Eduovisual
Biostatistics & Population Health
Decision aids and informed consent integration
— Standard informed consent = legal/ethical disclosure of risks, benefits, alternatives, and right to refuse.
— Decision aid = cognitive/affective tool that helps patients deliberate between ≥2 reasonable options when values matter more than evidence alone.
— Preference-sensitive decisions with no single "right" answer: PSA screening, lung cancer LDCT screening, mammography in ages 40–49, AAA screening, statin initiation for primary prevention, anticoagulation in low-CHA₂DS₂-VASc AFib, prenatal aneuploidy screening, end-of-life and code-status discussions, elective joint replacement, bariatric surgery.
— Close trade-offs (e.g., warfarin vs DOAC in valvular vs nonvalvular AFib; surgery vs surveillance in low-risk prostate cancer).
— High-stakes, low-reversibility decisions (mastectomy vs lumpectomy, LVAD, dialysis modality).
Board pearl: If the stem says "low-risk prostate cancer," "PSA screening at 55," or "LDCT in a 60-year-old with 25 pack-years," the next best step is shared decision-making using a decision aid, not "order the test" or "refuse the test."
— Patient asks, "Doctor, what would you do?" or "Is this test/treatment right for me?"
— Two evidence-supported options with comparable outcomes but different side-effect or lifestyle profiles.
— Patient expresses values, fears, or trade-offs (e.g., "I'm worried about incontinence after prostate surgery," "I don't want to be on a blood thinner forever").
— Screening decisions in the gray zone of guidelines (USPSTF Grade C, individualized).
— Older adults weighing screening vs life expectancy (e.g., colon cancer screening age 76–85 = individualize).
— Pregnant patients choosing between cell-free DNA, quad screen, CVS, or amniocentesis.
— Patients with multimorbidity where guideline stacking creates polypharmacy.
— Goals-of-care conversations in advanced cancer, heart failure, dementia.
— Team talk: "We have a choice to make together."
— Option talk: Present options with balanced risks/benefits, ideally with absolute numbers (e.g., per 1,000 patients).
— Decision talk: Elicit patient preferences and arrive at a decision.
— STEMI, sepsis, tension pneumothorax, anaphylaxis → time-critical, evidence-driven; SDM is brief and consent may be implied/emergency.
— Clear guideline-mandated care (e.g., anticoagulation in CHA₂DS₂-VASc ≥2 with no contraindication) → SDM still occurs but doesn't require a formal PDA.
Key distinction: Informed consent is a legal minimum (disclosure + voluntariness + capacity + understanding); shared decision-making with a PDA is a quality standard that operationalizes consent for preference-sensitive care. Step 3 frequently tests recognizing which is being asked.
— Understanding: Can the patient restate the condition, options, risks/benefits?
— Appreciation: Does the patient apply the information to their own situation?
— Reasoning: Can they compare options and articulate trade-offs?
— Choice: Can they communicate a stable choice?
— Sure of myself? Understand information? Risk-benefit ratio clear? Encouragement received?
— Score <4 suggests clinically significant decisional conflict → deploy a PDA.
— Patient oscillates between choices, repeatedly reschedules, expresses regret about prior decisions, asks the same questions across visits, defers entirely to family or clinician without engagement.
— Use teach-back: "In your own words, can you tell me what we just decided and why?"
— Single-item literacy screener: "How confident are you filling out medical forms by yourself?"
— Match PDA format to literacy (pictographs, icon arrays of 100 faces for risk, plain language at 6th-grade level).
— Patients (and clinicians) overestimate benefit when given relative risk reduction; use absolute risk and natural frequencies ("3 out of 100 over 10 years").
Step 3 management: When a 78-year-old with mild dementia refuses a workup, your first step is a formal capacity assessment (not automatic surrogate activation). If capacity is intact for that decision, the refusal stands even if the family disagrees.
— Describes the health condition and all reasonable options, including doing nothing or watchful waiting.
— Presents probabilities of outcomes in balanced, comparable formats (same denominator, same time horizon, both benefits and harms).
— Uses plain language and pictographs where possible.
— Includes a values clarification exercise (e.g., "How important is avoiding a daily medication vs reducing stroke risk?").
— Discloses funding, authorship, conflicts of interest, and update cycle (typically every 2–3 years).
— Is evidence-based, citing systematic reviews or guideline syntheses.
— Required for lung cancer LDCT screening counseling visit and for LAA occlusion (Watchman) procedures to receive reimbursement.
— Industry-sponsored without disclosure, presents only one option favorably, uses only relative risk reductions, omits harms, no update date.
— Icon arrays (100 faces) → best for communicating absolute risk.
— Bar charts → comparing options side-by-side.
— Video testimonials → balanced perspectives from patients who chose each option; must be representative, not cherry-picked.
— Always use absolute risk and natural frequencies.
— Use a consistent denominator ("out of 1,000 people like you").
— Frame both positively and negatively ("90 will survive / 10 will die") to mitigate framing bias.
Board pearl: A PDA that reports only "50% relative risk reduction" without the absolute baseline risk is non-compliant with IPDAS and biases toward intervention.
— Absolute risk reduction (ARR): difference in event rates between groups.
— Number needed to treat (NNT) = 1/ARR: how many patients must be treated for one to benefit.
— Number needed to harm (NNH) = 1/ARI: counterpart for adverse outcomes.
— Relative risk reduction (RRR): ratio; misleading if quoted without baseline risk.
— 10-year ASCVD risk = 10%. Statin reduces relative risk by ~25%.
— ARR = 2.5% over 10 years → NNT = 40 over 10 years to prevent one MI/stroke.
— Communicate as: "Out of 40 people like you taking a statin for 10 years, 1 will avoid a heart attack or stroke; 39 will not see a difference; a few may develop muscle aches or new diabetes."
— ASCVD Pooled Cohort Equations for statin SDM.
— CHA₂DS₂-VASc + HAS-BLED for AFib anticoagulation.
— Gail/Tyrer-Cuzick for breast cancer chemoprevention.
— FRAX for osteoporosis treatment thresholds.
— PLCOm2012 for lung cancer screening eligibility refinement.
— Framing effect: "90% survival" vs "10% mortality" — present both.
— Availability bias: patient knows someone with a bad outcome → acknowledge, then contextualize with population data.
— Anchoring: first number heard dominates; present multiple time horizons.
Key distinction: Informed consent focuses on disclosure of specific procedural risks; risk communication in SDM focuses on comparative outcomes across options, requiring numeracy support, not just a signature.
— High-stakes, preference-sensitive, irreversible (mastectomy, prostatectomy, LVAD, dialysis initiation, gender-affirming surgery): formal PDA + multi-visit SDM + values clarification + often second opinion.
— Moderate-stakes, preference-sensitive (statin for primary prevention, anticoagulation in low-risk AFib, screening colonoscopy vs FIT): brief PDA + single-visit SDM.
— Low-stakes or evidence-mandated (vaccinations per ACIP, antibiotics for confirmed bacterial infection): standard informed consent; SDM acknowledges patient questions but doesn't require formal PDA.
— Emergencies: implied consent or emergency exception; SDM deferred until stabilized.
— Example: Cancer care often requires sequential consents — diagnostic biopsy, staging imaging, treatment modality choice, clinical trial enrollment. Each is a separate informed consent event; the treatment modality decision is where a PDA adds the most value.
— Advance directive / living will → durable power of attorney for healthcare → state-defined hierarchy (typically spouse → adult children → parents → siblings).
— Surrogate must use substituted judgment (what the patient would want) before best interest standard.
— Note options discussed, PDA used (by name and version), patient's values, decision reached, teach-back confirmation, and consent signed.
Step 3 management: A patient with newly diagnosed low-risk prostate cancer asks about treatment. Best next step = schedule a follow-up SDM visit with a decision aid comparing active surveillance, radiation, and prostatectomy — not immediate referral for surgery.
— USPSTF Grade B with SDM. Use ASCVD calculator + decision aid showing NNT, side effects (myalgia 5–10%, new-onset DM ~0.2%/yr, no clinically meaningful cognitive effect).
— Elicit values: pill burden tolerance, family history weighting, prior medication adherence.
— CHA₂DS₂-VASc ≥2 (men) / ≥3 (women) → anticoagulation recommended; score of 1 is the preference-sensitive zone → PDA.
— Compare DOACs (apixaban, rivaroxaban, dabigatran, edoxaban) vs warfarin: bleeding risk (HAS-BLED), reversibility, cost, monitoring, food/drug interactions, renal dosing.
— Values: fear of stroke vs fear of bleeding, willingness to do INR checks, cost.
— Symptomatic women <60 or within 10 yrs of menopause without contraindications → SDM weighing VMS relief vs VTE, breast cancer, stroke risks.
— Comparable efficacy; PDA compares onset, side effects, access, cost, stigma.
— Requires opioid-specific informed consent / treatment agreement: risks of dependence, overdose, naloxone co-prescription, urine drug monitoring, PDMP review. CDC 2022 guideline emphasizes SDM.
— Choice concordant with patient values predicts adherence > clinician-driven choice.
Board pearl: For statin SDM, the testable answer to "What's the next step?" in a 55-year-old with 10-yr ASCVD risk of 9% is shared decision-making discussion, not automatic prescription.
— Capacity (assessed and documented).
— Disclosure: diagnosis, nature of procedure, risks (including rare but serious), benefits, alternatives (including no treatment), prognosis.
— Understanding (teach-back confirmed).
— Voluntariness (no coercion; family pressure noted).
— Authorization (signed consent or documented verbal in emergencies).
— Reasonable patient standard (majority US states): disclose what a reasonable patient would want to know — Step 3 default.
— Reasonable physician standard: what a reasonable physician would disclose.
— Subjective standard: what this patient would want — applied when patient has expressed specific concerns.
— LAA occlusion (Watchman): CMS-qualified PDA required.
— ICD implantation for primary prevention: SDM encounter required by CMS since 2018.
— Lung cancer LDCT screening: SDM visit with PDA required for first scan.
— Bariatric surgery, joint replacement, cardiac surgery: PDAs strongly encouraged.
— Emergency (immediate threat, no surrogate available) — implied consent.
— Therapeutic privilege (rarely upheld; disclosure would cause serious harm).
— Waiver (patient explicitly declines information — document carefully).
— Incompetence (surrogate consents).
CCS pearl: Before any elective procedure on the CCS, order "informed consent" as an explicit action and document risks/benefits/alternatives discussed — failure to do so is a scoring deduction.
— Life expectancy must be integrated. Use ePrognosis or Lee/Schonberg indices for screening decisions in adults >65.
— Cancer screening cessation: USPSTF and AGS recommend stopping mammography, colonoscopy, PSA when life expectancy <10 yrs; PDAs (e.g., "Is screening right for me?" by Schoenborn) operationalize this conversation.
— Capacity is decision-specific — many patients retain capacity for routine decisions but lose it for complex ones (e.g., trial enrollment).
— Use simplified PDAs, larger font, repeat across visits, involve family with patient permission.
— Supported decision-making (preferred over surrogate when feasible): patient retains authority, trusted others help process information.
— Best initiated before capacity loss; revisit at major health transitions (new diagnosis, hospitalization, functional decline).
— Tools: Five Wishes, POLST/MOLST (actionable medical orders, not just preferences), PREPARE for Your Care (online PDA).
— Medicare reimburses ACP discussions (CPT 99497/99498).
— Use STOPP/START criteria + Beers list. Deprescribing is itself a preference-sensitive decision — patients value symptom control, pill burden, longevity differently.
— Affects pharmacotherapy options (e.g., apixaban preferred over dabigatran in CKD 4); PDA must reflect patient-specific drug feasibility.
Step 3 management: An 82-year-old with mild dementia and CHF asks about colonoscopy. Best step: review life expectancy (likely <10 yrs), discuss harms/benefits with a geriatric-tailored decision aid, and support stopping screening if concordant with her values.
— Prenatal aneuploidy screening: cell-free DNA vs quad screen vs combined first-trimester vs diagnostic CVS/amnio. ACOG endorses PDA use; choice depends on values about test accuracy, miscarriage risk (~0.1–0.3% for invasive testing), and what the patient would do with results.
— Mode of delivery: TOLAC vs repeat C-section after prior cesarean — classic PDA scenario.
— GBS prophylaxis, epidural analgesia, induction timing — informed consent with options.
— Assent from children ~7+ yrs alongside parental permission.
— Adolescent confidentiality: most states allow minors to consent independently for contraception, STI testing/treatment, mental health, and substance use treatment — Step 3 favorite.
— Vaccine hesitancy: motivational interviewing + presumptive language ("She's due for her shots today") + decision support if parent declines; document refusal but maintain therapeutic relationship.
— Use qualified medical interpreters (in-person or video) — never family members for substantive decisions (privacy, accuracy, role conflict).
— Translated, culturally adapted PDAs improve equity; English-only tools widen disparities.
— Some cultures favor family-centered decision-making; ask the patient how they want information shared and who should be involved.
— Universal precautions approach: assume limited literacy for everyone; use plain language, teach-back, and visual aids regardless of perceived education.
Board pearl: A teen requests contraception and asks that parents not be told. In nearly all US states, provide confidential care without parental notification; document and code appropriately to protect confidentiality on EOBs.
— Highest after preference-sensitive surgeries done without adequate SDM (prostatectomy, mastectomy, bariatric surgery). PDAs measurably reduce regret.
— Validated tool: Decision Regret Scale.
— Inadequate disclosure (omitting common or serious risks) → battery or negligence claims.
— Coerced consent (signed in pre-op holding after sedation) → invalid.
— Language/literacy mismatch → consent not truly informed even if signed.
— Boilerplate forms without individualized discussion → legally fragile.
— Patient believes research participation is individualized treatment. Mitigation: explicit framing that research aims to generate knowledge, not benefit them personally; emphasize randomization, placebo, and uncertainty.
— If the patient has capacity, the patient decides — family disagreement does not override.
— If capacity is lost, surrogate must use substituted judgment; clinician's role is to facilitate, escalate to ethics consult if intractable.
— Patient refuses recommended care with capacity → respect refusal, document discussion, offer alternatives, leave door open.
— Clinician conscientious objection (e.g., to abortion, MAID) → must disclose, provide referral to non-objecting clinician, never abandon.
— Rushed visits (<15 min) preclude meaningful SDM → use between-visit PDAs, group visits, nurse navigators.
— EHR consent modules that auto-populate without true discussion = high medicolegal risk.
Key distinction: A signed consent form is evidence of, not equivalent to, informed consent. The substantive conversation is the legal and ethical core.
— Intractable disagreement between patient/surrogate and team about goals of care.
— Questions about decisional capacity that aren't resolvable by primary team.
— Surrogate appears to act against patient's known wishes or best interest.
— Requests for non-beneficial or potentially inappropriate treatment ("futility" disputes).
— Conscientious objection conflicts.
— Pediatric cases where parents refuse life-saving treatment (e.g., transfusion in Jehovah's Witness minor) — may require court order.
— Formal capacity evaluation when the primary team is uncertain (psychiatry confirms, but any physician can assess capacity — Step 3 testable).
— Suspected depression or psychosis distorting decision-making.
— Goals-of-care clarification in serious illness.
— Symptom-driven decisional conflict.
— Family meetings around code status and transitions to comfort-focused care.
— Patient leaving AMA with high-risk condition (still requires informed refusal: capacity, risks of leaving, alternatives, return precautions).
— Suspected fraud or coercion in consent.
— Disputes over surrogate authority.
— Child/elder/dependent adult abuse, certain communicable diseases, gunshot wounds, impaired drivers (state-dependent), credible homicidal threats (Tarasoff duty).
Step 3 management: A patient with capacity refuses life-saving transfusion for religious reasons. Best step: confirm capacity, document informed refusal, explore alternatives (cell salvage, erythropoietin), and respect the decision — do not seek court override for a competent adult.
— Informed consent: patient authorizes a specific intervention after disclosure.
— SDM: collaborative process for choosing among options; consent is the endpoint.
— Informed refusal: patient declines after understanding risks; requires same rigor as consent.
— Educational pamphlet describes a condition; PDA presents options + outcomes + values clarification + decision support.
— Capacity: clinical determination, decision-specific, made by any physician.
— Competency: legal determination by a court, global.
— Substituted judgment: what the patient would have wanted (used first when patient previously had capacity).
— Best interest: objective weighing of benefits/burdens (used when patient never had capacity, e.g., young children, or wishes unknown).
— Advance directive: patient-completed, expresses preferences, not directly actionable.
— POLST/MOLST: physician/clinician-signed medical orders, immediately actionable across care settings, for seriously ill patients.
— Autonomy: patient self-determination.
— Paternalism: clinician overrides patient choice for perceived benefit (rarely justified).
— Libertarian paternalism / nudging: default options designed to favor evidence-based care while preserving choice (e.g., opt-out organ donation) — ethically debated.
Board pearl: "Competency" on the wards is loose language. The exam answer for the clinical determination is capacity.
— MI: behavior change technique for ambivalence (smoking, substance use, adherence). Uses OARS (Open questions, Affirmations, Reflections, Summaries) and elicits change talk.
— SDM: option-comparison for preference-sensitive choices.
— Overlap: both honor autonomy; MI may precede SDM (resolve ambivalence, then choose).
— Setting, Perception, Invitation, Knowledge, Emotions, Strategy/summary.
— Distinct from SDM but often precedes it (diagnosis disclosure → treatment decision).
— Elicits prognosis understanding, fears, sources of strength, trade-offs acceptable, family awareness. Feeds into SDM for treatment intensity.
— Verification of patient understanding; component of SDM and consent, not a substitute.
— Microskill: ask what patient knows/wants, tell information in chunks, ask for understanding/reaction.
— Name, Understand, Respect, Support, Explore. Used when emotion blocks decision-making.
— Humility = lifelong self-reflection and openness; competence = static knowledge. Modern framing favors humility.
Key distinction: When the stem says the patient is ambivalent about quitting smoking, the answer is motivational interviewing. When the patient is choosing between two cancer treatments, the answer is shared decision-making with a decision aid.
— Health status change (new diagnosis, hospitalization, functional decline).
— Treatment milestones (5-year mark on bisphosphonates, statin tolerability, AFib bleeding events).
— Life events (retirement, loss of spouse, new caregiver) — may shift values.
— At every hospital discharge, reassess: anticoagulation appropriateness, statin adherence, advance directive status, code status, primary care follow-up.
— Provide plain-language discharge summary + medication reconciliation + teach-back on red-flag symptoms.
— Diabetes A1c targets are preference-sensitive in elderly/multimorbid patients (ADA: <7% standard; 7.5–8% with comorbidities; <8.5% with limited life expectancy).
— HF goal-directed medical therapy uptitration involves SDM around side effects and pill burden.
— Surveillance intensity, fear of recurrence, late effects — all preference-sensitive; survivorship care plans should include SDM checkpoints.
— Annual SDM revisit for influenza, COVID boosters, age-triggered new screens (e.g., AAA at 65 in men who smoked).
— Antidepressant continuation vs taper after remission (typically 6–12 months for first episode) is an SDM moment.
Step 3 management: A 70-year-old with HFrEF on quadruple therapy reports fatigue and lightheadedness. Best step: SDM conversation weighing symptom burden against mortality benefit; consider modest dose reduction with shared agreement, not abrupt discontinuation.
— CollaboRATE (3-item patient-reported measure of SDM effort).
— SDM-Q-9 (patient questionnaire on 9 SDM steps).
— OPTION-5 (observer-rated SDM behaviors).
— Decisional Conflict Scale before/after PDA use.
— Decision Regret Scale at follow-up (3–6 months post-decision).
— 2–4 weeks post-decision for major treatments — check decisional comfort, adherence, side effects.
— 3–6 months — assess regret, outcomes, need to revisit.
— Annually for chronic preference-sensitive therapies (anticoagulation, statins, hormone therapy).
— Options discussed, PDA name/version used, patient values elicited, decision reached, teach-back confirmed, signed consent if applicable.
— Notes should reflect process, not just outcome ("Discussed risks/benefits/alternatives" alone is insufficient).
— Integrate PDAs into EHR workflows (order-set prompts, patient portal pre-visit education).
— Train clinicians in SDM (workshops shown to improve OPTION-5 scores).
— Track utilization for CMS-mandated SDM visits (LDCT, ICD, Watchman) — non-documentation = non-reimbursement.
— Stratify SDM metrics by race, ethnicity, language, insurance to detect disparities; intervene with translated PDAs and patient navigators.
Board pearl: For lung cancer LDCT screening, the SDM visit must be documented as a separate encounter with specific elements (smoking cessation counseling, eligibility review, PDA use) — billed with G0296.
— Autonomy (patient self-determination) — primary in SDM.
— Beneficence / non-maleficence — clinician obligation to recommend, not just present.
— Justice — equitable access to PDAs across literacy, language, socioeconomic strata.
— SDM does not mean withholding professional opinion. After eliciting values, clinician should offer a recommendation framed to patient's priorities — patients explicitly want this.
— Pre-operative sedation already given → consent invalid; obtain before sedation or defer.
— Patient signs in a language they don't read → use qualified interpreter; consent in patient's language.
— Surgeon-of-record substitution ("ghost surgery") → patient must consent to specific operators; substitution without disclosure is battery.
— Unexpected intraoperative findings → extend procedure only if life/limb-threatening; otherwise close, awaken, re-consent.
— Suspected child/elder/dependent adult abuse, certain communicable diseases (TB, syphilis, HIV in many states), gunshot/stab wounds, impaired drivers (state-dependent), Tarasoff duty to warn identifiable third parties of credible threats.
— Handoffs are highest-risk for consent and goals-of-care errors. Use I-PASS (Illness severity, Patient summary, Action list, Situation awareness, Synthesis by receiver).
— Code status must be reconfirmed at every transition (admission, ICU transfer, discharge, hospice).
— IRB oversight, additional protections for vulnerable populations (children, prisoners, pregnant women, cognitively impaired). Therapeutic misconception must be explicitly addressed.
Step 3 management: A patient signs surgical consent, is wheeled into pre-op, receives midazolam, then asks a new question about risks. Best step: defer or reconfirm consent when fully alert — consent obtained under sedation is invalid.
Board pearl: If the stem mentions a 60-year-old with 25 pack-years quit 10 years ago asking about lung screening — eligible (ages 50–80, ≥20 pack-years, quit ≤15 yrs); next step is SDM visit with PDA, then LDCT.
— 55-year-old man asks about PSA screening. PMH unremarkable. → Answer: shared decision-making discussion using a decision aid (not "order PSA," not "do not screen").
— 78-year-old with mild dementia refuses recommended workup for new anemia. → First step: assess decisional capacity (Appelbaum criteria); if intact, respect refusal.
— Comatose patient, no advance directive, daughter and son disagree on intubation. → Use substituted judgment based on prior expressed wishes; if intractable, ethics consult.
— Competent adult with capacity. → Respect refusal, document informed refusal, offer alternatives. Do not seek court override.
— 16-year-old requests STI testing, asks parents not be told. → Provide confidential care (allowed in nearly all states); document carefully.
— Patient signed consent after receiving lorazepam pre-op. → Consent invalid; reconfirm when fully alert.
— Patient speaks only Spanish; family offers to translate consent. → Use qualified medical interpreter, not family.
— Patient discloses spousal abuse of elderly mother. → Report to Adult Protective Services; confidentiality does not apply.
— Psychiatric patient makes credible threat against identifiable person. → Warn intended victim and law enforcement.
— Pharma-sponsored brochure with only RRR and no disclosure → does not meet IPDAS; choose a balanced, evidence-based PDA.
— Eligible patient asks about screening → schedule SDM visit with qualified PDA before ordering LDCT.
Key distinction: Most SDM stems hinge on recognizing the trigger (preference-sensitive, capacity question, refusal, confidentiality) — then matching to the correct ethical/clinical step rather than ordering a test or drug.
Shared decision-making — operationalized through evidence-based decision aids and rigorous informed consent — is the Step 3 default answer whenever a competent patient faces a preference-sensitive choice with comparable evidence-supported options.
Board pearl: When the stem hands you a competent patient at a values-laden crossroads, the answer is almost never "order the test" or "start the drug" — it is shared decision-making with a qualified decision aid, followed by a documented, individualized choice.