patient-important outcomes; results of a meta-analysis34 of randomised placebo-controlled trials comparing pharmacological therapy showed that it promotes modest weight loss without a clear difference of one agent over the other

Endocrine Society guideline:35 If a drug for chronic obesity management is prescribed as adjunctive therapy to comprehensive lifestyle intervention, therapy can be initiated with dose escalation on the basis of efficacy and tolerability to the recommended dose, not exceeding the upper approved dose boundaries; therapy should be tailored depending on underlying cardiovascular disease, hypertension, or concomitant type 2 diabetes (weak recommendation, moderate quality evidence)

What is the best surgical treatment for obesity?

Different restrictive or malabsorptive procedures offer differences in the expected weight loss, re-operation, failure, death, acute and chronic complications; results of a meta-analysis37 of randomised controlled trials and observational studies do not clearly show that one procedure is better than another for every patient; assessment of benefits and potential harms should be assessed before making the decision

ADA guideline:38 Understanding the long-term benefits and risks of bariatric surgery in individuals with type 2 diabetes, especially those who are not severely obese, will necessitate well designed clinical trials, with optimal medical therapy as the comparator (level of evidence of recommendation not mentioned)

What is the optimum diet for weight loss?

Results of a meta-analysis39 of randomised controlled trials showed small weight loss differences between individual weight loss diets; adherence to diet has been identified as the single most important factor for weight loss39

ADA guideline:40 Address individual nutrition needs based on personal and cultural preferences, health literacy and numeracy, access to healthful food choices, willingness and ability to make behavioural changes, and barriers to change (level of evidence of recommendation not mentioned)

What is the best treatment for a patient with asymptomatic primary hyperparathyroidism?

Results of short-term randomised controlled trials and long-term cohort studies have shown that these patients can be safely followed because they do not have disease progression; parathyroidectomy has been shown to improve bone mineral density but does not clearly reduce fractures; it has also been reported to be associated to an improved quality of life41

Endocrine Society guideline:41 Patients who do not meet any guidelines for surgery might appropriately undergo parathyroid surgery as long as there are no medical contraindications; although surgery is clearly an attractive choice in many patients with asymptomatic primary hyperparathyroidism, those who do not meet surgical indications or are unable or unwilling to proceed with parathyroidectomy can be monitored (level of evidence of recommendation not mentioned)

When needed after surgery, what is the best medical treatment for acromegaly?

No randomised controlled trials have shown one therapy to be better than another therapy in terms of important outcomes; combination therapy trials have been small and do not show a clear benefit to a single agent; choice of therapy is recommended after assessing the differences in cost, adverse events, tolerance, and convenience42,43

Endocrine Society guideline:44 In a patient with significant disease (ie, with moderateto-severe signs and symptoms of growth hormone excess and without local mass effects), either a somatostatin analogue (long-acting release ocreotide or lanreotide) or pegvisomant can be used as the initial adjuvant medical therapy (weak recommendation, low quality evidence); Endocrine Society guideline:44 in a patient with only modest increases of serum IGF-1 and mild signs and symptoms of growth hormone excess, a trial of a dopamine agonist, usually cabergoline, can be used as the initial adjuvant medical therapy (weak recommendation, low quality evidence)

ATA guideline:29 Treatment based on individual factors for patients with TSH concentrations between the upper limit of a given laboratory’s reference range and 10 mU/L should be considered, particularly if patients have symptoms suggestive of hypothyroidism or positive antibodies to thyroid peroxidase, or show evidence of atherosclerotic cardiovascular disease, heart failure, or associated risk factors for these diseases (grade B, BEL 1)

(Table 2 continued on next page)

www.thelancet.com/diabetes-endocrinology Published online February 22, 2016 http://dx.doi.org/10.1016/S2213-8587(15)00468-4

5

Personal View

Body of evidence

Guideline recommendation

(Continued from previous page) What is the best testosterone regimen in the treatment of male hypogonadism?

No high quality head-to-head randomised controlled trials have compared different testosterone preparations (intramuscular [long or extra-long acting], oral, transdermal); the decision is made on an individual basis depending on the patient’s preference on the administration route, application site, half-life, and adverse events between the different testosterone formulations45

What is the oestrogen preparation of choice for menopausal hormone therapy?

Different oestrogen preparations exist (oral, transdermal patches, vaginal rings No recommendation with respect to this clinical scenario or creams, subcutaneous implants, topical gels), with no clear benefit of one over the other; the decision is recommended to be taken depending on the patient’s preferences in terms of the administration route, convenience, and adverse events46

What is the best secondline option after a noncurative surgery ACTH-dependant Cushing’s syndrome?

No single approach has clear benefits over another (no head-to-head randomised controlled trials have been done); availability, frequent adverse events, cost, tolerance, and convenience have to be considered in the treatment selection47

Endocrine Society guideline:45 Testosterone therapy can be initiated with any of the regimens and chosen on the basis of the patient’s preference, consideration of pharmacokinetics, treatment burden, and cost (weak recommendation, low quality evidence)

Endocrine Society guideline:47 In patients with ACTH-dependent Cushing’s syndrome who underwent a non-curative surgery or for whom surgery was not possible, a shared decision making approach is an option because there are several available second-line therapies, such as repeat trans-sphenoidal surgery, radiotherapy, medical therapy, and bilateral adrenalectomy (weak recommendation, low quality evidence)

ADA=American Diabetes Association. AACE=American Association of Clinical Endocrinologists. AAN=American Academy of Neurology. AANEM=American Association of Neuromuscular and Electrodiagnostic Medicine. AAPMR=American Academy of Physical Medicine and Rehabilitation. ATA=American Thyroid Association. NOF=National Osteoporosis Foundation. GLP-1=glucagon-like peptide-1. SGLT2=sodium–glucose cotransporter 2. DPP-4=dipeptidyl peptidase 4. BEL=best evidence level. TSH=thyroid-stimulating hormone. FDA=US Food and Drug Administration. ACTH=adrenocorticotropic hormone. IGF1=insulin-like growth factor 1.

Table 2: Examples of common clinical scenarios in endocrinology in which shared decision making could be implemented because of the uncertainty of the available body of evidence

Panel 3: Online decision aids • Knowledge and Evaluation Research Unit, Mayo Clinic (Rochester, MN, USA): http://shareddecisions.mayoclinic.org/decision-aid-information/decision-aids-forchronic-disease/ • Ottawa Hospital Research Institute, University of Ottawa (Ottawa, ON, Canada): https://decisionaid.ohri.ca/AZlist.html • Agency for Healthcare Research and Quality, US Department of Health and Human Services (Rockville, MD, USA): http://effectivehealthcare.ahrq.gov/index.cfm/toolsand-resources/patient-decision-aids/ • Option Grid Collaborative, Dartmouth Institutes for Health Policy and Clinical Practice? (Hanover, NH, USA): http://optiongrid.org/option-grids/current-grids • Healthwise Knowledgebase, Healthwise (Boise, ID, USA): http://www.healthwise.org/ products/decisionaids.aspx • National Health Service, UK: http://sdm.rightcare.nhs.uk/

becomes a strategy that promotes patient-centred care and patient safety because it ensures that everyone gets the right care, which is the care they need and want, no more and no less.

Tools to support shared decision making in endocrinology To the best of our knowledge, there are 25 decision aids that can support shared decision making in endocrinology, some of which are used in the management of diabetes, cardiovascular risk prevention, osteoporosis, thyroid illness, and obesity. Most decision aids can be found and used freely online (panel 3). Of the available decision aids, a few have been tested in randomised trials (table 3).51–67 Overall, in agreement with the results of the Cochrane review,10 these trials show that decision aids improve the ability of patients to make 6

decisions, increase the patients’ knowledge and quality (assessed using the 16-item Decisional Conflict Scale)68 of their decisions, increase the accuracy of perceived risk and confidence to make a decision, and reduce decisional conflict and facilitate a more active role for the patient in the decision-making process. Of note, in nine trials, almost all from the same research group, decision aids were delivered during the patient–clinician encounter and, consequently, had a greater chance of directly promoting deliberation than if the decision aids had been delivered outside the encounter. The process of a collaborative deliberation and the extent to which clinicians involve patients in decisions can be measured using the Observing Patient Involvement in the Decision Making Process (OPTION) Scale.69 The trials have focused on two treatments; hormone replacement treatment and diabetes treatment. Furthermore, these trials were done in high-income countries, whereas the global burden of diabetes is largest in lower and middleincome countries; thus the potential applicability of these results and the usefulness of these decision aids in those settings is unclear. Interestingly, more than 80% of the decision aids that focused on endocrinological disorders have been tested in the primary care setting. This furthers the notion that translation and implementation into endocrine speciality clinics (where more time is available and clinicians are less burdened) might be feasible and reasonable. Given the potential to translate comparative effectiveness research into practice, these decision aids are an unrealised promise to improve patient care.70

Do patients want shared decision making? Although a patient’s desire for involvement might depend on many factors (eg, religion, type of decision

www.thelancet.com/diabetes-endocrinology Published online February 22, 2016 http://dx.doi.org/10.1016/S2213-8587(15)00468-4

Personal View

Center

Population

Setting

Type of intervention

Population size

Arteburn and colleagues (2011)51

Group Health Research Institute, USA

Adults with a BMI ≥35 kg/m² (aged 20–65 years)

One speciality Decision for clinic bariatric surgery

Decision

Video decision aid (outside the encounter) vs educational booklet (control)

Improved decision quality and reduced 75 patients in intervention group; 77 patients in control uncertainty about treatment at 3 months group

Decision aid outcomes

Bastian and colleagues (2002)52

Durham VA Medical Center (USA)

Women in menopause (aged 45–54 years)

Primary care clinic

Decision for hormone replacement therapy

289 patients in active Computer-tailored, three-step decision aid intervention; no data for delayed intervention active intervention (outside the encounter) vs delayed intervention

Improved patients’ability to make decisions; increased accuracy of perceived risk and confidence to make a decision

Branda and Knowledge and colleagues Evaluation (2013)53 Research Unit (USA)

Adults who had type 2 diabetes for ≥1 year

Ten nonacademic and rural primary care practices

Decision about starting statins or diabetes medication

Decision aid diabetes 53 patients in intervention and statin cards (inside group; 50 patients in control the encounter) vs usual group care (control)

Decreased decisional conflict and increased knowledge; patients were more likely to discuss their drugs and were more engaged by their clinicians in decision making process

Dodin and colleagues (2001)54

Hospital SanFrancois d’Assiese (Canada)

Women in menopause (aged 45–69 years)

Multiple primary care practices

Decision for hormone replacement therapy

Detailed manual decision aid (outside the encounter) vs usual care (control)

52 patients in the intervention group; 49 patients in the control group

Increased congruence between personal values and patients’ decisions about hormone replacement therapy; increased patient knowledge of the risks and benefits of hormone replacement therapy

Denig and colleagues (2014)55

University Medical Center Groningen (Netherlands)

Adults with type 2 diabetes who were ≤65 years of age at time of diagnosis

18 general practices

Decision to prioritise goals in diabetes

Decision aids (inside and outside the encounter) vs usual care (control)

225 patients in the intervention group; 119 patients in the control group

The mean empowerment score increased 0·1 on a 5-point scale in the overall intervention group and was not significant

LeBlanc and colleagues (2015)56

Knowledge and Evaluation Research Unit (USA)

Women with osteopenia or osteoporosis(aged >50 years)

Multiple primary care practices

Decision for osteoporosis treatment

Tailored pictographic cards decision aids (inside the encounter) vs FRAX score estimates vs usual care (control)

32 patients in the intervention group; 33 patients in the FRAX group; 14 patients in control group

Increased patient knowledge, improved understanding of fracture risk and risk reduction with bisphosphonates, and increased patient engagement in the decision making process; encounters were only 0·8 min longer, and twice as many patients filled prescriptions in the decision aid group compared with both usual care and FRAX groups

Legare and colleagues (2003)57

Ottawa Hospital (Canada)

Women who had been post-menopausal for ≥1 year (aged 45–69 years)

Primary care practices

Decision for hormone replacement therapy

Pamphlet decision aid (outside the encounter) vs usual care (control)

97 patients in the intervention group; 87 patients in the control group

Improved agreement between patients and doctors

Mann and colleagues (2010)58

Knowledge and Evaluation Research Unit (USA)

Adult patients with type 2 diabetes

Primary care practices

To assess whether Decision aid cards (inside the encounter) statin choice vs pamphlet (control) improves risk perceptions and drug adherence

80 patients in the intervention group; 70 patients in the control group

Patients are more likely to accurately perceive their underlying risk for a heart attack; improved risk communication, beliefs, and decisional conflict but did not improve adherence to statins

Mathers and colleagues (2012)59

University of Sheffield (UK)

Patients with type 2 49 general practices diabetes (aged >21 years)

Monotori and colleagues (2011)60

Knowledge and Evaluation Research Unit (USA)

Postmenopausal women with osteopenia or osteoporosis (aged >50 years)

Mullan and Knowledge and colleagues Evaluation (2009)61 Research Unit (USA)

Adult patients who had type 2 diabetes for ≥1 year

Murray and University colleagues College London (2001)62 (UK)

Women considering 26 general medicine hormone practices replacement therapy

Decision of insulin or other diabetes drugs

Decision aid (inside and outside the encounter) vs usual care (control)

25 patients in the intervention group; 24 patients in the control group

Reduced decisional conflict, improved knowledge, and promoted realistic expectations and autonomy

Ten general medicine and primary care practices

Decision to initiate osteoporosis treatment

Tailored pictographic cards decision aids (inside the encounter) vs standard brochure (control)

52 patients in the intervention group; 48 patients in the control group

More likely to correctly identify patient’s 10-year fracture risk; improved patient involvement in the decision; improved quality of clinical decisions; proportion with more than 80% adherence was highest with the decision aid

11 primary care and family medicine practices

Decision of diabetes starting medication

Decision aid cards (inside the encounter) vs educational pamphlet (control)

48 patients in the intervention group; 37 patients in the control group

Improved patients’ knowledge and involvement in making decisions about diabetes drugs

Decision for hormone replacement therapy

Interactive multimedia programme (outside the encounter) vs standard care (control)

103 patients in the intervention group; 102 patients in the control group

Decreased decisional conflict and let patients have a more active role in decision making without increasing anxiety (Table 3 continued on next page)

www.thelancet.com/diabetes-endocrinology Published online February 22, 2016 http://dx.doi.org/10.1016/S2213-8587(15)00468-4

7

Personal View

Center

Population

Setting

Decision

Type of intervention

Population size

Decision aid outcomes

Use of statins to reduce cardiovascular risk

Decision aid cards (inside the encounter) vs pamphlet (control)

86 patients in the intervention group; 82 patients in the control group

Improved patient’s knowledge, perception of the 10-year cardiovascular risk, and satisfaction

Decision for hormone therapy replacement

Computer decision aid (outside the encounter) vs audio-booklet decision aid (control)

25 patients in the intervention group; 26 patients in the control group

Computer decision aid improved realistic expectations and improved the patients’ knowledge

(Continued from previous page) Patients with type 2 14 primary care practices diabetes (aged >18 years)

PeresteloPerez and colleagues (2015)63

Evaluation Unit of the Canary Islands Health Service (Spain)

Rostom and colleagues (2002)64

University of Women considering Various medical Ottawa (Canada) hormone clinics replacement therapy (aged 40–70 years)

Sawka and colleagues (2012)65

University Health Network and University of Toronto (Canada)

Speciality Patients with early-stage papillary clinic thyroid cancer after thyroidectomy

Decision for adjuvant radioactive iodine in patients with low risk papillary thyroid cancer

Computer decision aid (outside the encounter) vs usual care (control)

37 patients in the intervention group; 37 patients in the control group

Patients had more knowledge about the disease and treatment; had less decisional conflict

Schapira and colleagues (2007)66

VA Medical Center, Wisconsin (USA)

Primary care Postmenopausal women considering practice hormone replacement therapy

Decision for hormone replacement therapy

Computer decision aid (outside the encounter) vs pamphlet (control)

89 patients in the intervention group; 88 patients in the control group

A non-significant trend was reported toward decreasing decisional conflict

Weymiller and colleagues (2007)67

Knowledge and Evaluation Research Unit (USA)

Patients with type 2 Speciality clinic diabetes and no contraindications to statin use

Decision aid cards Decision for statin initiation in (inside the encounter) vs pamphlet (control) patients with diabetes

52 patients in the intervention group; 46 patients in the control group

Patients had more knowledge, better estimated cardiovascular risk, and potential absolute risk reduction with statins; less decisional conflict

PTC=papillary thyroid cancer.

Table 3: Decision aids tested in randomised clinical trials in endocrinology

made, culture), research across several medical disorders has shown that most people want to be informed and involved in decisions about their own health care. In a study71 in the USA, eight of ten adult patients wanted their clinicians to listen; nevertheless, less than 60% of patients reported being listened to. Likewise, fewer than half of the patients said their clinician asked about their particular goals and concerns with respect to their health and health care.71 However, patients who reported that their physician listened to their goals and preferences were three to five times more satisfied with this care.71 In a study72 that involved 994 patients with type 2 diabetes, 89% of the patients reported that targets should be set in cooperation with their clinician or diabetes educator (nurse), particularly those patients with diabetes complications (odds ratio 1∧98 [95% CI 1∧03–3∧80]). Interestingly, patients who perceived dysfunction by barriers to activity did not agree to take responsibility for their diabetes (3∧68 [1∧65–8∧19]). In another survey,73 70% of patients who were asked about their role in decision making said they preferred shared decision making, and only 19% of patients favoured a more paternalistic approach, in which clinicians are mostly, if not solely, responsible for taking decisions. This enthusiasm for an active role in the treatment decision might, however, be tempered by the fact that patients reported fear of being classified as difficult if they were to express their preference during a clinical encounter.74 The familiarity and implementation of the principles underlying shared decision making 8

could certainly help overcome this barrier, both from the patient’s and clinician’s perspective (table 1).

Barriers to shared decision making Despite the increasing evidence and recommendations, shared decision making and decision aids are not routinely implemented in endocrinology. This discordance might be a reflection of the many barriers and challenges that need to be overcome. One of the most common barriers is the clinician’s belief that they are already incorporating patients’ preferences into management decisions.3 However, the preferences that clinicians believe they are incorporating are often misdiagnosed. In a cross-sectional study75 that compared patients’ and healthcare providers’ perspectives to identify the most important facts and goals for decisions about breast reconstruction after mastectomy, clinicians thought that 71% of their patients rated keeping their breasts as a top priority and that 96% of their patients rated living as long as possible as a top priority. Nevertheless, only 7% of the patients valued breast conservation, and 59% of the patients rated living as long as possible as their most important health priority.75 Another challenge to shared decision making is the belief that its implementation could considerably increase consultation time for clinicians who already have a busy and tight schedule. A systematic review of decision aids found that the length of the encounter varied from 8 min shorter to 23 min longer than the average (median 2∙55 min longer).10 These averages do not show the efficiency that was probably gained with

www.thelancet.com/diabetes-endocrinology Published online February 22, 2016 http://dx.doi.org/10.1016/S2213-8587(15)00468-4

Personal View

repeated use, although reliable evidence in support of this expectation does not exist. Identification of those clinical situations in which shared decision making is appropriate is challenging.6 Evidence should be shared and the values and context of the patients’ respected in most clinical encounters. However, the extent to which patients are willing and able to engage in deliberation varies. Thus, the imposition of shared decision making to every patient without appraising the desire or capacity of the patient to be engaged in the decision process is not consistent with the practice of evidence-based medicine. Consequently, clinicians should practice shared decision making empathically by focusing attention to verbal and non-verbal patient cues about the desired degree of engagement. This real-time assessment of the patient preference might adequately result in patients partially or fully delegating the decision to the clinicians.

Future directions We have highlighted the role for shared decision making in endocrinology and the decision aids that exist to support certain conversations underlying the process. Ongoing trials, such as a 2 year follow-up study76 testing a diabetes decision aid in over 40 general practices, are trying to advance the knowledge in this matter. However, to realise the full potential of this patient–clinican relationship, more needs to be done. The development and testing of new and existing ways to facilitate shared decision making for a variety of endocrine disorders is warranted. Furthermore, clinical practice guidelines should provide guidance for disorders in which the approach is feasible and support research of its application; particularly because most recommendations in endocrine guidelines are based on low or very low quality evidence.1,2,19 Clinical practice guidelines are mostly silent on the issue of shared decision making at present. In the latest guidelines for ten classic endocrine diseases (diabetes, hypothyroidism, hyperthyroidism, obesity, osteoporosis, testosterone therapy, polycystic ovary syndrome, hyperparathyroidism, acromegaly, and Cushing’s syndrome),28,29,33,35,36,41,44,45,47,77 only three statements35,36,47 explicitly advocate for this approach. In 2015, guidelines published by the American Diabetes Association and the European Association for the Study of Diabetes promoted a patient-centred approach in which shared decision making could be incorporated.36 Similarly, the Endocrine Society highlighted shared decision making as a strategy to improve patients’ knowledge, conflict, and reduce regret when choosing a specific weight-loss medication in obesity management and for patients with Cushing’s syndrome who underwent non-curative pituitary surgery or for whom surgery was not possible.35,47 There is no guidance for clinicians on how to practice shared decision making or which strategies or aids to use. This gap in the promotion of shared decision making and decision aids by endocrinology guidelines could be

Search strategy and selection criteria We searched PubMed (MEDLINE) and Google Scholar for articles published before Jan 15, 2016, in English about shared decision making using the terms “shared decision making”, “decision aids”, “endocrinology”, and “evidence-based medicine”. We reviewed the articles resulting from these searches and relevant references cited in those articles. To identify whether any of the decision aids have evidence of efficacy as determined by a randomised trial, we did, in duplicate, a comprehensive search in PubMed for articles published between January, 1990, and October, 2015, using the terms “decision aids”, “decision support”, “decision making”, “patient decision making”, “endocrinology”, and “shared decision making”. We supplemented this list by searching decision aid websites, Google Scholar, references from previous systematic reviews about shared decision making, and finally consulted with experts on shared decision making; all with the intent of incorporating additional references that could have been missed by our initial search strategy.

improved through the use of new technologies that allow the generic and semi-automated production of decision aids. The not-for-profit MAGIC project (Making GRADE the Irresistible Choice) allows authors of guidelines to write evidence summaries into a structured database, and this evidence can be turned into an electronic decision aid for use in the clinical encounter.15 In addition to guidelines, medical journals and policy makers in endocrinology should also encourage practice and research of shared decision making. A clear example of this effort comes from the cardiology journal Circulation: Cardiovascular Quality and Outcomes, which published a special edition devoted to shared decision making.78 Policy makers can support the approach by creating a system in which patient-centred care is valued and invested in and where metrics show outcomes that are important to patients and do not conflict with patient preferences.7 This action can be furthered through active research to show its effectiveness at improving outcomes. Finally, shared decision making is not a panacea for patient-centred care, but provides a way for clinicians to support patients in their pursuit of good health, to guide patients as they struggle with illness and disease, and to support them in making difficult decisions and deliberating about what is best for themselves and for their families. Only through thoughtful implementation and a commitment to honour the patient, to respect and integrate their values, and consider their goals and context can patient-centred care truly be practiced.

For the MAGIC project see http://www.magicproject.org

Contributors RRG, VMM, and JPB designed the search strategy and wrote and reviewed the report. MG, NSO, MS, and ST helped with the search strategy, contributed to the writing and critical revision of the report, and helped with submissions. All authors read and approved the final draft before submission.

www.thelancet.com/diabetes-endocrinology Published online February 22, 2016 http://dx.doi.org/10.1016/S2213-8587(15)00468-4

9

Personal View

Declaration of interests RRG, MRG, NSO, MS, ST, VMM, and JPB work on designing and testing shared decision-making tools, but these tools are freely available (http://shareddecisions.mayoclinic.org) and do not generate income for them, their research group, or their institution. All other authors declare no competing interests.

20

Acknowledgments This work was made possible by a CTSA grant (number TL1 TR000137, to MRG) from the US National Center for Advancing Translational Science, part of the National Institutes of Health (NIH). The contents of this report are solely the responsibility of the authors and do not necessarily represent the official views of the NIH. We thank the Patient Research Advisory Group, a group of patients with diabetes from the community that has met with investigators of the Knowledge and Evaluation Research Unit at the Mayo Clinic (Rochester, MN, USA) for the past decade to help direct their work on what matters to patients.

22

References 1 Hazlehurst JM, Armstrong MJ, Sherlock M, et al. A comparative quality assessment of evidence-based clinical guidelines in endocrinology. Clinical Endocrinol 2013; 78: 183–90. 2 Brito JP, Domecq JP, Murad MH, Guyatt GH, Montori VM. The Endocrine Society guidelines: when the confidence cart goes before the evidence horse. J Clin Endocrinol Metab 2013; 98: 3246–52. 3 Stiggelbout AM, Van der Weijden T, De Wit MP, et al. Shared decision making: really putting patients at the centre of healthcare. BMJ 2012; 344: e256. 4 Barry MJ, Edgman-Levitan S. Shared decision making–pinnacle of patient-centered care. New Engl J Med 2012; 366: 780–81. 5 Charles C, Gafni A, Whelan T. Decision-making in the physician-patient encounter: revisiting the shared treatment decision-making model. Soc Sci Med 1999; 49: 651–61. 6 Elwyn G, Lloyd A, May C, et al. Collaborative deliberation: a model for patient care. Patient Educ Couns 2014; 97: 158–64. 7 Department of Health. Equity and excellence: liberating the NHS. July, 2010. London: UK Government, 2010. 8 Washington State Legislature. RCW 41.05.033. Shared decision-making demonstration project—preference-sensitive care. 2007. http://apps.leg.wa.gov/rcw/default.aspx?cite=41.05.033 (accessed July 17, 2015). 9 Representatives SaHo. Patient Protection and Affordable Care Act. HR 3590. Aug 25, 2010. https://www.govtrack.us/congress/ bills/111/hr3590/text (accessed July 17, 2015). 10 Stacey D, Légaré F, Col NF, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev 2014; 1: CD001431. 11 Frosch DL, Moulton BW, Wexler RM, et al. Shared decision making in the United States: policy and implementation activity on multiple fronts. Z Evid Fortbild Qual Gesundhwes 2011; 105: 305–12. 12 Guyatt G, Meade MO, Rennie D, Cook DJ. Users’ guides to the medical literature: a manual for evidence-based clinical practice, 3rd edn. New York: McGraw Hill, 2015. 13 Committee on Quality of Health Care in America. Institute of Medicine. Crossing the quality chasm: a new health system for the 21st century. Washington, DC: National Academies Press, 2001. 14 Drake RE, Deegan PE. Shared decision making is an ethical imperative. Psychiatr Serv 2009; 60: 1007. 15 Agoritsas T, Heen AF, Brandt L, et al. Decision aids that really promote shared decision making: the pace quickens. BMJ 2015; 350: g7624. 16 Zipkin DA, Umscheid CA, Keating NL, et al. Evidence-based risk communication: a systematic review. Ann Intern Med 2014; 161: 270–80. 17 Durand MA, Carpenter L, Dolan H, et al. Do interventions designed to support shared decision-making reduce health inequalities? A systematic review and meta-analysis. PLoS One 2014; 9: e94670. 18 America SaHoRotUSo. The Patient Protection and Affordable Care Act (PPACA; Pub. L No. 11-148). Washington, DC: Daily Compilation of Presidential Documents, 2010. 19 Singh Ospina N, Rodriguez-Gutierrez R, Brito JP, Young WF Jr, Montori VM. Is the endocrine research pipeline broken? A systematic evaluation of the Endocrine Society clinical practice guidelines and trial registration. BMC Med 2015; 13: 187.

10

21

23

24

25

26 27

28

29

30

31 32

33

34

35

36

37 38

39

40

Monami M, Lamanna C, Marchionni N, Mannucci E. Comparison of different drugs as add-on treatments to metformin in type 2 diabetes: a meta-analysis. Diabetes Res Clin Pract 2008; 79: 196–203. Phung OJ, Scholle JM, Talwar M, Coleman CI. Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in type 2 diabetes. JAMA 2010; 303: 1410–18. Handelsman Y, Bloomgarden ZT, Grunberger G, et al. American Association of Clinical Endocrinologists and American College of Endocrinology—clinical practice guidelines for developing a diabetes mellitus comprehensive care plan—2015. Endocr Pract 2015; 21 (suppl 1): 1–87. Griebeler ML, Morey-Vargas OL, Brito JP, et al. Pharmacologic interventions for painful diabetic neuropathy: an umbrella systematic review and comparative effectiveness network meta-analysis. Ann Intern Med 2014; 161: 639–49. Bril V, England J, Franklin GM, et al. Evidence-based guideline: Treatment of painful diabetic neuropathy: report of the American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation. Neurology 2011; 76: 1758–65. Agarwal MM, Dhatt GS, Othman Y. Gestational diabetes: differences between the current international diagnostic criteria and implications of switching to IADPSG. J Diabetes Complications 2015; 29: 544–39. American Diabetes Association. (2) Classification and diagnosis of diabetes. Diabetes Care 2015; 38 (suppl): S8–S16. Sundaresh V, Brito JP, Wang Z, et al. Comparative effectiveness of therapies for Graves’ hyperthyroidism: a systematic review and network meta-analysis. J Clin Endocrinol Metab 2013; 98: 3671–77. Bahn Chair RS, Burch HB, Cooper DS, et al. Hyperthyroidism and other causes of thyrotoxicosis: management guidelines of the American Thyroid Association and American Association of Clinical Endocrinologists. Thyroid 2011; 21: 593–646. Garber JR, Cobin RH, Gharib H, et al. Clinical practice guidelines for hypothyroidism in adults: cosponsored by the American Association of Clinical Endocrinologists and the American Thyroid Association. Thyroid 2012; 22: 1200–35. Mihaylova B, Emberson J, Blackwell L, et al. The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. Lancet 2012; 380: 581–90. American Diabetes Association. (8) Cardiovascular disease and risk management. Diabetes Care 2015; 38 (suppl): S49–57. Crandall CJ, Newberry SJ, Diamant A, et al. Comparative effectiveness of pharmacologic treatments to prevent fractures: an updated systematic review. Ann Intern Med 2014; 161: 711–23. Cosman F, de Beur SJ, LeBoff MS, et al. Clinician’s guide to prevention and treatment of osteoporosis. Osteoporos Int 2014; 25: 2359–81. Ara R, Blake L, Gray L, et al. What is the clinical effectiveness and cost-effectiveness of using drugs in treating obese patients in primary care? A systematic review. Health Technol Assess 2012; 16: iii–xiv, 1–195. Apovian CM, Aronne LJ, Bessesen DH, et al. Pharmacological management of obesity: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2015; 100: 342–62. Chang SH, Stoll CR, Song J, Varela JE, Eagon CJ, Colditz GA. The effectiveness and risks of bariatric surgery: an updated systematic review and meta-analysis, 2003–2012. JAMA Surg 2014; 149: 275–87. American Diabetes Association. (7) Approaches to glycemic treatment. Diabetes Care 2015; 38 (suppl): S41-8. Johnston BC, Kanters S, Bandayrel K, et al. Comparison of weight loss among named diet programs in overweight and obese adults: a meta-analysis. JAMA 2014; 312: 923–33. American Diabetes Association. (4) Foundations of care: education, nutrition, physical activity, smoking cessation, psychosocial care, and immunization. Diabetes Care 2015; 38 (suppl): S20–30. Bilezikian JP, Brandi ML, Eastell R, et al. Guidelines for the management of asymptomatic primary hyperparathyroidism: summary statement from the Fourth International Workshop. J Clin Endocrinol Metab 2014; 99: 3561–69.

www.thelancet.com/diabetes-endocrinology Published online February 22, 2016 http://dx.doi.org/10.1016/S2213-8587(15)00468-4

Personal View

41

42

43

44

45

46

47

48 49 50

51

52

53

54

55

56

57

58

59

60

61

Murray RD, Melmed S. A critical analysis of clinically available somatostatin analog formulations for therapy of acromegaly. J Clin Endocrinol Metab 2008; 93: 2957–68. Colao A, Bronstein MD, Freda P, et al. Pasireotide versus octreotide in acromegaly: a head-to-head superiority study. J Clin Endocrinol Metab 2014; 99: 791–99. Katznelson L, Laws ER Jr, Melmed S, et al. Acromegaly: an endocrine society clinical practice guideline. J Clin Endocrinol Metab 2014; 99: 3933–51. Bhasin S, Cunningham GR, Hayes FJ, et al. Testosterone therapy in men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2010; 95: 2536–59. Baker VL. Alternatives to oral estrogen replacement. Transdermal patches, percutaneous gels, vaginal creams and rings, implants, other methods of delivery. Obstet Gynecol Clin North Am 1994; 21: 271–97. Nieman LK, Biller BM, Findling JW, et al. Treatment of Cushing’s syndrome: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2015; 100: 2807–31. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2015; 38: 140–49. May C, Montori VM, Mair FS. We need minimally disruptive medicine. BMJ 2009; 339: b2803. Yudkin JS, Lipska KJ, Montori VM. The idolatry of the surrogate. BMJ 2011; 343: d7995. Murad MH, Shah ND, Van Houten HK, et al. Individuals with diabetes preferred that future trials use patient-important outcomes and provide pragmatic inferences. J Clin Epidemiol 2011; 64: 743–48. Arterburn DE, Westbrook EO, Bogart TA, Sepucha KR, Bock SN, Weppner WG. Randomized trial of a video-based patient decision aid for bariatric surgery. Obesity 2011; 19: 1669–75. Bastian LA, McBride CM, Fish L, et al. Evaluating participants’ use of a hormone replacement therapy decision-making intervention. Patient Educ Couns 2002; 48: 283–91. Branda ME, LeBlanc A, Shah ND, et al. Shared decision making for patients with type 2 diabetes: a randomized trial in primary care. BMC Health Services Res 2013; 13: 301. Dodin S, Légaré F, Daudelin G, Tetroe J, O’Connor A. Making a decision about hormone replacement therapy. A randomized controlled trial. Can Fam Physician 2001; 47: 1586–93 (in French). Denig P, Schuling J, Haaijer-Ruskamp F, Voorham J. Effects of a patient oriented decision aid for prioritising treatment goals in diabetes: pragmatic randomised controlled trial. BMJ 2014; 349: g5651. LeBlanc A, Wang AT, Wyatt K, et al. Encounter decision aid vs. clinical decision support or usual care to support patient-centered treatment decisions in osteoporosis: the Osteoporosis Choice Randomized Trial II. PLoS One 2015; 10: e0128063. Légaré F, O’Connor AM, Graham ID, et al. The effect of decision aids on the agreement between women’s and physicians’ decisional conflict about hormone replacement therapy. Patient Educ Couns 2003; 50: 211–21. Mann DM, Ponieman D, Montori VM, Arciniega J, McGinn T. The Statin Choice decision aid in primary care: a randomized trial. Patient Educ Couns 2010; 80: 138–40. Mathers N, Ng CJ, Campbell MJ, Colwell B, Brown I, Bradley A. Clinical effectiveness of a patient decision aid to improve decision quality and glycaemic control in people with diabetes making treatment choices: a cluster randomised controlled trial (PANDAs) in general practice. BMJ Open 2012; 2: pii: e001469. Montori VM, Shah ND, Pencille LJ, et al. Use of a decision aid to improve treatment decisions in osteoporosis: the osteoporosis choice randomized trial. Am Journal Med 2011; 124: 549–56. Mullan RJ, Montori VM, Shah ND, et al. The diabetes mellitus medication choice decision aid: a randomized trial. Arch Intern Med 2009; 169: 1560–68.

62

63

64

65

66

67

68 69

70

71

72

73

74

75

76

77

78

Murray E, Davis H, Tai SS, Coulter A, Gray A, Haines A. Randomised controlled trial of an interactive multimedia decision aid on hormone replacement therapy in primary care. BMJ 2001; 323: 490–93. Perestelo-Pérez L, Rivero-Santana A, Boronat M, et al. Effect of the statin choice encounter decision aid in Spanish patients with type 2 diabetes: a randomized trial. Patient Educ Couns 2015; published online Sept 1. DOI:10.1016/j.pec.2015.08.032. Rostom A, O’Connor A, Tugwell P, Wells G. A randomized trial of a computerized versus an audio-booklet decision aid for women considering post-menopausal hormone replacement therapy. Patient Educ Couns 2002; 46: 67–74. Sawka AM, Straus S, Rotstein L, et al. Randomized controlled trial of a computerized decision aid on adjuvant radioactive iodine treatment for patients with early-stage papillary thyroid cancer. J Clin Oncol 2012; 30: 2906–11. Schapira MM, Gilligan MA, McAuliffe T, Garmon G, Carnes M, Nattinger AB. Decision-making at menopause: a randomized controlled trial of a computer-based hormone therapy decision-aid. Patient Educ Couns 2007; 67: 100–07. Weymiller AJ, Montori VM, Jones LA, et al. Helping patients with type 2 diabetes mellitus make treatment decisions: statin choice randomized trial. Arch Int Med 2007; 167: 1076–82. O’Connor AM. Validation of a decisional conflict scale. Med Decis Making 1995; 15: 25–30. Elwyn G, Edwards A, Wensing M, Hood K, Atwell C, Grol R. Shared decision making: developing the OPTION scale for measuring patient involvement. Qual Saf Health Care 2003; 12: 93–99. Shah ND, Mullan RJ, Breslin M, Yawn BP, Ting HH, Montori VM. Translating comparative effectiveness into practice: the case of diabetes medications. Med Care 2010; 48 (6 suppl): S153–58. Alston LPC, Halvorson G, Novelli B, et al. Communicating with patients on health care evidence. Discussion Paper, Institute of Medicine. September, 2012. http://www1.marathon-health.com/ wp-content/uploads/2012/10/VSRT-Evidence.pdf (accessed July 20, 2015). Gorter KJ, Tuytel GJ, de Leeuw RR, Bensing JM, Rutten GE. Opinions of patients with type 2 diabetes about responsibility, setting targets and willingness to take medication. A cross-sectional survey. Patient Educ Couns 2011; 84: 56–61. Adams JR, Elwyn G, Légaré F, Frosch DL. Communicating with physicians about medical decisions: a reluctance to disagree. Arch Internal Med 2012; 172: 1184–86. Frosch DL, May SG, Rendle KA, Tietbohl C, Elwyn G. Authoritarian physicians and patients’ fear of being labeled ‘difficult’ among key obstacles to shared decision making. Health Affairs 2012; 31: 1030–38. Lee CN, Hultman CS, Sepucha K. Do patients and providers agree about the most important facts and goals for breast reconstruction decisions? Ann Plast Surg 2010; 64: 563–66. den Ouden H, Vos RC, Reidsma C, Rutten GE. Shared decision making in type 2 diabetes with a support decision tool that takes into account clinical factors, the intensity of treatment and patient preferences: design of a cluster randomised (OPTIMAL) trial. BMC Fam Pract 2015; 16: 27. Legro RS, Arslanian SA, Ehrmann DA, et al. Diagnosis and treatment of polycystic ovary syndrome: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2013; 98: 4565–92. American Heart Association. Circ CQO: new shared decision making series. http://my.americanheart.org/professional/ ScienceNews/Circ-CQO-New-Shared-Decision-Making-Series_ UCM_461665_Article.jsp#.Vqzn6rIrJpg http://circoutcomes. ahajournals.org/ (accessed Feb 4, 2015).

www.thelancet.com/diabetes-endocrinology Published online February 22, 2016 http://dx.doi.org/10.1016/S2213-8587(15)00468-4

11