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Research and outcomes

The Research and outcomes department are essential in daily clinical practice; conducting research to enable ideas and concepts for the improvement of patient care.

  • Building a successful research program involves multiple steps, with different challenges such as obtaining funding and establishing necessary training for staff;
  • time management as well as research personnel flexibility is vital to ensure success in undertaking any research studies; and
  • dedicated quality research time and maintaining consistent interaction with members of the team is also important.

The SWLEOC Research department was established circa 2006. The first research programs conducted were clinical studies involving the oral form of anticoagulant drugs and SWLEOC was one of the highest recruitment centres in the world.

Later the department conducted other studies such as multi centre, multi surgeon surveillance studies as well as National Institute for health and Care Research (NIHR) funded studies.

Patient interaction is involved for assessing eligibility criteria and recruitment process. The team also works in collaboration with the study sponsors and different orthopaedic staff within the UK and overseas centres.

The team is working in collaboration with the Elective Orthopaedic Centre in a designated research department office.

  • Research specific Outcomes database;
  • SWLEOC’s in-house patient management system;
  • Bluespier;
  • iCM;
  • iPM;
  • Microsoft Office;
  • PACs;
  • Traumacad; and
  • EDGE.
  • The steps to research study start-up;
  • identifying & involving potential sites and sponsors;
  • ethics application/submission; and
  • writing study protocol.
  • Low patient recruitment with aim to reach the study cohort;
  • different diagnostics that are done offsite;
  • Surgeon operation availability;
  • laboratory/equipment accessibility;
  • no permanent research office/working location;
  • staff availability;
  • data collection (i.e., collection or contacting patient >2years after); and
  • off-site archiving system.
  • ID and recruitment eligible and compliant patients;
  • flexibility with patients’ appointment;
  • good communications between patient and research staff/surgeon;
  • knowledge of surgeon’s flexibility and availability; and
  • timely data collection and data resolution.
  • No proper research training or experience for staff involved; and
  • Poor communication within the department as well as interdepartmental.
  • No general knowledge about the different studies;
  • communication;
  • staff availability; and
  • staff flexibility.
  • Good time management;
  • work flexibility of staff and sufficient research staff members;
  • good communication;
  • proper training for staff; and
  • resources/funding.
  • Taking on different research studies such as NIHR and clinical trials;
  • consistently aiming to have research publications;
  • conducting Annual Research Course; and
  • research conferences.
  • Staff rapid turnover; and
  • no-permanent working place.
  • Different SOPs created to ensure consistency especially for data collection and data recording;
  • research clinic booking;
  • clinic outcomes;
  • radiology request;
  • outcomes database report running;
  • research data entry;
  • data queries and resolution;
  • sample collection; and
  • sending sample to offsite laboratories.
  • Study invite letter;
  • mail merging;
  • outcomes database post op PROMs cover letters; and
  • outcomes database Research clinic appointment letters.

 

Outcome data collection templates are available here on FutureNHS:
Outcome Data Collection and Templates – Getting It Right First Time – FutureNHS Collaboration Platform

Staff

Staff members:

  • Research and Outcomes Director;
  • Research Deputy Director;
  • Research and Outcomes Manager;
  • Research Study and Outcomes Coordinator (1 WTE);
  • Research Nurse (0.8 WTE);
  • Research assistants (1.5 WTE);
  • Outcomes assistant (0.8 WTE); and
  • Research Office coordinator (1 WTE).

Roles:

  • coordinating different studies such as ODEP surveillance studies and different NIHR studies;
  • running report/s from BS for potential patients for both ODEP and NIHR studies;
  • patient recruitment;
  • study CRF completion;
  • ID missing data;
  • data resolution;
  • data entry;
  • organising study audit visits;
  • liaising with study sponsors, CRA for UK based centres and overseas centres;
  • organising and maintaining Study site files;
  • creating post-operative PROMs reports to identify patients due for their 6 weeks, 6 months, 1 year and 2 year;
  • sending post op PROMs via email (electronic) or by post;
  • daily syncing completed electronic forms from patients who opted for email questionnaires in the database;
  • creating post op ODEP reports to identify patients due for their annual postal questionnaires up to 10-year timepoint;
  • conducting ODEP clinic, Data entry, ID complication/AE/SAE;
  • outcoming clinic in BS;
  • patient recruitment for NIHR studies;
  • conducting post-surgery patient review clinic;
  • data entry and completion of any missing data mostly via telephone;
  • data clinic for ODEP studies;
  • printing and sending PROMs;
  • CRF filing;
  • amending GP details in the database and BS;
  • data entry;
  • CRF filing;
  • creating upcoming theatre list;
  • ID patients for sending pre op PROMs;
  • sending out pre op PROMs;
  • data entry and completion of any missing data via telephone;
  • sending completed PROMs booklet to quality health;
  • printing downloaded post op PROMs;
  • contacting patients and organising ODEP clinic appointments and updating database, clinic log;
  • circulating clinic list and x ray list for request;
  • preparing study folders/CRFs;
  • outcoming clinic on iPM; and
  • CRF archiving and patients’ notes archiving for future documentations and audit.