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Table 4 Outcome measures

From: Improving management of needle distress during the journey to dialysis through psychological education and training—the INJECT study feasibility pilot protocol

Outcome domain Evaluation measures
Primary outcome
 Patient feasibility/acceptability of the intervention • Patient INJECT evaluation survey: evaluates the feasibility and acceptance of the intervention, identifies which components were most useful or desired (Additional file 4). Self-devised survey uses a 5-point scale (1 = very unsuccessful, 5 = very successful and 1 = not at all, 5 = a lot). A higher score indicates higher success/acceptance of the intervention.
• INJECT study satisfaction survey: assesses satisfaction with the content of the online intervention and the ability to understand and utilise presented learning material (Additional file 5). Self-devised survey uses a 5-point scale (1 = disagree, 5 = agree). A higher score indicates greater satisfaction.
• Engagement measures:
(i) The reach (i.e. proportion of participants who were approached who then agreed to take part in the study)
(ii) Retention rates
(iii) Completion rates
(iv) Online module metrics and analytics—average time spent on page, time to completion of modules, engagement with comments section of platform
(v) Reporting to project officer during the study period
Semi-structured interviews with study participants to describe their experiences and preferences
Secondary outcomes
 Measures of needle distress • Blood/Injection Fear Scale (BIFS) obtains specific information on physiological symptoms of anxiety [33]. The scale measures fear of blood/injection on a 5-point scale (1 = strongly agree, 5 = strongly disagree). Lower score indicates higher level of fear. Chronic disease patients’ data for reliability and validity: Cronbach’s α 0.98
• Managing Needle Distress Questionnaire (MNDQ), a self-devised questionnaire to assess patient’s distress (Additional file 6). Self-devised unvalidated survey measures distress on a 5-point scale (1 = agree, 5 = disagree). A higher score indicates greater distress.
• Dialysis Fear of Injection Questionnaire (DFIQ) assesses a change in managing needle distress [9]. It measures fear of injection on a 4-point scale (0 = almost never, 3 = almost always). Renal data for reliability and validity: sensitivity 0.88, specificity 0.72, Cronbach’s α 0.87.
 Measure of distress Hospital Anxiety & Depression Scale (HADS), a standardised tool for measuring anxiety and depression [34]. The scale consists of 2 subscales: anxiety and depression. Each subscale has 7 items with a score of 0 to 21. A higher score indicates greater anxiety/depression. Renal data for reliability and validity: sensitivity 0.81, specificity 0.90, Cronbach’s α 0.85.
 Cannulation outcomes (vascular access/clinical outcomes) • Collected from the hospital electronic system as
- Missed cannulations—i.e. missed veins in the initial attempt or subsequent attempt(s) of needling (at each dialysis session for the duration of the study)
- Access surgical interventions (at each dialysis session for the duration of the study)
 Acceptability and evaluation of nursing education program Surveys administered before and after the education to evaluate self-rated knowledge about cannulation practices, confidence in managing patients with needle distress, and ability to support patients participating in INJECT. Self-devised unvalidated survey with scores 1 (disagree) to 5 (agree). Higher score indicates greater knowledge/confidence/abilities.
Semi-structured interviews with dialysis nurses to describe their experiences and preferences