Table 2.
Screening and data collection across the trial: summary of the key trial processes from receipt of the invite reply from the potential participant to the data collection time points
| CRF | Completed by | Database | Preconsent | Baseline | 3 m | 6 m | 12 m | Ongoing or during treatment | Ref |
|---|---|---|---|---|---|---|---|---|---|
| Invite reply | P | RT | X | na | |||||
| Screening Questionnaire | P/TT | M | X | na | |||||
| Consent | P | R | X | na | |||||
| Sample requisition form | RN | RT | X | na | |||||
| Adverse events form | TT | M | X | na | |||||
| Drop-out event form | TT | M | X | na | |||||
| Note review form | TT | M | X | na | |||||
| IBS-SSS | P | R | X | X | X | X | 23 | ||
| WASAS | P | R | X | X | X | X | 24 | ||
| SGA | P | R | X | X | X | 25 | |||
| EQ5D | P | R | X | X | X | X | 26 | ||
| Patient enablement | P | R | X | X | X | 27 | |||
| Hospital Anxiety and Depression Scale | P | R | X | X | X | X | 28 | ||
| Client Service Receipt Inventory | P | R | X | X | X | X | 29 | ||
| Cognitive Scale CG-FBD | P | R | X | X | X | X | 30 | ||
| B-IPQ for IBS | P | R | X | X | X | X | 31 | ||
| IBS Behavioural Responses Questionnaire | P | R | X | X | X | X | 32 | ||
| BES | P | R | X | X | X | X | 33 | ||
| “Impoverished Emotional Experience (IEE)” factor of the Emotional Processing Scale-25 | P | R | X | X | X | X | 34 | ||
| PANAS | P | R | X | X | X | X | 35 | ||
| Demographics | P | R | X | na | |||||
| About your IBS | P | R | X | na | |||||
| Safety questions | P | R | X | X | X | na | |||
| Rating of satisfaction | P | R | X | X | X | 22 | |||
| Thoughts on my treatment | P | R | X | X | X | 36 | |||
| Therapist database | T | MT | X | na |
BES, Beliefs about Emotions Scale; B-IPQ, Brief Illness Perception Questionnaire; CG-FBD, Cognitive Scale for Functional Bowel Disoders; CRF, Case Report Form; IBS, Irritable bowel syndrome; IBS-SSS, IBS Symptom Severity Score; M, MACRO Clinical Trials Unit database; MT, MACRO Therapist database; na, not significant; P, patient; PANAS, Positive and Negative Affect Schedule; SGA, Subject's Global Assessment of Relief; R, LifeGuide Regul8; RN, Research Nurse/Phlebotomist; RT, Research Team database; T, therapist; TT, trial team; WASAS, Work & Social Adjustment Scale.