De-implementing low value care in endocrinology

Summary

Low value care exposes patients to ineffective, costly, and potentially harmful care. In endocrinology, low value care practices are common in the care of patients with highly prevalent conditions. There is an urgent need to move past the identification of these practices to an active process of de-implementation. However, clinicians, researchers and other stakeholders might lack familiarity with the frameworks and processes that can help guide successful de-implementation. To address this gap and support de-implementation of low value care, we provide a summary of low value care practices in endocrinology and a primer on the fundamentals of de-implementation science. Our goal is to increase awareness of low value care within endocrinology and suggest a path forward for addressing low value care using principles of de-implementation science.

Introduction

The National Academy of Medicine supports the vision of a health system that optimizes its performance to promote, protect, and restore the health of individuals and populations, and helps individuals reach their full potential for health and well-being.[1] However, the current health care delivery system is inefficient, in part due to the paradox surrounding the lack of translation and implementation of effective clinical interventions coupled with the widespread use of low value care – care that confers little or no benefit to patients or where the risk of harm exceeds the likely benefit.[1, 2]

The prevalence of low value care is difficult to measure due to the lack of a universally accepted definition.[3] A review that evaluated more than 50 low value care practices in four countries found that overuse ranged between 0.3% and 73%.[3] Although commonly associated with potential economic waste, the negative consequences of low value care expand on multiple domains – physical, psychological, treatment burden, social, financial, and overall satisfaction with the healthcare system – and can be both proximal and distal.[4, 5]

De-implementation has emerged as a promising approach to reduce low value care. De-implementation is the process of reducing or stopping the use of a practice, intervention, or program provided to patients by healthcare practitioners and systems when these practices are considered ineffective, unproven, harmful, or low-value.[6-8] The objective of this review is to guide clinicians, researchers, and policy makers with an overview of how de-implementation science could be applied to reduce low value care in the field of endocrinology.

Search strategy and article selection

References for this narrative review were identified through searches on PubMed and Scopus for articles published between January 1, 2000 and November 16, 2020 using the terms: “de-implementation”, “low value care”, “endocrinology”, “diabetes”, “thyroid”, “hypothyroidism”, “thyroid disease”, “osteoporosis”, and “hyperthyroidism”. The search strategy was updated on March 23, 2021 to include the terms “vitamin D”, “testosterone” and “hypogonadism” due to the identification of these possible areas of low value care in other sources (guidelines). Relevant articles resulting from these searches and relevant references cited in these articles were reviewed. References provided by experts and in the authors’ personal files were reviewed. Articles published in English were included. In addition, the websites of the Endocrine Society, American Thyroid Association, US Preventive Services Task Force (USPSTF) and the Choosing Wisely campaign were reviewed to identify potential areas of low value care.[9-12] The goal was to use different methods to identify possible areas of low value care in endocrinology, however, our findings are not exhaustive.

Addressing low value care using principles of de-implementation science

De-implementation science focuses on: 1) identifying areas of low value and wasteful practice, 2) conducting rigorous scientific investigation of the factors that initiate and maintain them, and 3) introducing evidence-based interventions to cease these practices.[13]

Multiple frameworks have been used to conceptualize and explain the process and determinants of de-implementation science.[13-16] In fact, Nilsen et al identified 10 theories, models, and frameworks used to understand de-implementation of low value care.[16-19] We will focus on the model by Niven et al to guide our discussion. [19] This model focuses on: 1) Identifying and prioritizing areas of low value care; 2) Facilitating the process of de-implementation; 3) Evaluating the outcomes of de-implementation; and 4) Sustaining de-implementation. (Figure 1)

Figure 1.

Steps and factors that guide the de-implementation process.

1. Identify and prioritize areas of low value care

The first step in de-implementing low value care is to identify such practices that result in no benefit. [6, 19, 20] In fact, an initial focus of de-implementation science has been to reduce or replace interventions that are clearly ineffective, based on clinical evidence.[20] Assessment of clinical evidence can identify practices that are ineffective (e.g., routine treatment of older patients with mild subclinical hypothyroidism), cases where newer or higher quality evidence now suggests the practice is contradicted (e.g., intensive glycemic control for hospitalized patients), conflicted results (e.g., screening for thyroid disease during pregnancy) or untested practices that lack trusted evidence (e.g., use of computer aided tools for the diagnosis of thyroid nodules in routine practice). [8, 19-24]

The low value care typology introduced by Verkerk et al[25] provides a broader definition of low value care and recommends de-implementation strategies according to the clinical evidence (i.e., benefits and harms) and sensitive to the patient’s situation and preferences. Low value care can be:

1. ineffective, whereby the patient clearly does not need an intervention, requiring macro-level strategies to limit the use of this practice (e.g., routine treatment of older patients with mild subclinical hypothyroidism with levothyroxine),

2. inefficient, referring to care that is effective but for which the delivery is inadequate, requiring improvement in healthcare delivery (e.g., over-testing of hemoglobin A1c in patients with controlled type 2 diabetes) and,

3. unwanted, where the clinical practice does not solve the problem of the patient or does not meet patient preferences (e.g., offering aggressive treatment to a patient with micro-papillary thyroid cancer, with limited life expectancy and conservative preferences).[21, 26] In these circumstances, the goal is to support the patient-clinician interaction and understand the patient’s situation.

This broader definition of low value care highlights the complexity by which some clinical situations focusing on evidence alone might not clarify whether care is appropriate. [25] Once a practice has been identified as low value care, understanding the magnitude of the problem, by assessing the prevalence, expected harm and available resources can help prioritize practices for de-implementation.[6, 27]

We have summarized possible areas of low value care in endocrinology by formulating a list of: 1) strong recommendations, based on high quality evidence, suggesting de-implementation of medical interventions included in the Endocrine Society and the American Thyroid Association guidelines since 2010, 2) recommendations by the USPSTF addressing endocrine conditions, 3) recommendations included in the Choosing Wisely campaign addressing endocrine conditions, and 4) recommendations related to endocrinology included in a recent study that evaluated a process to identify and formulate recommendations for stopping or scaling back on unnecessary routine care in primary care.[26, 28-35] (Table 1) In addition, we have selected a few practices to highlight the clinical evidence, impact, and potential actions for de-implementation.[6, 7, 10, 21, 27, 36-43] (Table 2) This list is not exhaustive, given that clinical practice guidelines are not the only source for the identification of areas of low value care.[44] Additional low value care practices can be identified in specific contexts and can include, for example, over-testing of hemoglobin A1c in patients with controlled type 2 diabetes and routine treatment of subclinical hypothyroidism in older patients, as previously mentioned.[21, 45]

Table 1.

Potential areas of low value care in endocrinology

	Recommendation	Strength/Quality of Evidence/Process
ATA	If a thyroid nodule nodule is benign on cytology, further immediate diagnostic studies or treatment are not required.	Strong/high quality
ATA	Routine TSH suppression therapy for benign thyroid nodules in iodine sufficient populations is not recommended. Though modest responses to therapy can be detected, the potential harm outweighs benefit for most patients.	Strong/high quality
ATA	If RAI remnant ablation is performed after total thyroidectomy for ATA low-risk thyroid cancer or intermediate-risk disease with lower risk features (i.e., low-volume central neck nodal metastases with no other known gross residual disease or any other adverse features), a low administered activity of approximately 30 mCi is generally favored over higher administered activities.	Strong/high quality
ATA	We strongly recommend against the use of levothyroxine treatment in patients who have nonspecific symptoms and normal biochemical indices of thyroid function because no role exists for use of levothyroxine in this situation.	Strong/high quality
ENDO	In pregnant patients with prolactinomas, we recommend against performing serum prolactin measurements during pregnancy.	Strong/high quality
ENDO	We recommend against dynamic testing of prolactin secretion for the diagnosis of hyperprolactinemia.	Strong/high quality
ENDO	We recommend screening for vitamin D deficiency in individuals at risk for deficiency. We do not recommend population screening for vitamin D deficiency in individuals who are not at risk.	Strong/high quality
ENDO	We recommend against using the serum 1,25-dihydroxyvitamin D assay for this purpose and are in favor of using it only in monitoring certain conditions, such as acquired and inherited disorders of vitamin D and phosphate metabolism.	Strong/high quality
USPSTF	Concludes with moderate certainty that daily supplementation with 400 IU or less of vitamin D and 1000 mg or less of calcium has no net benefit for the primary prevention of fractures in community-dwelling, postmenopausal women.	The USPSTF recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits.
USPSTF	Concludes with moderate certainty that screening for thyroid cancer in asymptomatic persons results in harms that outweigh the benefits.	The USPSTF recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits.
USPSTF	Concludes with moderate certainty that the use of combined estrogen and progestin has no net benefit for the primary prevention of chronic conditions in most postmenopausal women with an intact uterus. Concludes with moderate certainty that the use of estrogen alone has no net benefit for the primary prevention of chronic conditions in most postmenopausal women who have had a hysterectomy.	The USPSTF recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits.
ENDO/CW	Don’t routinely order a thyroid ultrasound in patients with abnormal thyroid function tests if there is no palpable abnormality of the thyroid gland.	*
ENDO/CW	Don’t routinely measure 1,25-dihydroxyvitamin D unless the patient has hypercalcemia or decreased kidney function.	*
ENDO/CW	Avoid routine multiple daily self-glucose monitoring in adults with stable type 2 diabetes on agents that do not cause hypoglycemia.	*
ENDO/CW	Don’t order a total or free T3 level when assessing levothyroxine dose in hypothyroid patients.	*
ENDO/CW	Don’t prescribe testosterone therapy unless there is biochemical evidence of testosterone deficiency.	*
Kerr et al	Don’t prescribe testosterone to men with erectile dysfunction who have normal testosterone levels.	Multi-step process (guidelines review, evidence synthesis and consultations with stakeholders)
Kerr et al	Don’t routinely repeat DEXA scans more often than once every two years.
Kerr et al	Don’t use DEXA screening for osteoporosis in women younger than 65 or men younger than 70 with no risk factors.
Kerr et al	Avoid using medications other than metformin to achieve hemoglobin A1c <7.5% in most older adults; moderate control is generally better.
Kerr et al	Don’t perform population-based screening for 25-hydroxyvitamin vitamin D deficiency.

ATA, American Thyroid Association; RAI, radioactive iodine; TSH, thyroid stimulating hormone; DEXA, dual energy x-ray absorptiometry; ENDO, Endocrine Society; CW, Choosing Wisely; USPSTF, U.S. Preventive Services Task Force.

^*Developed as part of the CW campaign a task force that identified procedures that should only be used in specific circumstances, evaluated their evidence, value of the recommendation and potential cost saving, followed by a vote to identify their top five recommendations.

Table 2.

Selected areas of low value care in endocrinology – evidence, impact and potential action.

Clinical Situation	Evidence	Prevalence	Possible Harms	Potential Actions	Potential Levels of Intervention
Tight glycemic control in older patients with diabetes mellitus type 2	Ineffective, contradicted (lack of improvement in patient important outcomes)	High	High (hypoglycemia, treatment burden)	Replace HbA1c target	Multi-level: patient, clinician, healthcare system, society For example, at the clinician level – education about HbA1c targets for older patients and audit/feedback based on the proportion of patients with lower HbA1c and hypoglycemia
Treatment of subclinical hypothyroidism in older patients	Ineffective, contradicted (lack of improvement in patient important outcomes)	High	High (hyperthyroidism, treatment burden)	Restrict routine use of levothyroxine therapy	Multi-level: patient, clinician, healthcare system, society For example, at the patient level – education clarifying lack of benefits for patient important outcomes and risks of overtreatment
Screening for thyroid cancer	Ineffective (lack of improvement in patient important outcomes)	High	High (overdiagnosis and overtreatment of thyroid cancer, side effects of treatment, costs, potential lifelong levothyroxine treatment)	Remove screening thyroid ultrasound	Multi-level: patient, clinician, healthcare system, society For example, at the healthcare system level – limiting reimbursement for thyroid ultrasounds performed for thyroid cancer screening in patients without risk factors
Routine monitoring of benign thyroid nodules	Ineffective (lack of improvement in patient important outcomes)	High	Moderate (opportunity cost due to follow up evaluation, medical expenses – ultrasound, repeat biopsy)	Reduce frequency of follow up	Multi-level: patient, clinician, healthcare system, society For example, at the patient and clinician levels – conversation aids that can help evaluate different follow up strategies
Testosterone therapy in patients without hypogonadism	Ineffective, contradicted (lack of improvement in patient important outcomes)	High	High (frequent side effects, opportunity cost, medical expenses)	Remove routine testosterone therapy	Multi-level: patient, clinician, healthcare system, society For example, at the societal level – national campaigns that seek to disseminate information related to risks and lack of benefit of testosterone therapy in patients without hypogonadism

Evidence: ineffective (does not work), contradicted (new evidence shows the practice does not work), mixed (conflicted results), untested (lack of clinical evidence).

Action: reduce (offer less frequently), replace (substituting with a different one), remove (cease the practice entirely), restrict (narrowing the target population).

Levels of intervention: due to the complexity associated with de-implementing low value care, multi-level interventions are likely required in order to facilitate the process of de-implementation. Evaluation of the context and drivers for these practices can help understand which de-implementation strategies and at what level are more likely to result in successful and sustained de-implementation.

HbA1c, hemoglobin A1c.

Despite evidence of low value care for the management of highly prevalent conditions (e.g., diabetes, thyroid nodules, hypothyroidism, osteoporosis), most commonly, research studies in endocrinology have been limited to identifying and prioritizing low value care practices without developing strategies to change practice, which highlights an important clinical and research need in endocrinology: moving towards active de-implementation of low value care.

2. Facilitate the process of de-implementation

To facilitate the process of de-implementation, researchers should understand the factors that motivate and maintain low value care practices. Once these factors are identified, de-implementation strategies are selected based on theories that guide behavior change and contextual knowledge of the local barriers/facilitators.[27] Hence, understanding the factors related to: 1) the medical practice to be de-implemented, 2) patients, 3) clinicians, and 4) the organization is pivotal when addressing inappropriate health practices. This is important given that the barriers to reducing overuse are complex and occur at multiple levels, resulting in the need for multilevel complex strategies supporting de-implementation. [6, 27, 46] Broadly, authors identified clinical evidence, eminency (guidelines) and economics (e.g., reimbursement, incentives) as important factors affecting de-implementation success.[47]

The framework by Morgan et al, although designed to conceptualize interventions to reduce medical overuse, can be used to understand factors driving low value care.[48] In this framework, the patient-clinician interaction takes center place and is influenced by: 1) the culture of professional medicine (i.e., clinician attitudes and beliefs), 2) the culture of healthcare consumption (patient factors and experiences), and 3) the practice environment. Each of these variables represents a potential driver for overuse and for intervention to address the overuse.[48] For example, consider the inappropriate use of thyroid ultrasound in clinical practice. The USPSTF recommends against routine screening for thyroid cancer using thyroid ultrasound and the Choosing Wisely campaign cautions against the use of thyroid ultrasound in patients with abnormal thyroid function test but without palpable abnormality.[10, 42] However, almost 50% of thyroid ultrasounds performed at a tertiary center fell outside these recommendations.[49] Moreover, a survey of approximately 600 clinicians found that patient request, in addition, to abnormal thyroid function and abnormal thyroid antibody testing were considered reasons for ordering a thyroid ultrasound.[50] In this situation, patients may be anxious and have incorrect expectations related to the value of medical care (e.g., better outcomes in case of early diagnosis of thyroid cancer, understanding the etiology of their symptoms as a result of thyroid ultrasound). Clinicians may be cautious of de-implementing care based on previous experiences and fear of litigation related to concern for negative evaluation by patients or missed cancer diagnosis. Additionally, a study that evaluated drivers for low value testing of vitamin D found that although general practitioners might be aware of the potential lack of benefit, they prefer to avoid conflict with patients and support their relationship.[51] Finally, organizations might have different climates in terms of adopting and supporting de-implementation strategies. For example, in the case of inappropriate thyroid ultrasound use, in some organizations, significant revenue may be derived from thyroid ultrasound.[27, 48]

In response to these challenges, multilevel de-implementation strategies might be needed and could include interventions to: decrease patient concerns and fears of not receiving a medical intervention (thyroid ultrasound), decrease clinician concerns with potential litigation, and evaluate allocation of resources and sources of revenue for organizations that profit from low value care. The culture of healthcare consumption could be influenced by public education (e.g., harms of thyroid cancer overdiagnosis and benefits of active surveillance of small and low risk cases of thyroid cancer, lack of correlation between ultrasound findings and systemic non-specific symptoms); patients might receive education about the comparative value and harms of different interventions; and the patient and clinician interaction can be supported by shared decision making tools that help both patients understand when thyroid cancer screening might be indicated and facilitate patient-clinician discussion of management strategies for non-specific symptoms. Practice changes that align clinician incentives with adequate care and regulatory action that supports these goals are complex but potential areas to be addressed in de-implementation strategies.[27, 48] Supporting the framework by Morgan et al and the importance of the patient and clinician interaction, a systematic review and meta-analysis found that interventions that aim to reduce low value care by engaging patients in the patient clinician interaction, by providing educational materials, or supporting shared decision making led to reductions in low value care.[52]

As discussed, once the factors that drive the use of low value care practice are elucidated, the next step involves selecting de-implementation strategies that can address those factors. A systematic review evaluating strategies to reduce low value care, identified nine different de-implementation strategies.[46] Studies reporting successful reduction of low value care used strategies such as clinical decision support, clinician education, patient education, and multicomponent interventions.[46] Other interventions included: cost sharing (i.e., shifting cost of low value care to the patient), provider report cards (giving information to the patient related to the use of low value care services by the provider), pay for performance (i.e., providing financial incentives to clinicians), insurer restrictions (i.e., limiting reimbursement of low value care), risk sharing, and provider feedback.[46]

3. Evaluate the outcomes of de-implementation, including sustainability

The acceptability and appropriateness of de-implementing a medical practice are important outcomes that should be considered early in the de-implementation process. If stakeholders do not perceive a practice as appropriate for de-implementation, the process of de-adoption might be more challenging compared to interventions for which de-implementation is perceived as acceptable and appropriate.[53] In the example of inappropriate thyroid ultrasound, clinicians might find it easier to reduce the use of thyroid ultrasound to evaluate abnormal thyroid function tests or antibody results given clinical evidence supporting the lack of benefit; but less acceptable to reduce its use in the scenario where a patient requests it, if this is perceived as a potential litigation risk or a strain in the patient-clinician relationship.

Although cost saving is commonly considered a positive outcome in the de-implementation of low value care, it is important to examine outcomes beyond immediate savings. For example, low value care practices that are not costly require long-term assessments to demonstrate cost-effectiveness. On the other hand, de-implementing costly strategies that require specialized staff, expertise and infrastructure, might have negative immediate economic consequences for organizations.[53] In the case of de-implementing inappropriate thyroid ultrasound use, avoiding the downstream healthcare utilization if a thyroid nodule is found (e.g., follow up ultrasound, thyroid biopsy, surgery) is likely to result in overall healthcare cost savings with reduced revenue for organizations.

Lastly, de-implementation is an iterative and dynamic process, even if initially successful, researchers should evaluate its penetration – i.e., the extent to which a practice is discontinued within a service setting and its subsystems – and its sustainability – i.e., the extent to which a practice’s discontinuation is maintained.[53] In the case of inappropriate use of thyroid ultrasound, this refers to the number of clinics and clinicians within a specific system that de-implement inappropriate use of thyroid ultrasound and whether these changes are maintained over time (i.e., after funding for the de-implementation project is completed).

An important aspect of de-implementation science is the possibility of downstream, unintended consequences. For example, patients might experience increased distrust in the medical system, if a previously recommended intervention is no longer recommended (e.g., routine total thyroidectomy for all patients with thyroid cancer) and clinicians might increase the use of other medical interventions in order to compensate for the intervention that was de-implemented (e.g., additional blood tests or imaging tests if thyroid ultrasound is not ordered as a response to a patient request).[27, 54]

De-implementation science in endocrinology: a step forward

We have identified several low value care practices in endocrinology that are addressed in clinical practice guidelines. However, clinical practice guideline recommendations alone are not sufficient to change endocrine practice.[7, 36, 47] In addition to the example of inappropriate thyroid ultrasound for which passive de-implementation has not occurred, evidence suggests the same is true for other clinical situations such as less stringent hemoglobin A1c targets in older patients with type 2 diabetes or aggressive treatment for patients with thyroid cancer, where although some improvement in practice is noted, further efforts are needed to reduce low value care. [40, 49, 55] A recent study evaluated the impact of a payment policy change compared with the effect of Choosing Wisely recommendations regarding the use of two low value care labs (general vitamin D testing and triiodothyronine levels) in three different healthcare systems. In Ontario, Canada, elimination of reimbursement for low value vitamin D screening was associated with 93% relative reduction of screening. However, Choosing Wisely guidelines resulted in a more modest reduction in vitamin D testing; 5% in Canada, 14% for the US Veterans Health Administration, and 14% for a US employer-sponsored insurance. There were no significant changes for testing triiodothyronine levels after the Choosing Wisely recommendations, except for a minor increase in testing for the US employer-sponsored insurance.[56]

This urgent need to actively work towards de-implementing low value care is not unique to endocrinology. A portfolio analysis of funded research grants by the National Institutes of Health and the Agency for Healthcare Research and Quality (2000-2017) found that only 3.4% (N=20) focused on understanding factors associated with de-implementation (70%) or testing strategies to facilitate this process (75%). None focused directly on the aforementioned areas of low value care in endocrinology, although one study addressed hormone replacement therapy in the post women’s health initiative era. Analysis of the research portfolio of other funding agencies can help generalize these findings (e.g., Veteran Affairs system, Patient-Centered Outcomes Research Institute). [7]

In order to move the field forward and decrease low value care in endocrinology, effort is needed to 1) increase awareness, interest and familiarity with de-implementation science among endocrine clinicians and researchers, 2) foster collaborations among different stakeholders and policy makers, that can help identify (guidelines) and support de-implementation in practice (policy), and 3) increase funding opportunities for such work.[7]

Conclusion

Low value care practices are present in highly prevalent medical conditions within endocrinology, exposing patients to ineffective and potentially harmful care. Passive de-implementation is unlikely to occur. Increased awareness, familiarity, and application of de-implementation science methods are urgently needed in endocrinology to move past the initial step of identifying low value care towards better understanding the drivers of low value care practices and evaluation of de-implementation strategies to decrease their use.