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Quality of Shared Decision Making in Lung Cancer Screening: The Right Process, With the Right Partners, at the Right Time and Place

      Abbreviations and Acronyms:

      CT (computed tomography), LDCT (low-dose computed tomography), PET (positron emission tomography), SDM (shared decision making)
      When lung cancer screening with low-dose computed tomography (LDCT) was added as a Medicare benefit in 2015, a lung cancer screening counseling and shared decision making (SDM) visit before the initial screen was made a condition for reimbursement. It was specified that SDM should involve the use of decision aids and the discussion of benefits and harms of proceeding or not with screening (eg, false-positive findings leading to unnecessary invasive investigations, overdiagnosis, and radiation exposure).
      Centers for Medicare & Medicaid Services (CMS)
      Decision memo for screening for lung cancer with low dose computed tomography (LDCT) (CAG-00439N).
      To be eligible for reimbursement, a clinician (either a physician or a qualified nonphysician practitioner, eg, a physician assistant, nurse practitioner, or clinical nurse specialist) needs to conduct the consultation.
      Shared decision making refers to a process in which a patient and a clinician work together to understand the patient's situation and to determine how best to address it.
      • Kunneman M.
      • Montori V.M.
      • Castaneda-Guarderas A.
      • Hess E.P.
      What is shared decision making? (and what it is not).
      This is especially important when making decisions about investigations or treatments that potentially have major adverse effects for which the benefits and risks have to be carefully weighed against each other and in situations in which there is insufficient scientific evidence to inform decisions. Lung cancer screening is associated with potentially important harms to the patient; in particular, there is a substantial risk of false-positive findings on LDCT (lung nodules that are not cancerous), and investigation of these nodules carries a risk of morbidity and even mortality.
      • Aberle D.R.
      • Adams A.M.
      • Berg C.D.
      • et al.
      Reduced lung-cancer mortality with low-dose computed tomographic screening.
      It is, therefore, essential that patients get an opportunity to deliberate the option of lung cancer screening vs no screening with a health professional, so that they can clarify what is most important to them and be guided in their health care decision by their values.
      There seem to be several advantages to referring patients to specialized lung cancer screening programs for these consultations, including access to specialists' experience and expertise.
      • Powell C.A.
      Counterpoint: should only primary care physicians provide shared decision making services to discuss the risks/benefits of a low dose chest CT for lung cancer screening? no.
      A potential downside is that patients and clinicians who conduct the SDM consultations may interpret referral to the screening counseling and SDM visit as referral to the screening procedure itself and then consider the SDM discussion as a mere formality, a bureaucratic hurdle. That is, on referral, patients may expect to receive the screening test, LDCT, rather than to participate in a process by which the patient and clinician determine together whether screening is an adequate response to the patient's risk of lung cancer given the potential benefits and harms of screening vs not screening. Specialists may also confuse the purpose of referral by assuming that patient attendance means that the patient, once adequately informed, prefers screening. Specialists may, thus, just ascertain coverage eligibility and proceed with an informed consent procedure. Misunderstandings triggered by the referral to specialized screening services may be compounded by conflicts of interest that may arise when the clinicians who are expected to engage in SDM have a stake, sometimes financial, in one of the options, in this case, lung cancer screening.
      The challenges that can emerge from having an SDM consultation at a relatively late point on the patient's clinical pathway, when implicit expectations arising from the referral to a specialist lung cancer screening service have the potential to guide the SDM conversation, are associated with challenges in transitioning care between different health care professionals. Ideally, ensuring coordination and continuity of care when the patient leaves one care setting and moves to another would result in all clinicians who participate in the patient's care having current information about the patient's treatment goals, values and preferences, and health or clinical status. In reality, there are often gaps in information sharing between referring clinicians and specialists, which can lead to misunderstandings. Also, patient preferences are constructed in the process of evaluating the options of screening or not screening and may evolve as patients receive information and are involved in SDM. Thus, preferences may change as patients move across settings and access new information.
      In this context, decision making around lung cancer screening calls for a broader understanding of SDM, one in which SDM acts as an integrative process and the mindset and spirit of SDM spans all encounters with different clinicians. The implementation challenge for such a process would be to ensure that the patient and the health professional take part in SDM with the right information, using the right tools, in the right manner, in the right setting, and at the right time (see Table). The promotion of SDM has focused more on the development and uptake of tools that facilitate SDM and not as much on the quality of the SDM process. To ensure a high-quality SDM service, however, SDM for lung cancer screening must transcend the use of tools and instead broadly meet the six domains of health care quality put forward by the Institute of Medicine: SDM should be safe, effective, patient centered, timely, efficient, and equitable.
      Institute of Medicine (IOM)
      Crossing the Quality Chasm: A New Health System for the 21st Century.
      TableOutline of an Ideal/High-Quality SDM Lung Cancer Screening Process
      a CT = computed tomography; LDCT = low-dose computed tomography; PET = positron emission tomography; SDM = shared decision making.
      Steps of the lung cancer screening journeyParties involvedStatus quo in SDM in lung cancer screening
      b The status quo describes a process with less-than-ideal integration of SDM in the patient's screening journey. We are aware that there are substantial differences between clinicians and institutions, and some might already have adopted an ideal/high-quality SDM process.
      Ideal/high-quality SDMChanges to status quo required to implement ideal/high-quality SDM
      Referral of a person at risk (ie, a “healthy” patient) to a lung cancer screening counseling and SDM visit
      • Patient
      • Referring physician (primary care physician, other physicians in acute or chronic care)
      • +/− patient navigator
      The patient is informed that he or she should be referred for lung cancer screening because he or she is a smoker/former smoker

      Screening is presented as desirable. Potential harms of screening are not mentioned.

      Eligibility for lung cancer screening is often insufficiently assessed (eg, no calculation of pack-years for smoking history, no use of a lung cancer risk calculator)
      The patient and referring physician recognize the patient's elevated risk of lung cancer

      To deal with this risk, the clinician emphasizes that smoking cessation is the most effective way of reducing lung cancer risk. The clinician also reveals the possibility of lung cancer screening. The situation is further clarified using a lung cancer risk calculator.

      If the patient is interested in lung cancer screening and is potentially eligible to participate in the program, the patient can be referred to participate in a conversation about risks and benefits of lung cancer screening with an expert clinician
      Eligibility for lung cancer screening is assessed using a risk calculator

      Being eligible for lung cancer screening is not framed as desirable but as an indicator of high lung cancer risk

      The eligible patient is given a choice to be referred to an expert clinician to explore risks and benefits of lung cancer screening further rather than being told that he or she should have lung cancer screening

      The importance of smoking cessation is emphasized if the patient is still smoking
      Lung cancer screening counseling and SDM visit
      • Patient
      • Clinician with experience in lung cancer screening
      • +/− patient navigator
      Determination of eligibility for lung cancer screening using ≥1 lung cancer risk calculators is at the core of the consultation

      Being eligible for lung cancer screening might be presented as desirable (although it indicates a high risk of lung cancer). If patients are not eligible for screening, they feel like they are missing out on something that would help them.

      If the patient is eligible, it is assumed that screening is the option preferred by the patient. Informed consent is obtained.

      The patient receives information about the risks and benefits of lung cancer screening (eg, brochure, video, slide show)

      The patient is asked whether he or she needs help with smoking cessation; if so, he or she is given informational material/contact details of smoking cessation services
      If the risk of lung cancer is too low, the clinician explains to the patient that screening is not an option because its potential harms would exceed the benefits in people at low lung cancer risk

      If eligible, clinician and patient work together to determine whether lung cancer screening makes intellectual, emotional, and practical sense given the patient's overall personal and medical situation, as well as their informed preferences and values

      A conversation aid, designed to facilitate the conversation between clinician and patient and to support the communication of evidence, is used to support communication about the relative benefits and harms of screening or not using tailored estimates of risk and state-of-the art information design

      The importance of smoking cessation is emphasized. Practical help for smoking cessation (nicotine replacement therapy, etc) is offered.
      Assessment of the patient's eligibility for lung cancer screening is no longer at the core of the consultation

      Clinician and patient engage in a process together to determine whether lung cancer screening is the right option for the patient

      High-quality information about lung cancer screening/a decision aid is used to inform the deliberation process between clinician and patient and is not just independently presented to the patient

      The patient knows that smoking cessation is more effective than lung cancer screening to prevent dying of lung cancer. Practical help for smoking cessation is offered.
      Discussion of the results of lung cancer screening
      • Patient
      • Primary care physician
      • Expert physician (associated with lung cancer screening program)
      • Radiologist
      • Pulmonologist
      • +/− patient navigator
      The radiology report of LDCT recommends further management/follow-up using a predetermined algorithm

      The primary care physician is left alone to implement the recommendations from the algorithm. The algorithm may be purposefully vague such as to suggest a PET/CT scan or tissue sampling depending on the probability of malignancy and comorbidities.

      The patient is informed about investigations planned to assess potentially suspicious nodules further
      An expert clinician associated with the lung cancer screening program reviews the results of the LDCT, including the radiology report, and either advises the primary care physician on further management/follow-up screening (if no major abnormality is found) or schedules a consultation with the patient to discuss possible investigation of a suspicious nodule

      If a nodule looks potentially suspicious for cancer, a pulmonologist and the patient deliberate the pros and cons of different management options (eg, surveillance with serial CT, nonsurgical biopsy, surgical resection) to arrive at a decision about further investigation that aligns with the patient's context, values, and preferences
      Radiology recommendations for lung nodule management based on algorithms are reviewed by an expert clinician who will advise the primary care physician about the follow-up process

      If further investigation of a suspicious finding is potentially indicated, a pulmonologist and the patient engage in a process together to determine the best way to proceed for the patient
      a CT = computed tomography; LDCT = low-dose computed tomography; PET = positron emission tomography; SDM = shared decision making.
      b The status quo describes a process with less-than-ideal integration of SDM in the patient's screening journey. We are aware that there are substantial differences between clinicians and institutions, and some might already have adopted an ideal/high-quality SDM process.
      Delegating SDM to clinicians who are not directly involved in lung cancer screening could mitigate conflicts of interest and associated pro-screening biases. Whether the bias reduction of such delegation justifies excluding clinicians directly involved with the intervention, who may have the most expertise with it, is unclear. Exclusion may not be the best or only approach to address potential specialist bias. Tools for SDM may address potential clinician biases by providing balanced evidence-based information on the pros and cons of a health care intervention and may calibrate patient and clinician expectations. In our experience, however, clinicians who believe that a patient will benefit from an intervention can use these same tools to persuade a patient of its value.
      • Wyatt K.D.
      • Branda M.E.
      • Anderson R.T.
      • et al.
      Peering into the black box: a meta-analysis of how clinicians use decision aids during clinical encounters.
      Because the magnitude of specialist bias (and of potential anti-screening bias among primary care clinicians) and its effect on the uptake of LDCT for lung cancer screening remains unknown, improvements in the quality of SDM will need to be based on evidence about the limitations of existing services and of the referral paths used to access them.
      A systematic review found that patient navigators are an effective intervention to increase uptake of cancer screening and completion of recommended care events.
      • Ali-Faisal S.F.
      • Colella T.J.
      • Medina-Jaudes N.
      • Benz Scott L.
      The effectiveness of patient navigation to improve healthcare utilization outcomes: a meta-analysis of randomized controlled trials.
      Patient navigators could potentially facilitate SDM across the care continuum of lung cancer screening by involving at-risk people in the community at the time when a referral to a lung cancer screening service is considered, after screening, and in the event of recommended further investigation. Models that use these navigators for continuity of SDM across the health system deserve further investigation.
      When we consider SDM as an ongoing process ingrained in clinical decision making, it is also clear that SDM should be used by patients and clinicians to guide the evaluation of suspicious nodules found by screening. Most lung cancer screening programs manage lung nodules found on screening by applying algorithms, although there is substantial uncertainty in the evidence about the relative merits of different strategies. Serial CT, nonsurgical biopsy, and surgical resection all have potential benefits and risks.
      The implementation of SDM to determine with patients how to address the problem of elevated risk of lung cancer—including methods of smoking cessation and lung cancer screening—would benefit from quality evaluation. Given the potential for misunderstood referrals, potential conflicts of interest, medicalization, and low-quality SDM aimed at ascertaining eligibility or obtaining informed consent, ideal SDM, as described previously herein, should be the benchmark for all lung cancer screening programs. Implementation of SDM—with the right patient, the right clinician, using the right tools, at the right time, in the right setting—would benefit from emphasizing effectiveness (using patient-centered evidence-based communication and well-designed SDM encounter tools), equity (using health literacy universal precautions and designing services and SDM tools for inclusion), timeliness (identifying optimal moments in the continuity of care across practice silos to support SDM), and efficiency (focusing the program on patients most likely to benefit from considering screening using SDM rather than on those for whom reimbursement for screening is available). Screening decisions should reflect how patients consider their own risk situation, how screening addresses that risk, when and how to participate in screening, and how to anticipate and address the results. Whether this is already achieved within current lung cancer screening programs is unknown. Yet, SDM stands as a form of care that, when provided with high quality, can contribute to this ideal.

      Supplemental Online Material

      References

        • Centers for Medicare & Medicaid Services (CMS)
        Decision memo for screening for lung cancer with low dose computed tomography (LDCT) (CAG-00439N).
        (Last updated February 5, 2015. Accessed August 9, 2017)
        • Kunneman M.
        • Montori V.M.
        • Castaneda-Guarderas A.
        • Hess E.P.
        What is shared decision making? (and what it is not).
        Acad Emerg Med. 2016; 23: 1320-1324
        • Aberle D.R.
        • Adams A.M.
        • Berg C.D.
        • et al.
        Reduced lung-cancer mortality with low-dose computed tomographic screening.
        N Engl J Med. 2011; 365: 395-409
        • Powell C.A.
        Counterpoint: should only primary care physicians provide shared decision making services to discuss the risks/benefits of a low dose chest CT for lung cancer screening? no.
        Chest. 2017; 151: 1215-1217
        • Institute of Medicine (IOM)
        Crossing the Quality Chasm: A New Health System for the 21st Century.
        National Academy Press, Washington, DC2001
        • Wyatt K.D.
        • Branda M.E.
        • Anderson R.T.
        • et al.
        Peering into the black box: a meta-analysis of how clinicians use decision aids during clinical encounters.
        Implement Sci. 2014; 9: 26
        • Ali-Faisal S.F.
        • Colella T.J.
        • Medina-Jaudes N.
        • Benz Scott L.
        The effectiveness of patient navigation to improve healthcare utilization outcomes: a meta-analysis of randomized controlled trials.
        Patient Educ Couns. 2017; 100: 436-448