formal experiments: randomisation + study size. concept of randomisation biology, 1926: sir ronald...

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Formal experiments: randomisation + study size

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Randomisation in medicine Toss of coin determines experimental or control treatment RCT assignment unpredictable Fair [=> ethical] allocation of scarce resource Balance treatment numbers overall, in each hospital, and for major prognostic factors

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Page 1: Formal experiments: randomisation + study size. Concept of randomisation Biology, 1926: Sir Ronald Fisher Medicine, 1947: Sir Austin Bradford Hill Randomised

Formal experiments: randomisation + study size

Page 2: Formal experiments: randomisation + study size. Concept of randomisation Biology, 1926: Sir Ronald Fisher Medicine, 1947: Sir Austin Bradford Hill Randomised

Concept of randomisation• Biology, 1926: Sir Ronald Fisher

• Medicine, 1947: Sir Austin Bradford Hill Randomised Controlled Trial

• Criminal justice ?

Page 3: Formal experiments: randomisation + study size. Concept of randomisation Biology, 1926: Sir Ronald Fisher Medicine, 1947: Sir Austin Bradford Hill Randomised

Randomisation in medicine

• Toss of coin determines experimental or control treatment RCT assignment unpredictable

• Fair [=> ethical] allocation of scarce resource

• Balance treatment numbers overall, in each hospital, and for major prognostic factors

Page 4: Formal experiments: randomisation + study size. Concept of randomisation Biology, 1926: Sir Ronald Fisher Medicine, 1947: Sir Austin Bradford Hill Randomised

RCT Telephone Randomisation

Page 5: Formal experiments: randomisation + study size. Concept of randomisation Biology, 1926: Sir Ronald Fisher Medicine, 1947: Sir Austin Bradford Hill Randomised

Licensing of pharmaceuticals: requires efficacy in RCTs

• Patients’ informed consent [ethics]

• Sufficiently-large [precise answer]

• Randomised [unbiassed: like with like]

Page 6: Formal experiments: randomisation + study size. Concept of randomisation Biology, 1926: Sir Ronald Fisher Medicine, 1947: Sir Austin Bradford Hill Randomised

“What works” in UK criminal justice?

Large RCTsessentially untried . . .

(bar restorative justice)

Page 7: Formal experiments: randomisation + study size. Concept of randomisation Biology, 1926: Sir Ronald Fisher Medicine, 1947: Sir Austin Bradford Hill Randomised

Judges prescribe sentence on lesser evidence than doctors

prescribe medicines

Is publicaware?

Page 8: Formal experiments: randomisation + study size. Concept of randomisation Biology, 1926: Sir Ronald Fisher Medicine, 1947: Sir Austin Bradford Hill Randomised

Drug Treatment &Testing Orders (DTTOs)

• England & Wales: 210 clients

• Scotland: 96 clients

• Targets for DTTO clients in E&W: 6,000+ per annum

• DTTO clients: 21,000+ by end 2003

Page 9: Formal experiments: randomisation + study size. Concept of randomisation Biology, 1926: Sir Ronald Fisher Medicine, 1947: Sir Austin Bradford Hill Randomised

RSS Court DTTO-eligible offenders: do DTTOs work ?

• Off 1 DTTO• Off 2 DTTO• Off 3 alternative =• Off 4 DTTO• Off 5 alternative =• Off 6 alternative =

Count offenders’ deaths, re-incarcerations etc . . .

Page 10: Formal experiments: randomisation + study size. Concept of randomisation Biology, 1926: Sir Ronald Fisher Medicine, 1947: Sir Austin Bradford Hill Randomised

UK courts’ DTTO-eligible offenders: ? guess

• Off 7 DTTO [ ? ]• Off 8 DTTO [ ? ]• Off 9 DTTO [ ? ]• Off10 DTTO [ ? ]• Off11 DTTO [ ? ]• Off12 DTTO [ ? ]• Off13 DTTO [ ? ]• Off14 DTTO [ ? ]

(before/after) Interviews versus . . . [ ? ]

Page 11: Formal experiments: randomisation + study size. Concept of randomisation Biology, 1926: Sir Ronald Fisher Medicine, 1947: Sir Austin Bradford Hill Randomised

Evaluations-charade• Failure to randomise

• Failure to find out about major harms

• Failure even to elicit alternative sentence funded guesswork on relative cost-effectiveness

• Volunteer-bias in follow-up interviews

• Inadequate study size re major outcomes . . .

Page 12: Formal experiments: randomisation + study size. Concept of randomisation Biology, 1926: Sir Ronald Fisher Medicine, 1947: Sir Austin Bradford Hill Randomised

Power (study size) matters!

Back-of-envelope sum for 80% power

e. g. Percentages

If MPs/social scientists don’t know,

UK plc keeps hurting

Page 13: Formal experiments: randomisation + study size. Concept of randomisation Biology, 1926: Sir Ronald Fisher Medicine, 1947: Sir Austin Bradford Hill Randomised

For 80% POWER, 5% significance: compare failure (re-conviction) ratesRandomise per treatment group,

8 times STEP 1 answer

STEP 1: Success * fail rate + Success * fail rate for new disposal for control ------------------------------------------------------------(new success rate – control success rate)2

Page 14: Formal experiments: randomisation + study size. Concept of randomisation Biology, 1926: Sir Ronald Fisher Medicine, 1947: Sir Austin Bradford Hill Randomised

DTTOs: target 60% versus control 70% re-conviction rate?Randomise per ‘CJ disposal’ group, 8 times STEP 1 answer = 8 times 45 = 360

STEP 1 answer:

40 * 60 + 30 * 70 2400 + 2100 DTTOs control --------------------------------- = --------------- (40 – 30)2 100

Page 15: Formal experiments: randomisation + study size. Concept of randomisation Biology, 1926: Sir Ronald Fisher Medicine, 1947: Sir Austin Bradford Hill Randomised

Four PQs for every CJ initiative• PQ1: Minister, why no randomised controls?

• PQ2: Minister, why have judges not even been asked to document offender’s alternative sentence that this CJ initiative supplants?

{cf electronic tagging}

• PQ3: What statistical power does Ministerial pilot have re well-reasoned targets?

{or, just kite flying . . .}

• PQ4: Minister, cost-effectiveness is driven by longer-term health & CJ harms, how are these ascertained? { database linkage}

Page 16: Formal experiments: randomisation + study size. Concept of randomisation Biology, 1926: Sir Ronald Fisher Medicine, 1947: Sir Austin Bradford Hill Randomised

Randomised controlled trials

to

police Policy

by

Home OfficePrisons

&

Criminal Justice

Page 17: Formal experiments: randomisation + study size. Concept of randomisation Biology, 1926: Sir Ronald Fisher Medicine, 1947: Sir Austin Bradford Hill Randomised

HMP Peterborough PILOT: Kalyx prison, Social Finance run, & payment by results.What happens?

HMP Peterborough Eligible Pre-release Inmate (serving less than 12 months)

Taken on by SF

Yes No

Transfer’dOut . . .

No Yes No Yes

Deselected

by SF

No Yes N/A orYes

AlreadyDone!

N/A

HMP Peterborough release

YES Yes, but . . .

NO Yes, but . . .

NO

Matchedcontrols?

? ?

Page 18: Formal experiments: randomisation + study size. Concept of randomisation Biology, 1926: Sir Ronald Fisher Medicine, 1947: Sir Austin Bradford Hill Randomised

HMP Peterborough PILOT: Kalyx prison, Social Finance run, & payment by results.

Per SF-release, comparators are? 10 same-sex ‘matched’ prisoners who also served

less than 12 months & were released on same day but from other prisons

{All Kalyx-run? Where? Functionality? Locality?De-selections & transfers?}

Reduce convictions in 1st year post-release by 7.5% . . . Conviction costed how . . . ???

{eg 60% to 55.5% convicted within 1 year of release ~ or reduce conviction-count by 7.5%}

Page 20: Formal experiments: randomisation + study size. Concept of randomisation Biology, 1926: Sir Ronald Fisher Medicine, 1947: Sir Austin Bradford Hill Randomised

Guardian Society: 17 Nov. 2004

“Some statisticians are so severe that they would stop social policy

making in its tracks.

For example, Bird would forbid the government to introduce any policy that had not been assessed through

controlled trials. . . ”

Page 21: Formal experiments: randomisation + study size. Concept of randomisation Biology, 1926: Sir Ronald Fisher Medicine, 1947: Sir Austin Bradford Hill Randomised

SIMPLE RANDOMISATIONSTEP 1: Correspondence between random

number (see tables) & CJ disposal: EVEN random number (0) DTTO ODD random number alternative

STEP 2: Document starting point in tables & direction of reading: SMB = down

03 (row) 07 (column)

Page 22: Formal experiments: randomisation + study size. Concept of randomisation Biology, 1926: Sir Ronald Fisher Medicine, 1947: Sir Austin Bradford Hill Randomised

RANDOM NUMBER tables72137 73850 3273348083 50731 5058416602 26772 81250 row 3, column 7:55480 29910 89693 read down77708 83761 47184

12601 5443265664 73669

Page 23: Formal experiments: randomisation + study size. Concept of randomisation Biology, 1926: Sir Ronald Fisher Medicine, 1947: Sir Austin Bradford Hill Randomised

SIMPLE RANDOMISATION: down

Offender Random # Disposal Outcome Court & JCJ01 6 DTTO CB2CJ02 9 alternative CB2CJ03 3 alternative CB2CJ04 4 DTTO CB2CJ05 3 alternative CB2CJ06 etc CB2CJ07 CB2CJ08 CB2Correspondence: random # & disposal

EVEN = DTTO

ODD = alternative

Row 03Col 07

Page 24: Formal experiments: randomisation + study size. Concept of randomisation Biology, 1926: Sir Ronald Fisher Medicine, 1947: Sir Austin Bradford Hill Randomised

Randomisation by minimisation: next client = Cambridge, male,

18-24 years, >5 prison termsClient RCT assignmentscharacteristic so far to DTTO alternative

Cambridge 20 15 *male 205 190 *18-24 years 100 * 108>5 in-prison 180 * 185

SUM points: 505 498 **

RANDOMISE this client preferentially (eg 80:20) to ** because lower on points

Page 25: Formal experiments: randomisation + study size. Concept of randomisation Biology, 1926: Sir Ronald Fisher Medicine, 1947: Sir Austin Bradford Hill Randomised

Critical reading: BMJ, Lancet etcStatistical guide-lines for contributors to medical

journals (20+ years): beware “bars”

Structured ABSTRACT: essential design & primary outcome (s)

CONSORT flowchart for reporting RCTs: beware i) post-randomization exclusions from analysis;

ii) post-hoc subgroups.

STROBE guide-lines for reporting observational studies: beware bias in many guises

(especially: how explanatory variable is coded at analysis - eg binary!! & retrospective classification: deaths on transplant waiting list ~ count

survival contribution on the waiting list of transplantees beofre operation)