Development and feasibility of a sex- and gender-sensitive primary care intervention for patients with chronic non-cancer pain receiving long-term opioid therapy (GESCO): a study protocol

Table 2 Patient-centered clinical outcomes

Outcome	Measure	Data collection	Date of data collection
Outcome	Measure	Data collection	t0	t1	t2
Pain	Pain history and progression (German Pain Questionnaire [58])	Self-assessment, completed by patient	x		x
Pain	10-point-pain scale (three scales: acute pain, average pain during the last 4 weeks, and strongest pain within the last 4 weeks)	Telephone interview with patient, conducted by study nurse	x	x	x
Mental well-being	Depression-Anxiety-Stress Scale (DASS) [59]	Self-assessment, completed by patient	x		x
Mental well-being	The Marburg questionnaire on habitual well-being (FW7) [60]
Quality of life	Veterans RAND 12-Item Health Survey (VR-12) [61]
Pain medication	Self-reported medication	Telephone interview with patient, conducted by study nurse	x	x	x
Pain medication	German, nationally standardized medication plan	Assessed by treating physician	x	x	x
Adverse effects of medication	Self-reported adverse effects	Telephone interview with patient, conducted by study nurse	x		x
Satisfaction with information about medication	Satisfaction with Information about Medicines Scale (SIMS) [62, 63]
Potential opioid medication misuse	Pain Medication Questionnaire (PMQ) [64]
Perceived stigma due to pain	Internalized Stigma of Chronic Pain (ISCP) [65]^a
Disruption of daily life due to pain	Pain Disability Index (PDI) [66]
Optimism/pessimism	Optimism–Pessimism Short Scale 2 (SOP2) [67]

ISSN: 2055-5784