Transcript Slide 1
What can we learn from serious clinical complaints Graham Neale Imperial College Errors in hospital care. Hospitals are not High Reliability Organisations The accepted mantra for reducing adverse events: Active failures are committed by those in direct contact with the patient – very difficult to modify – sanctions and exhortations have little effect. So use root cause analysis to define the underlying causes of error Identify latent failures in organisational and managerial spheres and concentrate on avoiding these. . But how does the public see medical mistakes? Much influenced by the legal process The legal process – Tort negligence (from L. torquere – wrong, twisted) The tort of negligence has developed this century largely as a result of the judgement: Donoghue v Stevenson (1928). May Donoghue, a single mother of modest means but of much determination, was enjoying a ‘Scotsman ice-cream float’. The café owner poured on the ice-cream ginger beer from a brown opaque bottle labelled Stevenson’s of Paisley. May took a drink and then saw the partly decomposed remains of a snail. She was distressed and shocked. The judge articulated the rules that we live by today The legal process – Tort negligence • The defendant owed a duty of care to the claimant • That duty was breached • The breach caused harm In medical practice we need to ask in what way, how and why was that ‘duty breached’ Specialty im ar y e 164 rs in g P) (G th al 422 Nu Ca r He 449 Pr e nc 752 Am bu la vic es tS er ol og y 774 po r Pa th gy sia 1,121 Pu bl ic lS up ed ica st he al th He cy e 1,210 Ra di ol o An ae ta l ge n Em er 2,000 Pa ra m & ici n gy lo y 6,000 /M en sy ch ol en t ec o M ed G yn a 8,000 /P hi at ry & Su rg er 10,000 Ac cid tri cs 18,000 Ps yc bs te O Number of Claims Claims recorded by NHSLA (to March 2008) 20,000 17,817 16,000 14,000 12,000 9,477 7,920 5,056 4,000 0 149 93 Tr ea tm en t Su rg er y D ia gn os is M ed ic at io Ad n m in is tra ti v e M on i to In rin tra g ve no us flu id An ae st he sia Ps yc hi at ry Eq ui R pm is en k m t an ag em en t Tort Claims VHA 2000 1800 1600 1400 1200 1000 800 600 400 200 0 Data from Weeks WB et al J Law Med Ethics 2001; 29: 335-45 Some background data Diagnostic errors are a significant problem (Harvard study) Diagnostic error (14%) > Medication error (9%) Misdiagnosis - carries a worse outcome (serious 47%) than medication error (serious 14%) Diagnostic errors more likely to be unrecognized or unreported Example cerebrovascular accidents – 9% missed initially – and precursor event events missed in 40% (Ann Neurol 2008; 64(suppl 12) S17 – S18) Causation of misdiagnosis has been little studied In To Err is Human diagnostic error mentioned twice, medication error 70 times In 93 AHRQ-funded studies only one addressed misdiagnosis Breakdowns of process in diagnostic error or delay (Gandhi TK et al Misdiagnosis in the ambulatory setting: A study of closed malpractice claims) (Ann Intern Med 2006; 145: 488-96) 120 100 60 40 20 0 Po or ju La ck d gm of en La t v ck ig ila of nc kn ow e le Po dg or e co m m un ica tio n Po or su pe rv is O io ve rw n or In k te rru ed pt io ns Fa t ig ue Pa tie nt -r el at ed % 80 Diagnosis is one aspect of human error where the final hole in the ‘Swiss cheese’ model cannot be easily protected Diagnostic errors – the next frontier for patient safety Newman-Toker DE and Pronovost PJ (Johns Hopkins Medical School, Baltimore) JAMA 2009; 301: 1060-2. Can we explore the diagnostic process more profoundly and make potentially useful recommendations for improvement • Relatively little evidence regarding diagnostic error • Doctors reluctant to discuss • Reporting is limited But an important area for psychologists to consider – can their analyses be applied to diagnostic fault? Diagnosis is underpinned by data collection and decision-making Misdiagnosis: “No fault” errors Presentation Silent Atypical Non-compliant patient Related data Example None available Pulmonary emboli (in the elderly or very sick) Hidden Early meningitis Data not revealed Vomiting and pregnancy Misdiagnosis: System errors System Interpretation of data Defect Interpretation radiographs; Example Missed fractures ECGs Training (supervision) Quality of senior input (ward rounds and OP clinics) Epilepsy overdiagnosed by 20% Follow-up/handover Abnormal test missed Anti-coagulation But most diagnostic errors appear to be cognitive or behavioural (Croskerry et al Acad. Med 2003; 78: 775-80) The 2 systems of decision-making Characteristic Type 1 (intuitive) Type 2 (analytic) Cognitive Heuristic Systematic Awareness Low High Processing Parallel Serial Automaticity High Low Rate /Effort Fast/ Low Slow/High Errors Normative distribution Few but significant Scientific rigor Low High How might the problem of diagnostic errors be addressed? Attempts made to analyse diagnostic errors are anecdotal Data very hard to come by – hidden clinically and by the medico-legal process Here describe a pilot study based on cases sent for advice examining what are described as “cognitive dispositions to respond” (CDRs) (Croskerry describes > 30 CDRs in article in Acad Med 2003; 78: 775-80) Breakdown of 35 claims submitted for advice Diagnosis Management Medication Monitoring Surgery A case of severe headache 31 years’ old woman (39 weeks’ pregnant) woke at midnight with severe headache Seen in A&E at 6am. Started on antibiotics for UTI No cause for headache associated with pregnancy and delivered within 24 hours. Medical registrar diagnosed ‘tension headache’ but queried for CT Over next week recurrent headache especially at night (in the early hours) – requiring opiate analgesia. Occasional vomiting. No neurological signs. Subsequent medical assessment – low grade pyrexia ‘probable viral infection’ Consultant note “Improved. Complete course of antibiotics. CT not indicated” Patient discharged despite persistent symptoms over next 4 days (without mention of headache in discharge note) Headaches and vomiting persisted – then on day 6 grand mal fit CT scan: brain abscess with ventriculitis Neurosurgical intervention – recovered but left with severe mental impairment, The dangers of hospital organisational structure Hierarchical leadership – the apprentice-bias Premature closure A case of abdominal pain Female aged 27 with RUQ pain and mildly disturbed liver function. To physician Palpable liver; normal ultrasound. Diagnosis – hepatic steatosis. Advised re weight To private surgeon. Minimal assessment – need laparoscopy. Gallbladder removed – cholesterolosis Post-operative – persistent severe pain and vomiting. Weight loss 3Kg Surgeon states possible “Median arcuate ligament syndrome (MALS)” Laparoscopy ligament divided with difficulty Symptoms persisted Surgeon states “probably incomplete division of ligament” – so open operation Symptoms worse – now requiring home care and morphine-dependent Surgeon states “probably phrenic nerve involvement” referred to Pain Clinic Pain doctor – “I think that there is a huge psychological element here” Look at past medical history Aged 3 Constipation and severe abdo pain………………………Psychological Aged 9 Headaches and vomiting………………………………….Stress-related Aged 11 Severe pains in legs – cant walk ………………................Not organic Aged 12 Atypical abdo pain – private care…………Normal appendix removed Aged 13 Severe temper tantrums…………………………Child Guidance Clinic Aged 14 Severe leg pain after minor injury…. All sorts of tests for non-existent anterior compartment syndrome Aged 16 Back pain – private care Aged 21 Boy friend killed Subsequently started a small successful business – cheated by partner Aged 25 Depression with suicidal ideation Aged 27 onset of abdominal pains The patient has ‘Briquet’s syndrome somatisation The danger of doctors going it alone • “God” syndrome • Over-confidence bias • Diagnostic momentum Note the importance of past medical history – whose responsibility to maintain the list Atypical chest pain Private patient (female aged 57 years) on treatment with capecitabine for Ca ovary develops odd chest pain. Seen as an emergency by junior doctor from Department of Oncology Transcript from case record (after assessment in A&E) Review No further episodes chest pain History suggestive of GORD But Troponin I = 0.06 and might be PE d/w cardiology who suggest admission Will need repeat troponin I and D-dimer mane Relatives upset regarding length of stay in A&E……………. Admit Have written blood forms for Monday *********************** Progress of patient Patient admitted to Oncology ward Further attack of chest pain at midnight Then very breathless Chaotic management by newly appointed junior doctor and inexperienced nurses Patient died At examination post-mortem – pulmonary oedema – cause uncertain (normal heart) Cognitive dispositions in action • Multiple alternatives – none really satisfied • Sutton’s slip – considered only the obvious • Yin-yang out – nothing more to do Never forget the effect of drugs ‘Google’ Capecitabine and chest pain Clinical case Capecitabine can induce acute coronary syndrome ... took three doses of capecitabine (7500 mg/m. 2 total dose) and12 h after the last ingestion of capecitabine before chest pain developed. ...annonc.oxfordjournals.org/cgi/reprint/13/5/797.pdf – Similar pages by N Frickhofen - 2002 – Cited by 56 - Related articles - All 7 versions An 86 years’ old female with constipation and urinary frequency Mrs EC aged 86y SHO notes at 1230h PC HPC PMH 1. Constipation 2. Urinary problems Treated for UTI one week ago with Trimethoprim Has dull ache lower abdo No burning on PU but frequency – small amounts Bowels last open 4 days ago No vomiting, no nausea. Appetite reduced. Staghorn calculus Hypertension Hypothyroidism NIDDM AF (NKDA) No drug allergy Meds Trimethoprim Na docusate Senna Fe sulphate Digoxin Frusemide Spironolactone Amlodipine l-Thyroxine Lorazepam Lansoprazole Glipizide Paracetamol Dipyridamole SHO examination Investigations and next steps Blood tests Na137 K4.6 U14.0 Cr 224 LFTs normal Alb 43 Glob 36 Amylase 24 CRP 251 Hb 13.2 MCV 93 WCC 20.4 (N 19.1) Plts 344 INR 1.0 X-rays Chest – ectatic aorta Abdo – n.a.d. (see next screen) Reviewed with senior resident: Soft abdo passing wind Urine noted (Bld tr Prot+ Leuk – Nitrites -) Cognitive dispositions to respond (CDRs) that affected assessment CDRs that affected surgeon’s assessment • Value bias – didn’t put worst scenario at top of list • Satisficing – stopped searching • Probably person bias – 86-years’ old – what the hell! And that terrible end-piece – impression – might there be a better method of ending a clinical assessment Instead of impression suggest Analysis: Diagnostic issues Plan Sepsis Hunt – clinical examination; scanning; blood culture Urinary tract infection Check MSU past and present Renal failure Follow progress (hydrate) Medications Discontinue digoxin Cardiac disease ECG. cardiologist Diagnostic issues Plan Action by Sepsis Urgent hunt – clinical examination; scanning; blood culture SHO/registrar (resident) Urinary tract infection Check MSU past and present Ward doctor Renal failure Follow progress to assess cause - hydrate Ward doctor Nurse Medications Check digoxin levels ? Diuretics Stop ferrous sulphate SHO/registrar (resident) Co-morbidities CVS: ECG. Discuss cardiologist NIDDM: keep an eye on blood sugar SHO to arrange Nurses to monitor – TPR BP 6-hourly – contact ward doctor if concerned Registrar to review progress in next half-day CDRs that appeared to underlie misdiagnoses (unvalidated data from a pilot study) • Being too easily satisfied • Minimising the serious • Playing the odds 14 11 8 (take the easier option) • “Silo thinking” 8 (economy, utility, efficiency) • Failing to get help 8 (knowing when one does not know) • Making an inadequate investment 7 (pride/duty) • Allowing diagnostic momentum • Failing to think ‘outside the box’ • Failing to elicit all the information 6 6 5 Misdiagnoses in hospital care: how might they be reduced? • Improve recording and analysing • Hunt for explanations – discuss and look (‘Google’) • Improve supervision– at ward rounds for assessment of unsolved or complex cases of quality of case records • Promote teamwork – regular multi-disciplinary meetings with ‘transformational leadership’ • Teach: Cognitive errors and how to minimise • Promote national learning – Scottish Surgical mortality Study – Work of NCEPOD – Look at the Nordic countries – move away from Tort law Over to medical team CDRs that affected medical assessment Diagnostic momentum Confirmation bias Day 2 CDRs that affected ‘post-take’ assessment diagnostic momentum ‘silo-thinking’ – economy, utility, efficiency no time for ‘complex unpacking’ CDRs that affected assessment by FY1 Unable to think outside the box Failure to get help Lack of commitment/supervision by senior staff Day 3 CDRs on day 3 Framing effect – ARF (acute renal failure) (if the clinicians had checked blood urea would have seen improvement – and what does “looks dry” mean!) Omission bias – clearly thought problem in abdomen (/pelvis) – therefore ultrasound – actually I found that CT was requested and refused because of renal failure (radiologist wouldn’t use contrast!) Investigation bias – easier than examining the patient Day 4 CDRs on day 4 Order effect – listed symptoms not problems Unpacking error – failed to unpack the problems that were shown initially Base rate neglect and omission bias - ignored significance of low BP Sunk cost – invested his pride in spotting that patient still taking digoxin Day 4 pm Presented as a difficult case But was it? What did the GP think? Walk-in clinic referral Transcript from case record (1) 18.30h 67F – Known ovarian Ca PC Chest pain, vomiting HPC This morning onset of a burning retro-sternal pain, similar to indigestion pains that have troubled her before. Went to private clinic for a quick check that was normal. Went home and lay down flat. Awoke with discomfort in chest again - burning in nature and went away after vomiting once. Gaviscon helped. No sweating. No radiation to back or arms Now OK Transcript from case record (2) OE: Well, undistressed T36.4, BP126/66, SaO2 97% R.A. Head and neck normal CVS P reg JVPNE HS I +II +0 No murmurs RS S>N>T. Good BS Abdo No masses. No organomegaly ECG Sinus R at 80/min Flat Ts laterally ?1/2 square ST depression V3 Plan: Bloods, CXR nad, Repeat ECG, Review Transcript from case record (3) Systems: Chest No sputum, SOB, haemoptysis Abdo: No pain, change bowels Neuro: No headache, collapse, LOC PMH: Ovarian Ca. Laparotomy and resection last year 2 cycles chemo. Nil else. No DM/CVA/MI/HTN DH: NKDA. Chemo: Capecitabine SH: Non-smoker. <4 units EtOH per week 22.30 Admitted Oncology ward 00.30 Further attack of pain 20 minutes’ delay in getting medical help – chaos on the ward Became very breathless and died PM: Pulmonary oedema; no PE; patent coronary arteries Treated as a Serious Untoward Incident (SUI) but still no diagnosis Never forget the importance of medications nor the importance of teamwork - all sensitive experienced medical clinicians will remember the times when they were rescued from error by nurses, pharmacists and other care workers Classifying error in surgery (Fabri and Zayas-Castro 2008) Defined a template from literature search and faculty input - validated by expert opinion, paired assessment and national survey Residents reported complications electronically (weekly reminders) – specifically requested to classify by Presence of error Type of error Severity of outcome The data were stripped of personal health information – analyzed over 12 months Classifying error in surgery (Fabri and Zayas-Castro 2008) Results from 9,800 surgical procedures Major complications in 332 (3.4%) – underlying error in 78% Individuals doing the wrong thing 20% Individuals doing right thing incorrectly 60% Problems with organisation, systems, communication etc were relatively rare Misdiagnosis in hospital care: how to reduce? • Make clinicians aware of the biases to which we are all exposed in making decisions • Consider how best to analyse clinical data and record conclusions with the action to be taken • Consider the place of using ‘Google’ in diagnosis e.g. to examine the effect of unusual drugs • Re-structure ward rounds so that the difficult case gets detailed attention – preferably from an experienced clinician who takes day-to-day responsibility • Full review of cases that are slow to resolve– consultants to examine quality of case records (cf Sydney) and possibly re-invent post-mortem assessments • Regular unit meetings and Grand Rounds to face issues of Quality and Safety • National learning e.g. Scottish Surgical Mortality Study; the work of NCEPOD; and build on the way clinical complaints are handled in the Nordic countries. • Value of teamwork – transformational leadership A new starting point Human error, not communication and systems, underlies surgical complications Fabri PJ and Zayas-Castro JL (School of Graduate Medicine, University of South Florida) Surgery 2008; 144: 557-65.