Objective: List several methods to identify low-value and ineffective medical care

Prasad, Vinay, MD, MPH

English

Lehigh Valley Health Network: LVHN Scholarly Works

How to Identify Low Value and Ineffective Medical CareVinay Prasad, MD MPHAssociate Professor of MedicineDivision of Hematology-OncologyDepartment of Public Health and Preventive MedicineSenior Scholar in the Center for EthicsOregon Health & Science UniversityDisclosureFunding:@vpplenaryseshDisclosure• Some of this talk is controversial.  • It is not my purpose to disparage any particular practice• Broad patterns of medical progress/ innovation/ evidence (& hijacked) and missteps in medicineWhat is Medical Reversal?Often in medicine new practices replace older ones.H2 -> PPIMOMP -> MOPP -> ABVDStreptokinase -> TPA -> PCA BM stent/-> drug elutingWhat is Medical Reversal?Many other times, something we had been doing is found to be no better or worse than a prior or lesser standard of care (incd. doing nothing)Routine use of Swan Ganz for monitoring ICU patientsRoutine HT for post-menopausal womenRoutine PCA for stable anginaWhat is Medical Reversal?Is much more like this….Definition of Medical ReversalA large, well done study; typically RCT (with better blinding/controls/ power/ endpoints aka less bias) contradicts current medical practiceTalk outline• Select examples of reversal• Frequency estimates• Harms• Origins• Solutions• Objections• What will EBM look like in the age of recognition of Medical ReversalTalk outline• Select examples of reversal• Frequency estimates• Harms• Origins• Solutions• Objections• What will EBM look like in the age of recognition of Medical ReversalThough common practice, ASTRAL showed no benefit for stenting over optimal medical management for RASNEJM 2009Steroid injection for spinal stenosisTalk outline• Select examples of reversal• Frequency estimates• Harms• Origins• Solutions• Objections• What will EBM look like in the age of recognition of Medical ReversalOur own estimateHow often does it happen?How often does it happen?How often does it happen?How often does it happen?How often does it happen?How often does it happen?We detail all 146 Reversals in the Supplementary AppendixReversals include• Medications/ Procedures/ Devices/ Surgeries/ Screening tests/ OTC medications/ Vitamins/ Supplements/ Treatment algorithms (P2y12 testing)/ Diagnostic instruments (Swan Ganz)/ Systems interventions/ Quality and performance measures• In short, every corner of health careTalk outline• Select examples of reversal• Frequency estimates• Harms• Origins• Solutions• Objections• What will EBM look like in the age of recognition of Medical ReversalWhat are the harms of reversal• Harms are threefold:• People who undergo the practice during the years it fell in favor• People who undergo the practice during the lag time before it falls out of favorTen years of inertia• Loss of trust in medical systemWhat are the harms of reversal• Harms are threefold:• People who undergo the practice during the years it fell in favor• People who undergo the practice during the lag time before it falls out of favorTen years of inertia• Loss of trust in medical systemWhy is reversal problematic?• No benefit to patients in years it was in favor• Lag time to reversal• Loss of trust in medical systemWhy is reversal problematic?• No benefit to patients in years it was in favor• Lag time to reversal• Loss of trust in medical system (mammography)Talk outline• Select examples of reversal• Frequency estimates• Harms• Origins• Solutions• Objections• What will EBM look like in the age of recognition of Medical ReversalWhy does Reversal happen?• We adopted something based on inadequate & biased studies (w/o definitive trials ongoing or forthcoming)– Pathophysiology alone– Pathophysiology plus anecdotal evidence– Epidemiological evidence (with residual confounding)– Historical controlled evidence– Randomized trials• Inappropriate controls (too young/ non representative)• Inappropriate dosing/ comparators/ concom. medications• Single center• Drug run periods• Inappropriate endpoints (surrogates)• Early termination• Selective reporting/ publication bias– Meta-analysis – based on caliber of included studies & completenessPragmaticSham controls neededfor subjective endpoints• Meniscectomy for knee OA• Debridement for knee OA• RV pacing for HOCM• Vertebroplasty• Lumbar steroid injections• PCA for stable angina (IMA ligation, Cobb)Drug run in periods• Test a different question:  whether it is better to stay on Entresto or switch to enalapril after exposure to both agents for unequal time• Y = Mortality• X1 = Vitamin E exposure• X2 = Age• X3 = Sex• X4 = Race• Y = Mortality• X1 = Vitamin E exposure• X2 = Age• X3 = Sex• X4 = Race• X5 = Income• Y = Mortality• X1 = Vitamin E exposure• X2 = Age• X3 = Sex• X4 = Race• X5 = Income• X6 = Smoking• Y = Mortality• X1 = Vitamin E exposure• X2 = Age• X3 = Sex• X4 = Income• X5 = Smoking• X6 = body mass index (BMI), hypertension, diabetes, cholesterol, alcohol consumption, education, family history of heart disease, heart disease, any cancer, physical activity) and race/ethnicityObservational/ Epidemiology studies can say anythingHazard RatioSignificanceIoannidis, PatelThe Media doesn’t helpRandomized trialsObservational trialsTalk outline• Select examples of reversal• Frequency estimates• Harms• Origins• Solutions• Objections• What will EBM look like in the age of recognition of Medical ReversalSolutions*• New costly technologies that are being introduced to health systems are ideal for testing in RCTsSolutions*• New costly technologies that are being introduced to health systems are ideal for testing in RCTs• We need to prioritize unproven medical practice (Value of information) and run a large, non-conflicted trials agendaSolutions*• New costly technologies that are being introduced to health systems are ideal for testing in RCTs• We need to prioritize unproven medical practice (Value of information) and run a large, non-conflicted trials agenda• Design and conduct of clinical trials should move to third party agencyTalk outline• Select examples of reversal• Frequency estimates• Harms• Origins• Solutions• Objections• What will EBM look like in the age of recognition of Medical ReversalWhat about RCTs of parachutesWhat about RCTs of parachutes• Two limits of the analogy• 1.  A single clear etiology (BCR-ABL)– Trauma –• 2.  A  huge effect sizePrior “parachutes” were no such thingMost medical practices don’t have large treatment effectsSome advances have been tested without RCTFinal thought• History has taught us that the arc of medicine bends towards higher standards of evidenceQuestionsPurpose of this talk is not to litigate any particular practiceBut to speak broadly about patterns of medical progress and missteps.If you liked the talk, check out the book• @vpplenarysesh

How to Identify Low Value and Ineffective Medical Care

https://scholarlyworks.lvhn.org/cgi/viewcontent.cgi?article=1010&context=fleming-infectious-disease-symposium

How to Identify Low Value and Ineffective Medical Care

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