Table 1.

Included instruments, studies and characteristics of patients

Instrument	Study/ies	Purpose	Participants and demographics	Exclusion criteria	Administration during testing	Description of pain related disorders	Description of opioid therapy
Instruments assessing safety, efficacy and misuse
Prescribed Opioids Difficulties Scale (PODS)	Banta-Green et al 2010	Develop instrument to assess difficulties with chronic opioid therapy as perceived from patients’ perspectives, based on 2 expected domains: psychosocial problems attributed to opioids and concerns about control of opioid medications	1144 patients on chronic opioids enrolled in Group Health for at least 1 year; age range 21–80; %female=61; %white=84; %employed=39	Cancer diagnosis	Telephone survey, trained interviewer; time unpublished	Most bothersome pain problem in past 3 months: back pain 29.6%; widespread/multiple 25.4%; leg 19.6%. Reporting 2+ pain problems in the past 6 months: 98.0%.	Average daily dose in year prior (mg/d): 0–49 (33.8%); 50–99 (33.7%); ≥100 (32.5%). Most frequently used opioids in the past 3mo: long- acting morphine (24.7%); hydrocodone (20.2%); oxycodone (16.9%); long-acting oxycodone (16.1%); methadone (10.0%).
	Sullivan et al 2010	Assess psychosocial difficulties patients attribute to use of opioid medications using the PODS	1144 patients on chronic opioids enrolled in Group Health for at least 1 year; age range 21–80; %female=63; %white=83; %employed=45	Cancer diagnosis	Telephone survey, trained interviewer; time unpublished	Most bothersome pain problem in past 6 months: back pain 28.9%; widespread/multiple 20.0; leg 24.5. Reporting 2+ pains in last 6 months: 98.3%.	Average daily dose in year prior (mg/d): 0–49 (74.2%); 50–99 (15.0%); ≥100 (10.8%). Most frequently used opioids in past 3 months: hydrocodone combination (34.9%); oxycodone (21.6%); long-acting morphine (16.7%); long-acting oxycodone (8.5%); codeine combination (5.2%).
Pain Assessment and Document- ation Tool (PADT)	Passik et al 2004	Develop a charting tool focused on outcomes in pain treatment	366 patients on opioids from both primary care and pain specialty; mean age not reported; %female=64; %white=84; %employed=29	None published	Clinician administered; alpha version (59 items) took 10–20 minutes to complete	Not published	Not published
Instruments assessing two contents areas (safety and misuse or efficacy and misuse)
Current Opioid Misuse Measure (COMM)	Butler et al 2007	Develop an assessment tool to monitor misuse of opioids among patients on chronic opioid therapy	227 patients on opioids from 3 pain specialty practices; mean age=41; %female=62; %white=83; %employed=not published	Cancer diagnosis Serious psychiatric impairment	Patient self- administered; time unpublished	Pain intensity 0–10, past 24 hours: worst 7.3 (SD = 2.1); least 4.5 (SD = 2.2); average 5.9 (SD = 1.8); current 5.8 (SD = 2.2). Pain interference (0–10): general activity 6.5 (SD = 2.6); mood 5.1 (SD = 2.7); walking 6.1 (SD = 3.0); normal work 7.2 (SD = 2.6); relations with others 4.0 (SD = 3.2); sleep 6.3 (SD = 3.1); enjoyment of life 6.2 (SD = 3.0).	Years taking opioids: mean 5.7 (SD = 9.2; range 5 months-66 years)
	Butler et al 2010	Validate the COMM in a new population	226 patients on opioids from 3 pain specialty practices; mean age=52; %female=48; %white=83; %employed=not published	None published	Patient self- administered; time unpublished	Pain intensity 0–10, past 24 hours: worst 7.0 (SD = 2.3); least 4.5 (SD = 2.4); average 5.9 (SD = 1.9); current 5.5 (SD = 2.3). Pain interference (0–10): general activity 5.9 (SD = 2.6); mood 4.6 (SD = 2.9); walking 5.9 (SD = 3.1); normal work 6.7 (SD = 2.9); relations with others 3.8 (SD = 3.1); sleep 5.9 (SD = 3.0); enjoyment of life 6.0 (SD = 3.1).	Years taking opioids: mean 5.4 (SD=5.8; range 1 mo-38 years)
	Meltzer etal 2010	Validate the COMM in a primary care sample; Test COMM against measure of prescription drug use disorder	238 patients on opioids from the primary care clinics of an urban, academic medical center; mean age=47; %female=56; %white=20; %employed=not published	None published	Designed to be patient self- administered but may have been interviewer administered; time unpublished	Chronic pain, defined as 3 months or greater based on chart review	15% of the subjects received the equivalent of 20 tablets of 5 mg oxycodone in <2 fills; 12.6% received 21–60 tablets in ≤3 fills; 22.7% received 61–150 tablets in ≤3 fills; and 49.6% received >150 tablets or >3 fills of any amount (eg, 4 prescriptions of 20 tablets each). The majority in the last category received >6 fills.
Prescription Drug Use Question- naire – patient version (PDUQ-p)	Compton et al 2008	Adapt the Prescription Drug Use Questionnaire to be patient- administered; assess predictive validity of PDUQp	135 patients on opioids in pain specialty setting; mean age=53; %female=6; race/ethnicity not reported; %employed=19	Current DSM-IV- based substance use disorder diagnosis	Patient self- administered; time unpublished	104 participants had a primary musculoskeletal pain problem, 26 neuropathic pain problem, 5 had multicategory or unclear pain problems. 75% reported pain was always present, 16% often present, remainder reported rare or variable pain.	Not published
	Banta- Green et al 2009	Assess psychometric properties of the PDUQp in different setting; examine factor structure of PDUQp and relationship to DSM- IV opioid abuse/ dependence diagnoses	704 patients on chronic opioids, enrolled in Group Health for at least 3 years; mean age=55; %female=62; %white=89; %employed=40	Cancer diagnosis	Telephone survey, trained interviewer; time unpublished	Not published	Filled ≥10 opioid prescriptions (excluding emergency room visits) or filled ≥120 days’ supply of opioids and ≥ 6 prescriptions during 12- month period.
Modified Pain Medication Question- naire (mPMQ)	Park et al 2010	Adapt the Pain Medication Questionnaire for geriatric population	150 patients on opioids for at least a month from both primary care and pain specialty; mean age=73; %female=29; %white=51; %employed not reported	Institutionalizati on	Participants chose between self- administered and researcher administered; time unpublished	Arthritis/joint problems (84.7%); back problems (76.0%); ] type II diabetes (38.0%); headaches (37.3%); dental problems (36.0%); heart disease (34.7%); cancer (22.7%); osteoporosis (19.3%), stroke (8.0%). Other disorders reported by ≤ 9 participants included fractures, fibromyalgia, and type I diabetes.	Oxycodone plus acetaminophen (34.7%); oxycodone (26.7%); sustained-release morphine (13.3%); tramadol (12.7%); sustained release oxycodone (8.7%), and hydrocodone plus acetaminophen (8.0%). Other medications reported by ≤ 6 participants: propoxyphene, propoxyphene with acetaminophen, hydromorphone, fentanyl patches, and methadone.
Instruments assessing one content area (safety or misuse)
Prescription Opioid Misuse Index (POMI)	Knisely etal 2008	Assess a brief interview focused on prescription use behaviors	74 patients on opioids; 40 from addiction treatment, 34 from pain specialty; mean age=38; % female=45; %white=95; %employed not reported	None published	Trained interviewer; time unpublished	Not published	All patients currently or recently taking OxyContin
Bowel Function Index (BFI)	Rentz et al 2009	Evaluate the psychometric characteristics of the BFI in patients with opioid-induced constipation	985 patients on opioids; referral source not reported; mean age=57; % female=61; %white not reported; %employed not reported	Current alcohol or drug abuse or acute medical illness	Clinician administered; time unpublished	All patients had moderate to severe chronic pain	All patients were taking sustained release oxycodone per study protocol
	Rentz et al 2011	Assess the psychometric properties of the BFI with respect to patient-reported outcomes in opioid- induced constipation	131 patients on opioids; referral source not reported; mean age=64; % female=66; %white=99; %employed not reported	Cancer; rheumatoid arthritis; significant structural abnormalities of GI tract; severe psychiatric co- morbidity	Patient- administered; time unpublished	All patients had chronic noncancer pain	All patients were on around-the-clock opioids
Patient Assessment of Consti- pation Symptoms (PAC-SYM)	Slappendel et al 2006	Evaluate the reliabililty, validity and responsiveness of PAC-SYM in assessing opioid- induced constipation	680 patients on opioids; referral source not reported; mean age=54; %female=61; %white not reported; %employed not reported	Strong opioid treatment in the four weeks before the study; chest disease, renal dysfunction; skin diseases that might affect transdermal delivery; history of alcohol or substance abuse; another chronic pain disorder in addition to chronic low back pain; life- limiting illness	Not reported	Cause of low back pain: Mechanical (83%); inflammatory (8%); post-surgical/trauma (39%); metabolic (1%); other (3%)	All patients were on fentanyl transdermal reservoir or oral sustained-release morphine per study protocol
Bowel Function Diary (BF- Diary)	Camilleri 2010	Evaluate the psychometric properties of the BF- Diary for assessing opioid-induced constipation and qualify the BF-Diary for use in research	238 patients on opioids; referral source not reported; mean age=54; % female=58; %white=not reported; %employed not reported	treated with opioids during 14 days before baseline; history of constipation- related bowel dysfunction or opioid abuse; reported constipation at baseline	Patient- administered via electronic device	Osteoarthritis (68 %); low back pain (53 %)	All patients were on opioids