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Table 3 Summary of feasibility criteria

From: A mixed-method feasibility study of the use of the Complete Vocal Technique (CVT), a pedagogic method to improve the voice and vocal function in singers and actors, in the treatment of patients with muscle tension dysphonia: a study protocol

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?