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Monitoring clinical performance 100 years of living science Dr Paul Aylin Dr Foster Unit Imperial College [email protected] 8th November 2007 Date • Location of Event Contents •Background •Data sources • Clinical information systems • Routinely collected hospital data •Methods • Casemix adjustment • Analysis and presentation •Interpretation of performance data Florence Nightingale Florence Nightingale Uniform hospital statistics would: “Enable us to ascertain the relative mortality of different hospitals as well as of different diseases and injuries at the same and at different ages, the relative frequency of different diseases and injuries among the classes which enter hospitals in different countries, and in different districts of the same country” Nightingale 1863 Heart operations at the BRI “Inadequate care for one third of children” Harold Shipman Murdered more than 200 patients Final report of the Bristol Inquiry “Bristol was awash with data. There was enough information from the late 1980s onwards to cause questions about mortality rates to be raised both in Bristol and elsewhere had the mindset to do so existed.” Clinical databases Need to collect extensive clinical information to facilitate adequate adjustment for case-mix has contributed to the creation and maintenance of clinical databases A survey of multicentre clinical databases found the existence of 105 such clinical databases in many areas of UK healthcare Black et.al. BMJ 2004 Bristol (Kennedy) Inquiry Report Data were available all the time “From the start of the 1990s a national database existed at the Department of Health (the Hospital Episode Statistics database) which among other things held information about deaths in hospital. It was not recognised as a valuable tool for analysing the performance of hospitals. It is now, belatedly.” Hospital Episode Statistics UK administrative data Electronic record of every inpatient or day case episode of patient care in every NHS (public) hospital 14 million records a year 300 fields of information including • Patient details such as age, sex, address • Diagnosis using ICD10 • Procedures using OPCS4 • Admission method • Discharge method HES regarded as unreliable by many clinicians Comparison of administrative data vs clinical databases Isolated CABG • HES around 10% fewer cases compared to National Cardiac Surgical Database Fifth National Adult Cardiac Surgical Database Report 2003. The Society of Cardiothoracic Surgeons of Great Britain and Ireland. Dendrite Clinical Systems Ltd. Henley-Upon-Thames. 2004. Vascular surgery • HES = 32,242 • National Vascular Database = 8,462 Aylin P; Lees T; Baker S; Prytherch D; Ashley S. (2007) Descriptive study comparing routine hospital administrative data with the Vascular Society of Great Britain and Ireland's National Vascular Database. Eur J Vasc Endovasc Surg 2007;33:461-465 Bowel resection for colorectal cancer • HES 2001/2 = 16,346 • ACPGBI 2001/2 = 7,635 • ACPGBI database, 39% of patients had missing data for the risk factors Garout M, Tilney H, Aylin, P. Comparison of administrative data with the Association of Coloproctology of Great Britain and Ireland (ACPGBI) colorectal cancer database. International Journal of Colorectal Disease 2007. Cost • Administrative data £1 per record • Clinical databases range from £10 (UK Cardiac Surgical Register) to £60 (Scottish Hip Fracture Audit) Raftery J, Roderick P, Stevens A. Potential use of routine databases in health technology assessment. Health Technol Assess 2005;9(20) Whatever source of information •Timely feedback •Accessible to clinicians •Case mix adjustment Case mix adjustment Limited within administrative data? • Age • Sex • Emergency/Elective Risk adjustment models using HES on 3 index procedures •CABG •AAA •Bowel resection for colorectal cancer Risk factors Age Recent MI admission Sex Charlson comorbidity score (capped at 6) Method of admission Number of arteries replaced Revision of CABG Part of aorta repaired Year Part of colon/rectum removed Deprivation quintile Previous heart operation Previous emergency admissions Previous abdominal surgery Previous IHD admissions ROC ROC curve areas comparing ‘simple’, ‘intermediate’ and ‘complex’ models derived from HES with models derived from clinical databases for four index procedures 1 0.95 0.9 HES Simple model (Year, age, sex) HES Intermediate model (including method of admission) HES Full model Best model derived from clinical dataset 0.85 0.8 0.75 0.7 0.65 0.6 0.55 0.5 CABG AAA - unruptured AAA - ruptured Colorectal excision for cancer Index procedure Aylin P; Bottle A; Majeed A. Use of administrative data or clinical databases as predictors of risk of death in hospital: comparison of models. BMJ 2007;334: 1044 Calibration plots for ‘complex’ HES-based risk prediction models for four index procedures showing observed number of deaths against predicted based on validation set Surgery for colorectal cancer Operative mortality 10% Observed mortality Model 9% 8% 7% 6% 35% 30% 25% 20% 5% 4% 15% 3% 10% 2% 5% 1% 0% 0% 1 2 3 4 5 6 7 8 9 10 All 1 2 3 4 5 6 7 8 Deciles based on risk 9 10 All Deciles based on risk Surgery for ruptured AAA Surgery for unruptured AAA 80% Operative mortality Operative mortality Operative mortality Surgery for isolated CABG 70% 60% 50% 35% 30% 25% 20% 40% 15% 30% 10% 20% 5% 10% 0% 0% 1 2 3 4 5 6 7 8 9 10 All Deciles based on risk 1 2 3 4 5 6 7 8 9 10 All Deciles based on risk Aylin P; Bottle A; Majeed A. Use of administrative data or clinical databases as predictors of risk of death in hospital: comparison of models. BMJ 2007;334: 1044 Current casemix adjustment model for each procedure and diagnosis Adjusts for • age • sex • emergency status • socio-economic deprivation • diagnosis subgroup (3 digit ICD10) or procedure subgroup • co-morbidity – Charlson index • number of prior emergency admissions • palliative care • year • Month of admission (for some respiratory diseases) Current ROC (based on 1996/7-2006/7 HES data) for 30 day inhospital mortality •Repair of AAA = 0.792 •Infra-inguinal bypass = 0.800 •AP resection of rectum = 0.808 •Anterior resection of rectum = 0.813 •Hip replacement = 0.851 •Transplantation of heart and lung = 0.569 •Excision of head of pancreas = 0.681 •Graft of bone marrow = 0.666 Issues Important to only adjust for parameters outside the control of the unit in question Comparison of percentage of AVSD operations including outcome (death, alive or unknown) by age at admission (in months) between UBHT and elsewhere in England during supra-regional funding period (HES 1 April 1991 to 31 March 1995) aged under 18 months 40% 40% Elsewhere - Died Elsewhere - Alive or unknown UBHT - Died UBHT - Alive or unknown 35% Percentage 30% 35% 30% 25% 25% 20% 20% 15% 15% 10% 10% 5% 5% 0% 0% 0 1 2 3 4 5 6 7 8 9 Age in months 10 11 12 13 14 15 16 17 Comparison of percentage of open operations including outcome (death, alive or unknown) by age at admission (in months) between UBHT and individual centres during supra-regional funding period (HES 1 April 1991 to 31 March 1995) aged under 18 months 40% 35% Percentage of operations 30% 25% 20% 15% Other centres UBHT 10% 5% 0% 0 1 2 3 4 5 6 7 8 9 10 Age at operation in months 11 12 13 14 15 16 17 Presentation of clinical outcomes “Even if all surgeons are equally good, about half will have below average results, one will have the worst results, and the worst results will be a long way below average” • Poloniecki J. BMJ 1998;316:1734-1736 Th e ve rs ity ni R Lo nd o al F oy ol le ge C n H os pi ta lN St H M re S H a So e am ry Tr H 's ut us m a h N m t e H M rs p st S U a m n ea ni T i c t r h v he us d H H N st t os os H er N S pi pi o U ta ta tti T n r ls ls ng us iv N C ha H t H ov os m S en p Tr C ita try ity us lN an t H H os d S St pi W Tr ta G ar us lN eo w t ic H rg ks S e' Ki h T s ire ng ru He st 's N al C HS th O ol xf ca U l T e or ni re ge ru d ve st N H R rs H os ad ity S pi cli T H ta ru ffe os lN st pi H H os ta S ls pi T Br ta of R ru oy lN ig st Le ht al H ic on S Br es T om H t ru er ea st pt N lth on H C S C en an ar T ru tra d e Th st Pa H N lM Bl ar HS e pw ac ef an C kp ie Tr or ar ch ld oo th di us es ot N t H lV te H ho os ic ra S H r p t ac ul or T nd i t la r al ic ia us M nd N C H t an H en os Ea S ch t p r Tr st ita e es us -L Yo lN te t iv rC rk H er S sh hi p Tr ire oo ld us re lN H t n' os H s S pi U Ba t U Tr ni a ni l v rt' us s ve H s N t os an H rs S ity pi d T t Th al H r us s os e N t Lo pi H ta S nd lB T on r i us rm Pl N N ym t in or H gh S th ou T a St th r m u af Sh st H N fo os ef H rd S fie pi sh ta T ld ru ire ls Te st NH H ac os S hi G pi T ng uy ta ru lN 's st Ho an H sp U S d ni ita Tr St te ls us d Th N Br t H om is S to as Tr So lH 's us ut ea N t h Le H lth Te S ed c N Tr ar es s ew e us Te H NH ca t os ac st So S pi hi l e t Tr ng al ut U s us ha po H N t m os n H pt S Ty pi on t T ne al r us s U H N ni t os H ve S pi rs t T al ity r us s H N t os H S pi ta Tr ls us N t H S Tr us t U HSMR RR of death following CABG HES data 1999/00 to 2001/02 4.5 4 3.5 3 2.5 2 1.5 1 0.5 0 Centre Criticisms of ‘league tables’ • Spurious ranking – ‘someone’s got to be bottom’ • Encourages comparison when perhaps not justified • 95% intervals arbitrary and no consideration of multiple comparisons • Single-year cross-section – what about change? Account has to be taken of chance variation Bayesian approach using Monte Carlo simulations can provide confidence intervals around ranks Can also provide probability that a unit is in top 10%, 5% or even is at the top of the table See Marshall et al. (1998). League tables of in vitro fertilisation clinics: how confident can we be about the rankings? British Medical Journal, 316, 1701-4. ity ve rs oy ol le ge R C Lo nd o n os pi ta H Th al lN St Fr e H M S H ar So am ee Tr y H ' ut us s m am h N t e H M rs p st S U a m nc ea ni T i t ru h v he d H H st N st os os H er N S p pi o i U ta ta tti T n ru ls ls ng iv st N C ha H H ov os m S en p Tr C i t try al ity us N an t H H os d S St pi W Tr ta G ar us lN eo w t ic H rg ks S e' Ki h Tr s ire ng H us ea 's N t C H lth O ol S xf ca U l T e or ni r g r e us e d ve N H t R rs H os ad ity S p c T ita lif H r f u os e lN st pi H H os ta S ls pi T Br ta of R ru oy lN ig st Le ht al H ic on S Br es T om H te ru ea rN st pt lth on H C S C en an ar T ru tra d e Th st Pa H N lM Bl ar H e pw ac S ef an C kp ie Tr or ar ch ld oo th di us es ot N t H lV te H ho os ic ra S H r p to ac ul T nd i t la ria ru al ic st M nd N C H an H en os Ea S ch t p re Tr st ita es us -L Yo lN te t iv rC rk H er S sh hi p Tr ire oo ld us re lN H t n' os H s S pi U B ta U Tr ni ar ni ls v us t's ve H N t os an H rs S ity pi d Tr ta Th H ls us os e N t Lo pi H ta S nd lB Tr o n irm us Pl N N ym t in or H gh S th ou T a St th r m u af Sh st H N fo os ef H rd S fie pi sh ta T ld ru ire ls Te st N H ac H os S h G pi in T uy ta ru g lN 's st H os an H U S pi d ni ta Tr St te ls us d Th N Br t H om is S to as Tr So lH 's us ut ea N t h Le H lth Te S e c N ds Tr ar es ew e us Te H N ca t os ac H st So S pi hi l e ta T ng ut U ru ls ha po st H N m os n H pt S Ty pi on ta Tr ne ls us U H N ni t os H ve S pi rs ta Tr ity ls us H N t os H S pi ta Tr ls us N t H S Tr us t ni U Ranking Rankings for CABG mortality 1999/00 to 2001/02 35 30 25 20 15 10 5 0 Centre Statistical Process Control (SPC) charts Shipman: • Aylin et al, Lancet (2003) • Mohammed et al, Lancet (2001) • Spiegelhalter et al, J Qual Health Care (2003) Surgical mortality: • Poloniecki et al, BMJ (1998) • Lovegrove et al, CHI report into St George’s • Steiner et al, Biostatistics (2000) Public health: • Terje et al, Stats in Med (1993) • Vanbrackle & Williamson, Stats in Med (1999) • Rossi et al, Stats in Med (1999) • Williamson & Weatherby-Hudson, Stats in Med (1999) Common features of SPC charts Need to define: • in-control process (acceptable/benchmark performance) • out-of-control process (that is cause for concern) Test statistic • difference between observed and benchmark performance • calculated for each unit at each time point Pre-defined alarm threshold • minimise false alarms but remain sensitive to true signals Types of SPC chart Shewhart • test statistic based on current observation only • no formal adjustment for multiple testing Funnel plots • Can incorporate adjustment for between centre variation • Easy to interpret Mortality for paediatric cardiac surgery, 1991-Mar 95 for open operations for children aged under 1 year using SCTS data with 95% and 99.8% control limits based on the national average 40.0% 35.0% Mortality rate 30.0% 25.0% Bristol 20.0% 15.0% 10.0% 5.0% 0.0% 0 100 200 300 400 500 600 Number of operations 700 800 900 Funnel plots • No ranking • Visual relationship with volume • Takes account of increased variability of smaller centres Prospective surveillance and multiple testing • No prior hypothesis • Prospective surveillance involves monitoring at multiple time points • Sensitivity and specificity of surveillance methods depend on number of tests (time points) carried out • Statistical process control charts (SPC) among the most widely used methods for sequential analysis • Care required when applying SPC charts in health care setting Prospective SPC charts Cumulative sums of outcomes accumulate information on performance over time formal assessment of sensitivity and specificity different ways of deriving test statistic • Log-likelihood CUSUM (our preferred method) • Sequential Probability Ratio Test (SPRT) • Exponentially Weighted Moving Average (EWMA) Risk-adjusted Log-likelihood CUSUM charts STEP 1: estimate pre-op risk for each patient, given their age, sex etc. This may be national average or other benchmark STEP 2: Order patients chronologically by date of operation STEP 3: Choose chart threshold(s) of acceptable “sensitivity” and “specificity” (via simulation) STEP 4: Plot function of patient’s actual outcome v pre-op risk for every patient, and see if – and why – threshold(s) is crossed More details • Based on log-likelihood CUSUM to detect a predetermined increase in risk of interest • Taken from Steiner et al (2000); pre-op risks derived from logistic regression of national data • The CUSUM statistic is the log-likelihood test statistic for binomial data based on the predicted risk of outcome and the actual outcome • Models can adjusts for age, sex, emergency status, socio-economic deprivation etc. AAA mortality monitoring 5 4 3 2 CUSUM Value 1 statistic Lower SMR 0 limit 1 21 Patient number 41 61 81 My Practice Score Cards Urology Score Card Page 2 – Urology – Scrotal procedures How do you interpret performance data? Pyramid model of investigation to find credible cause explanation Lilford et al. Lancet 2004; 363: 1147-54 How do you interpret performance data? •Check the data •Difference in casemix •Examine organisational or procedural differences •Only then consider quality of care Challenges •Data quality •Consensus •Primary care •Does information change practice? Food for thought • an estimated one in ten patients admitted to hospital suffers an adverse event • an estimated 850,000 adverse events might occur each year in NHS hospitals • some adverse events will be inevitable complications of treatment, but around half may be avoidable - that is, over 400,000 potentially avoidable adverse events every year Vincent, C.A. Presentation at BMJ conference ‘Reducing Error in Medicine;London. March 2000 Adverse events in British hospitals: preliminary retrospective record review Charles Vincent, Graham Neale, and Maria Woloshynowych BMJ 2001; 322: 517-519. Food for thought • eight per cent of adverse events result in death and six per cent in permanent disability - that is, over 34,000 preventable deaths and over 25,000 preventable permanent disabilities every year • compensation for clinical negligence costs the NHS more than £400 million a year and altogether outstanding claims for clinical negligence add up to over £2.4 billion. Vincent, C.A. Presentation at BMJ conference ‘Reducing Error in Medicine;London. March 2000 Adverse events in British hospitals: preliminary retrospective record review Charles Vincent, Graham Neale, and Maria Woloshynowych BMJ 2001; 322: 517-519.