Table 3 Evaluation of data collection procedures

Patient-facing (questionnaires)

All patient-facing data collection forms have been reviewed for their suitability by Patient and Public Involvement (PPI) group

PPI members advised on the wording and format of questionnaires. PPI will provide a lay perspective on interpretation of feasibility findings.

The feasibility of distribution and collection of patient questionnaires by receptionists.

Researcher’s field notes and follow-up correspondence with practices.

Process evaluation interviews with patients.

Consideration of distribution by another means e.g. in the post (or email) prior to consultation.

The appropriateness of collecting demographic data by patient self-report on pre-consultation questionnaires, as opposed to through the medical record.

Review of completeness of relevant items on patient questionnaires. Process evaluation interviews to discuss potential reasons for missing data. Correspondence with practices regarding practicalities of accessing patient demographic data with consent.

Consideration of accessing patient baseline data through practice records.

Whether patient participants require assistance, encouragement or supervision to complete either of the questionnaires.

Researcher’s field notes and process evaluation interviews.

The provision of assistance to patients when completing questionnaires, e.g. providing staff to assist them or allowing more time pre- or post-consultation to allow the patient to seek help from a third party.

Issues regarding time taken for questionnaire completion, any difficulties with comprehension of questionnaire items, numbers of questionnaires returned and reasons for missing data

Relevant quantitative data will be reported descriptively. Issues will be explored qualitatively with patients during process evaluation.

Time taken for completion may inform decisions surrounding when and how to distribute questionnaires. Issues regarding comprehension of specific items may lead to rewording with the assistance of the PPI group.

GP-facing (questionnaires and patient consent forms)

Issues regarding time taken for consenting patients, any difficulties with comprehension of items and reasons for missing data

Relevant quantitative data will be reported descriptively. Issues will be explored qualitatively with GPs during process evaluation.

Amendments to wording of consent form. Re-costing of incentive payments to practices if necessary, for extra consultation time to allow for consent.

Issues regarding operation of video-camera to record consultation

Rates of incomplete, unusable or missing recordings will be reported. Issues will be explored qualitatively with GPs during process evaluation, through the researcher’s field notes and through correspondence with practices regarding any setup difficulties.

Review of existing technology and equipment provided, consideration of the need for prompts for GPs to initiate videos

Issues regarding time taken for questionnaire completion, any difficulties with comprehension of questionnaire items, numbers of questionnaires returned and reasons for missing data

Relevant quantitative data will be reported descriptively. Issues will be explored qualitatively with GPs during process evaluation.

Issues regarding comprehension of specific items may lead to rewording. Re-costing of incentive payments to practices if necessary, for extra consultation time to allow for completion.

Researcher-facing (score sheets and templates)

The ability of members of the research team, to complete OPTION(5) score sheets based on review of video-recorded consultations.

Inter-rater reliability of OPTION(5) scores will be evaluated by calculating the inter-class correlation coefficient on ratings of all videos, aiming for values above 0.75. Comparisons will be made with other studies.

The completeness and usability of video-recordings will also be reviewed as described above.

Review of training procedures for OPTION(5) measure if correlation low. Review of appropriateness of the measure in the context of this study if training appears sufficient. Consideration of the need for development of an alternative measure to be piloted ahead of a definitive trial.

The case note template will be assessed for usability.

Any difficulties with comprehension of items by the research team will be reviewed in team meetings.

Any challenges when obtaining the information required on case note review forms, including accessing and interpreting the information from the patient’s medical record, will be reviewed at team meetings.

Inter-rater reliability for items on the case note review form will be evaluated by calculating an ICC on 20% of the data.

Re-wording and re-formatting of the template.

Review of the qualifications required by the research team e.g. clinical academics only and level of qualification if so.

Consideration of time frame for data collection, e.g. is 28 days sufficient to allow the notes to ‘settle’ and to capture all relevant documentation.