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PreFIT Decision Log

Date of Decision Topic Decision Decision Made by
12/05/2011 Screening Self Screen form not to be sent to patients in advice only arm TMG
12/05/2011 Advice Leaflet Leaflet to be randomised to go to only half of the patients in MFFP and Exercise arm TMG
12/05/2011 MFFP Training Snellen Chart to be used - and training to be providedin its use TMG
02/06/2011 Database  It was suggested that we have a block size of 3 (rather than 4) as the practices will be randomised simultaneously and therefore no prediction could be made about the next allocation. RL to confirm that this will be possible.
• If we recruit more than 12 practices in an area then either the last block size could be 1, 2 or 4. RL to confirm
02/06/2011 GP Invitations The minimum criteria for a practice is to be included in the trial was agreed to be as follows:
• Must have more than 2FTE GP’s employed
• Must have a list size of >600 patients aged >70
• Must have computerised records
15/06/2011 Core Outcomes  EQ5D (section 2) definitely to be collected for Follow-up questionnaires TMG
15/06/2011 “Dirty” data from PCT for safety reporting It was decided not to use SUS (Secondary User Service) data from the PCT. With regard to safety reporting we have the Self Report which will be quicker  TMG
15/06/2011 Exeter Visits  If overloading of services does become a problem it may be possible to use excess treatment money to fund extra physio support. TMG
15/06/2011 Mortality and loss to follow up rates  Estimated overall loss 18% (lost to follow up 10% + approx 8% mortality). TMG
15/06/2011 Clock Drawing Test  Simple scoring system to be used eg 6 point scale of Shua-Haim et al. 1996 TMG
30/06/2011 Recruitment of GP's Minimum practice size (600>70years) is a guide not a requirement. The minimum of 2 FTE GPs at a practice is also a guide, but larger practices are preferred.  TMG
30/06/2011 Recruitment of Participants Data collected per participant needs to include reason for exclusion, also age and sex  TMG
30/06/2011 Randomisation of Practice Do not randomise practices at the same time - allow staggering so that services are not overloaded TMG
30/06/2011 Screening Process Screening replies must be filed /retained at practice. Practices must inform us of - date sent / date reply rec’d / score for risk /referral date – Add to manuals. Must be clear for practices for all delivery of intervention forms TMG
30/06/2011 Progress of Participants through Interventions Do not need to collect the exercise treatment log; only the summary. This can be faxed to CTU by clinician TMG
30/06/2011 Follow up of Participants (Questionnaires and Falls Diaries) Follow up is to be timed from date of randomisation.  TMG
30/06/2011 Follow up of Participants (Questionnaires and Falls Diaries) Missing data – if missing items, do not chase; missing page, do chase. Monitor workload for this TMG
30/06/2011 Follow up of Participants (Questionnaires and Falls Diaries) Data checking procedure to be agreed ‘light touch’ recommended – 10% for Pilot to test formic and then decide going forward. Need to know error rates for pilot TMG
30/06/2011 Follow up of Participants (Questionnaires and Falls Diaries) Missing data – validate and leave as blank (Formic) TMG
30/06/2011 Collection of Data GP reports to be annual not ¼ly. Safety monitoring will be on self report only TMG
30/06/2011 Collection of Data Research nurse to collect this for the practice TMG
30/06/2011 Collection of Data Do need to consider safety tracking for the main trial where we are not nec’ collecting data from all participants TMG
30/06/2011 Futility Analysis/Data Analysis Must be careful that futility analysis helps rather than hinders (trial shut down) - no report to go out of the Unit without ok from SL TMG
30/06/2011 Identification of Regions Change to training for GPs does mean that we can approach Coventry TMG
01/07/2011 Identification of Regions Must have identified all regions by HTA review meeting TMG
04/08/2011 Data Management Queries Q2.7a – Some participants have crossed out the word bath and replaced it with “shower”. A decision was made that where an answer has been selected that it would be blocked out because the participant has not answered the original question. The field will then be classed as missing data. This will also apply to any other fields where the question has been changed TMG
04/08/2011 Data Management Queries Q5.1 to 5.11 – This section requires YES/NO answers. Some participants have answered YES to a few questions and left the other questions unanswered. After discussion it was felt that it shouldn’t be assumed that these were “NO” answers and should be classed as missing data. A decision could then be made at a later date by the Statistician on how this data should be treated TMG
04/08/2011 Data Management Queries Q7 Clock Scoring – It was decided that where a participant had not attempted the clock test it should not be scored as zero but as missing data. TMG
04/08/2011 Pilot Study - Practices to Target The response rate so far shows a nose dive after week 2 and so it was decided that reminder packs would be sent out at the end of week 2. TMG
04/08/2011 Pilot Study - Practices to Target Response rate will be monitored and a revision of the number of initial letters sent will be made based upon the data from the pilot TMG
04/08/2011 AOB It was bought to the attention of the TMG that a disturbing letter had been received from a participant along with her baseline questionnaire. It was decided that it should be bought to the attention of MU as soon as possible to question whether we have a duty of care to inform the GP and decide what policy should be established for any future issues of a similar nature. EJW/MU to review on a case by case basis. Record to be kept of additional letters received. TMG
06/10/2011 Main Study  Next sites to be set up will be Warwickshire (incl Leamington and Rugby), Coventry and Herefordshire TMG
06/10/2011 Main Study  Herefordshire: CB said there were approx 24 practices across the region and we would need to recruit half of these. This led to discussion on the possibility of setting up more or less practices within a region i.e. recruiting 2 clusters (6 practices) in Herefordshire and a further cluster in Devon where we are already set up or another region where there are more practices. It was decided that this was feasible as long as 60 practices in total were recruited. TMG
06/10/2011 HTA Report RLa to plan the data section of the report after Christmas and circulate. There should be sufficient progress and 4mth follow up data from the pilot by beginning of Feb for RLa to analyse. Report to be ready by mid-Feb. TMG
06/10/2011 Timeline We will still be collecting HES data after the trial is complete. We can go with setting up more or less practices per region than the 12 x 5 originally planned but will still need to recruit 60 practices regardless of number of regions. Rate limiting steps appear to be the meetings/time involved in set up and the labour intensive manual tasks such as pack preparation. It may be better to buy in some extra time to help with this and keep to the timeline rather than having to extend the trial. It was decided to stick with the current draft timeline and reassess at the beginning of January. TMG
06/10/2011 Intervention Documentation MU and SH felt that the GP referral to Exercise and MFFP forms were superfluous and that it might be better to use existing referral forms from within individual practices and just add a sticker containing the PreFIT logo and TNO TMG
06/10/2011 Intervention Documentation MU suggested that the Exercise Treatment form and the Exercise Summary Treatment log should be merged into one A3 form. Likewise with the MFFP Risk Assessment form and its associated Summary Treatment Log. It was decided to add in a numerical rating score (NRS) for each visit to record strength and balance. TMG
06/10/2011 Falls Diaries Timing for Falls Diaries starts from Practice Randomisation (Baseline).  TMG
06/10/2011 AOB Physios to be asked to block out some appointments in readiness for PreFIT patients. TMG
06/10/2011 AOB NWs working time for PreFIT was increased to 60% from 01 Oct TMG
06/10/2011 AOB T/con to be arranged between Iain Lang/JB/SH/EJW and possibly Ray Sheridan/CB to discuss way forward and how secondary services will be able to access the ETCs.  TMG
06/10/2011 AOB Also need to get the “buy in” of Graham Bamforth’s boss that this is an extremely worthwhile trial and will be done in the area. TMG