OBJECTIVE | MEASURE | QUESTIONS |
---|---|---|
PROCESS: FEASIBILITY OF THE PROCESSES THAT ARE KEY TO SUCCESS OF MAIN STUDY | ||
 Patients meeting eligibility criteria | • \(\frac{\textrm{Number}\ \textrm{of}\ \textrm{patients}\ \textrm{meeting}\ \textrm{eligibility}\ \textrm{criteria}}{\textrm{Total}\ \textrm{number}\ \textrm{of}\ \textrm{patients}\kern0.5em \textrm{presenting}\ \textrm{with}\ \textrm{primary}\ \textrm{MTD}}\times 100\%\) | • What is potential pool of patients with MTD? |
 Concurrent acceptability: Patients meeting eligibility criteria recruited | • \(\frac{\textrm{Number}\ \textrm{of}\ \textrm{patients}\ \textrm{recruited}}{\textrm{Total}\ \textrm{number}\ \textrm{of}\ \textrm{patients}\ \textrm{meeting}\kern0.5em \textrm{eligibility}\ \textrm{criteria}}\times 100\%\) • Qualitative data on reasons for non-recruitment | • What is potential recruitment rate? |
 Concurrent acceptability: Recruitment rates against target | • \(\frac{\textrm{Number}\ \textrm{of}\ \textrm{patients}\ \textrm{having}\ \textrm{at}\ \textrm{least}\ \textrm{one}\ \textrm{therapy}\ \textrm{session}}{\textrm{Total}\ \textrm{number}\ \textrm{of}\ \textrm{patients}\ \textrm{recruited}}\times 100\%\) • \(\frac{\textrm{Number}\ \textrm{of}\ \textrm{patients}\ \textrm{having}\ \textrm{at}\ \textrm{least}\ \textrm{one}\ \textrm{therapy}\ \textrm{session}}{\textrm{Total}\ \textrm{number}\ \textrm{of}\ \textrm{patients}\ \textrm{recruited}\&\textrm{consented}}\times 100\%\) • Number of patients recruited in 6 month time period • Qualitative data on reasons for non-recruitment following consent • Qualitative data on reasons for non-progression to therapy following consent & recruitment | • What is potential recruitment to therapy rate? • Can recruitment be improved by modifying eligibility and exclusion criteria? |
 Concurrent acceptability: Total number of patients completing the study | • \(\frac{\textrm{Number}\ \textrm{of}\ \textrm{patients}\ \textrm{completing}\ \textrm{the}\ \textrm{study}}{\textrm{Total}\ \textrm{number}\ \textrm{of}\ \textrm{patients}\ \textrm{recruited}}\times 100\%\) • Number of patients completing the study | • How many patients completed the study? |
RESOURCES: ASSESSING TIME AND RESOURCE PROBLEMS THAT CAN OCCUR DURING MAIN STUDY | ||
 Determining process time | • Qualitative data: administration of clinic appointments including patients contact • Qualitative data: Length of time to complete research clinic tasks | • How many patients can be seen per hour? |
 Concurrent acceptability: Adherence to protocol | • Dropout rates % • Qualitative data: on reasons for non-completion of treatment • \(\frac{\textrm{Number}\ \textrm{of}\ \textrm{patients}\ \textrm{requesting}\ \textrm{further}\ \textrm{SLT}\ \textrm{therapy}\ \textrm{session}}{\textrm{Total}\ \textrm{number}\ \textrm{of}\ \textrm{patients}\ \textrm{recruited}\&\textrm{consented}}\times 100\%\) • Qualitative data: on reasons for requesting further therapy | • Does CVT-P address recruited MTD patients needs? |
 Patient costs | • Travel costs (median + range) | • What was the financial cost to the patient travelling to the research clinic appointments? |
 Missing data | • The amount of clinical outcomes data completed measured using the case report form at each time point (pre- and post-treatment) • Qualitative data: on reasons for missing data | • How much missing data is recorded and what where the reasons for this? |
MANAGEMENT: HUMAN & DATA MANAGEMENT PROBLEMS | ||
 Personnel/equipment/facility availability | • Qualitative data: Personnel/equipment/facility availability for research visits • Qualitative data: Equipment availability for patient • Qualitative data: issues with booking/attendance of therapy sessions | • Are there any issues with personnel/equipment/facility availability for research visits? |
 Retrospective acceptability: Teleheath | • Questionnaire using Likert scale (see Additional file 5: Patient/CVT-P goals and feedback questionnaire) | • Is the use of telehealth satisfactory for patients and the CVT-P? |
SCIENTIFIC: ASSESSMENT OF TREATMENT SAFETY, DOSE, RESPONSE, EFFECT, AND VARIANCE OF EFFECT | ||
 Study conduct | • Qualitative data: issues with documentation and data entry | • Is the Case Report Form adequate? • Is the Database adequate? |
 Safety | • Qualitative data of SLT-V observations of CVT-P sessions • Qualitative data: Feedback from any post-study SLT-VT • Reporting of adverse and serious adverse events • Qualitative data from sponsor monitoring visits | • Is CVT-VT safe to use healthcare intervention? |
 Concurrent acceptability: Number of CVT-VT sessions | • Average number of recorded CVT-VT sessions per patient • Qualitative data recording reasons for terminating sessions | • How many CVT-VT sessions were required on average? • Was this adequate? |
 Retrospective acceptability: Patient satisfaction with therapy | • Questionnaire using Likert scale: Descriptive statistics (see Additional file 5: Patient/CVT-P goals and feedback questionnaire) | • Was the patient satisfied with therapy received? |
 Retrospective acceptability: Achievement of patients goals | • Questionnaire using Likert scale: Descriptive statistics (see Additional file 5: Patient/CVT-P goals and feedback questionnaire) | • Did the patient achieve their pre-therapy goals following treatment? |
 Retrospective acceptability: CVT-P satisfaction with therapy | • Questionnaire using Likert scale: Descriptive statistics (see Additional file 5: Patient/CVT-P goals and feedback questionnaire) | • Was the CVT-P satisfied with therapy received? |
 Retrospective acceptability: Achievement of CVT-P goals | • Questionnaire using Likert scale: Descriptive statistics (see Additional file 5: Patient/CVT-P goals and feedback questionnaire) | • Did the CVT-P feel the pre-therapy goals agreed with the patient following treatment were met? |
 Primary outcome measure: Voice and vocal function | • Self-rated questionnaire (VHI): Inferential statistics: Difference in pre-post total scores , effect size | • Was the primary outcome measure for therapy achieved? |
 Secondary outcome measures: Throat symptoms | • Self-rated questionnaire (VTDS):Inferential statistics - Difference in pre-/post total scores , effect size | • Do these secondary outcome measures improve following therapy? |
 Secondary outcome measures: Aerodynamic measure | • MPT: Inferential statistics: Inferential statistics - Difference in pre-/post total scores , effect size | • Do these secondary outcome measures improve following therapy? |
 Secondary outcome measures: Objective voice measure & laryngeal vibratory pattern | • Acoustic/EGG measures: Inferential statistics - Difference in pre-/post total scores , effect size | • Do these secondary outcome measures improve following therapy? |
 Secondary outcome measures: Perceptual voice analysis | • Auditory-perceptual ratings (CAPE-V): Inter and intra-rater rating pre/post rating scores | • Do these secondary outcome measures improve following therapy? |