1. What can we learn from serious clinical complaints Graham Neale Imperial College

2. 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..

3. But how does the public see medical mistakes? Much influenced by the legal process

4. 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

5. 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’

6. Claims recorded by NHSLA (to March 2008)

7. Data from Weeks WB et al J Law Med Ethics 2001; 29: 335-45

8. 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

9. 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)

10. 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.

11. 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?

12. Diagnosis is underpinned by data collection and decision-making

13. Misdiagnosis: “No fault” errors PresentationRelated dataExample SilentNone available Pulmonary emboli (in the elderly or very sick) AtypicalHiddenEarly meningitis Non-compliant patientData not revealedVomiting and pregnancy

14. Misdiagnosis: System errors SystemDefectExample Interpretation of data Interpretation radiographs; ECGs Missed fractures Training (supervision) Quality of senior input (ward rounds and OP clinics) Epilepsy over- diagnosed by 20% Follow-up/handover Abnormal test missedAnti-coagulation

15. But most diagnostic errors appear to be cognitive or behavioural (Croskerry et al Acad. Med 2003; 78: 775-80)

16. The 2 systems of decision-making CharacteristicType 1 (intuitive) Type 2 (analytic) CognitiveHeuristicSystematic AwarenessLowHigh ProcessingParallelSerial AutomaticityHighLow Rate /EffortFast/ LowSlow/High ErrorsNormative distributionFew but significant Scientific rigorLowHigh

17. 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)

19. 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,

20. The dangers of hospital organisational structure Hierarchical leadership – the apprentice-bias Premature closure

21. 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”

22. 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

23. The patient has ‘Briquet’s syndrome - somatisation

24. 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

25. 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

26. 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 ***********************

27. 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)

28. Cognitive dispositions in action Multiple alternatives – none really satisfied Sutton’s slip – considered only the obvious Yin-yang out – nothing more to do

29. Never forget the effect of drugs ‘Google’ Capecitabine and chest pain

30. 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 pagesSimilar pages by N Frickhofen - 2002 – Cited by 56 - Related articles - All 7 versionsCited by 56Related articlesAll 7 versions

31. An 86 years’ old female with constipation and urinary frequency

32. Mrs EC aged 86y SHO notes at 1230h PC1. Constipation 2. Urinary problems HPC 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. PMHStaghorn calculus Meds Trimethoprim Digoxin Lorazepam Hypertension Na docusate Frusemide Lansoprazole Hypothyroidism Senna Spironolactone Glipizide NIDDM Fe sulphate Amlodipine Paracetamol AF l-Thyroxine Dipyridamole (NKDA) No drug allergy

33. SHO examination

34. 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 -)

37. Cognitive dispositions to respond (CDRs) that affected assessment

38. 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

39. Instead of impression suggest Analysis: Diagnostic issuesPlan SepsisHunt – clinical examination; scanning; blood culture Urinary tract infectionCheck MSU past and present Renal failureFollow progress (hydrate) MedicationsDiscontinue digoxin Cardiac diseaseECG. cardiologist

40. Diagnostic issuesPlanAction by SepsisUrgent hunt – clinical examination; scanning; blood culture SHO/registrar (resident) Urinary tract infectionCheck MSU past and present Ward doctor Renal failureFollow 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

41. CDRs that appeared to underlie misdiagnoses ( unvalidated data from a pilot study) Being too easily satisfied 14 Minimising the serious11 Playing the odds 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 6 Failing to think ‘outside the box’ 6 Failing to elicit all the information 5

42. 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

44. Over to medical team

45. CDRs that affected medical assessment Diagnostic momentum Confirmation bias

46. Day 2

47. CDRs that affected ‘post-take’ assessment diagnostic momentum ‘silo-thinking’ – economy, utility, efficiency no time for ‘complex unpacking’

49. CDRs that affected assessment by FY1 Unable to think outside the box Failure to get help Lack of commitment/supervision by senior staff

50. Day 3

51. 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

52. Day 4

53. 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

54. Day 4 pm

56. Presented as a difficult case But was it? What did the GP think?

57. Walk-in clinic referral

58. 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

59. Transcript from case record (2) OE: Well, undistressed T36.4, BP126/66, SaO 2 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

60. 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

61. 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

62. 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

63. 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

64. 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 incorrectly60% Problems with organisation, systems, communication etc were relatively rare

65. 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

66. 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.