Making the best use of clinical datasets

M R C O G PA R T 2 · S O S P O C K E T C A R D · K N O W L E D G E A R E A 2 – T E A C H I N G A N D R E S E A R C H

Making the Best Use of Clinical Datasets Bach F, Toozs-Hobson P, Purnell J. Making the best use of clinical datasets: with examples from urogynaecology. TOG 2022;24:281–289. doi:10.1111/tog.12828

7 6 8 years CALDICOTT PRINCIPLES GDPR DATA PROTECTION PRINCIPLES HOSPITAL DATA RETENTION POST-TREATMENT

DO N' T-M IS S FA C TS

  1. Caldicott = 7 principles (confidentiality); GDPR = 6 data protection principles (handling + right to erasure). Both embedded in law.

  2. Hospital data retention: 8 years after completion of treatment. Register with the ICO if you hold personal data.

  3. Registries vs databases (Cumberlege): databases require consent; consent for implant data can be included in operative consent.

  4. Define the question first, work backwards; core (Delphi-derived minimum) + time-limited extended datasets.

  5. Normalisation rules: no repeating groups; separate table per related dataset; primary key for each; no multiple fields storing similar data.

  6. Missing data hierarchy: listwise deletion → pairwise deletion → single (hot/cold deck, mean) imputation → Rubin’s multiple imputation (handles not-missing-at-random).

  7. BSUG data-selection options: all centres; accredited centres only (or post-accreditation only); high volume >10 or >50 incontinence procedures/year; completeness threshold; primary vs repeat surgery.

  8. Mesh complication reporting is mandatory (Keogh 2013, NICE, MHRA) – a database is only a ‘double check’; duty of candour rests with the clinician/centre.

PERFECT DATABASE – 7 ATTRIBUTES

100% complete Accurate & validated Avoids bias No extra effort Clear aim Stakeholder-endorsed

Live relevant reporting

ABBREVIATION KEY

BSUG — British Society of Urogynaecology ICO — Information Commissioner’s Office

ICHOM — International Consortium on Health Outcome Measures PROM/PREM — patient-reported outcome/experience measure

IUGA — International Urogynecological Association MBRRACE-UK — Mothers and Babies: Reducing Risk through Audits and Confidential Enquiries GDPR — General Data Protection Regulation

Source: The Obstetrician & Gynaecologist (TOG), RCOG journal — 2022;24:281–289. doi:10.1111/tog.12828

Clinically reviewed by NHS obstetricians and gynaecologists

MRCOG AI is an independent educational tool. It is not affiliated with, endorsed by, or connected to the Royal College of Obstetricians and Gynaecologists (RCOG).

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