Table 5 Overview of outcomes regarding the feasibility of the pilot study and suggestions for improvement
Pilot study | Questions | RCT-study design relevant results | Improvement requirements and possible actions |
|---|---|---|---|
Recruitment procedures | Time till consent obtained from 20 GPs How many patients CG/2 weeks How many patients IG/2 weeks | 3 Months (expected two weeks); 6/20 GPs failed in recruitment 42 pat. in 12 months; 2pat. inaccurate 45 pat. in 4 months; 9 inaccurate | adapted to recruitment time findings Increase (at least double) the number of recruited GPs re-evaluate inclusion and exclusion criteria for patients, recruitment time and sample size of participating patients, recalculate sample size Check on included patients (fax or phone) if criteria are fulfilled; enhance recruitment in “slow” and stop “fast” recruiters when mean of correctly included pat. is reached. |
Supporting/contact strategies | personal calls info. Poster non advertised 100€ incentive at the end of the CG | Monthly Seasonally adapted Advertise & split incentives for CG & IG | increase the frequency of the contact-calls to study nurses (at least weekly) more target-group adapted flyers; a higher number of seasonally adapted posters; use of “new communication channels” such as electronic messaging on screens in practice waiting rooms financial reward for the additional workload of GP, staff and possibly for the patients. Direct incentive to medical staff, “pay per capita.” |
patients’ feedback tools | frequencies & lengths of data collection returned & completeness of paper-pen pain diary returned & completeness of questionnaires: OMPSQ*, FFbH-R* | adequate, but could also assess chronification 87% 90% complete data 97–83% 72% complete data | Follow up with assessments of pain intensity and painkiller intake for at least 12 weeks |
Data collection | faster pain reduction compared to standard care | Yes | |
phone interviews | 98% complete data | Recalculate costs (if two part-time study nurses collecting data (employed at 8%) are less expensive than prepared and prepaid envelopes, and recall-calls) | |
Information about excluded pat. | Not collected! | Rework layout of documentation sheet. Explain importance in more depth and advertise allowance for this completed sheet separately | |
feasibility of teaching specific MT techniques in 2 ½ hours | feasible | Assess MT quality by practice visit 2 weeks after MT-“training,” during IG |