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Table 1 Study methods and instruments

From: Improving shared decision-making in advanced Parkinson’s disease: protocol of a mixed methods feasibility study

Research objectives

Components

Methods and instruments

Demographic data

Demographic data

Baseline questionnaire with questions on demographics

Acceptability

1. Satisfaction with intervention and how intervention is received

1a. Structured questionnaires for patients on items as readability, comprehensiveness, layout and amount of information

1b. Semi-structured interviews with patients, neurologists and PD nurse specialists with items on perceived satisfaction, and perceived strengths and weaknesses of the intervention

Level of implementation

1. To what extent is the intervention implemented as planned

2. To what extent were all components of the intervention used

3. How did participants react to the specific aspects of the intervention and to what extent did patients engage in the intervention

4. What proportion of the included population actually were using the intervention

1. Field notes to what extent the intervention was implemented as planned and training was provided as planned

2. Analysis of audiotapes consultations, logging data of navigation behaviour website and hard copies of value elicitation tool summary: evaluation if all elements of intervention are actually used

3a. Analysis of audiotapes consultations and logging data of navigation behaviour website to analyse if patients engage in all elements of the intervention

3b. Semi-structured interviews on the perceived interaction with the different elements of the intervention

4. Analysis of audiotapes consultations and logging data of navigation behaviour website to analyse which patients in the intervention group and professionals were using the intervention during the decision process

Small-scale efficacy testing:

- Level of SDM

1. Patient and neurologist/PD nurse perceived level of SDM

2. Researcher observed level of SDM

1. Structured questionnaires for patients and neurologists/PD nurse specialists using the following validated scales: SDMQ-9 (patients) and SDMQ-9-doc (neurologists/PD nurse specialists), CollaboRATE (patients) and CPS actual role (patients, neurologists, PD nurse specialists)

2. Analysis of the audiotaped consultations using the validated scale: OPTION-5

Small-scale efficacy testing:- Decision quality

1. Level of informed choice

2. Decisional conflict in decision-making

1. Measuring knowledge in patients at the start and end of decision-making process using questionnaire with 20 questions on the advanced treatments

2. Structured questionnaires for patients and neurologists/PD nurse specialists using the following validated scales: DCS (patients) and PDPAI (neurologists/PD nurse specialists)

Feasibility of study procedures

1. Recruitment

2. Potential outcome indicators

3. Approaches to data collection

1a. Field notes on study inclusion rate, drop-out rates

1b. Semi-structured interviews with neurologists and PD nurse specialists with items such as barriers to recruitment

2. Analysis of outcome measures from the small-scale efficacy testing with evaluation of conflicting data on outcome measures

3. Semi-structured interviews with patients and neurologists/PD nurse specialists with items on acceptability of the logistics/practicability of the study procedures

Context

1. Patient-related factors in the implementation and outcomes

2. Professional-related factors in the implementation and outcomes

3. Organisational context

1a. Structured questionnaires for patients with items on preferred role in decision-making (CPS), treatment preference, pre-knowledge, health literacy skills (FCHHL) and mood (HADS)

1b. Cognitive testing using MoCA, BSAT, Verbal Fluency, Stroop Color Word Test, National Adult Reading Test, Raven Advanced Progressive Matrices and MMSE

2. Structured questionnaires for neurologists and PD nurse specialists with items on their role in decision-making (CPS), treatment preference and level of experience with treatments

3. Field notes on national consensus of treatment of advanced PD, organisational structure for this specific decision in participating centres

  1. CPS control Preference Scale, FCCHL Functional Communicative and Critical Health Literacy, HADS Hospital Anxiety and Depression Scale, MoCA Montreal Cognitive Assessment, BSAT Brixton Spatial Anticipation Test Provider Decision Process Assessment Instrument, MMSE Mini Mental State Examination, PDPAI Provider Decision Process Assessment Instrument