Design, recruitment outcomes, and sample characteristics of the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial

Krebs, Erin E.; Jensen, Agnes; Nugent, Sean; DeRonne, Beth; Rutks, Indulis; Leverty, David; Gravely, Amy; Noorbaloochi, Siamak; Kroenke, Kurt

doi:10.1016/j.cct.2017.09.003

Cited by 20 publications

(20 citation statements)

References 64 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…2,3,8 These qualitative findings are also consistent with quantitative prerandomization perceptions of the 2 treatment arms in SPACE; overall, participants reported perceiving opioids as substantially more effective and somewhat less safe than nonopioid medications. 21…”

Section: Discussionmentioning

confidence: 99%

“…Informed consent was obtained from all participants. See Krebs et al 21 for a detailed study protocol, recruitment outcomes, and participant characteristics. Of 240 patients who were randomized, 234 completed the study, and all but 1 patient received medication treatment in their assigned study group.…”

Section: Methodsmentioning

confidence: 99%

“…The Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial was a pragmatic trial comparing the benefits and harms of opioid versus nonopioid medication therapy over 12 months for patients with chronic back pain or hip or knee osteoarthritis pain. 21 Main SPACE trial results indicated that opioid therapy did not differ from nonopioid therapy on the primary outcome of pain-related function over 12 months, although most patients in both treatment groups experienced improved function from baseline to the 12-month follow-up. Additionally, nonopioid medications were significantly better than opioids on pain intensity and tolerability outcomes.…”

mentioning

confidence: 93%

See 2 more Smart Citations

“I Was a Little Surprised”: Qualitative Insights From Patients Enrolled in a 12-Month Trial Comparing Opioids With Nonopioid Medications for Chronic Musculoskeletal Pain

Matthias

Donaldson

Jensen

et al. 2018

The Journal of Pain

Self Cite

View full text Add to dashboard Cite

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

mentioning

confidence: 93%

See 1 more Smart Citation

“I Was a Little Surprised”: Qualitative Insights From Patients Enrolled in a 12-Month Trial Comparing Opioids With Nonopioid Medications for Chronic Musculoskeletal Pain

Matthias

Donaldson

Jensen

et al. 2018

The Journal of Pain

Self Cite

View full text Add to dashboard Cite

show abstract

“…Comparative Effectiveness (SPACE) trial (NCT01583985). 16 In the SPACE trial, patients with chronic back or lower extremity osteoarthritis pain with moderate-severe intensity were recruited…”

Section: Sample 2 Included 240 Participants In the Strategies For Prementioning

confidence: 99%

Comparative Responsiveness of the PROMIS Pain Interference Short Forms With Legacy Pain Measures: Results From Three Randomized Clinical Trials

Chen

Kroenke

Stump

et al. 2019

The Journal of Pain

Self Cite

View full text Add to dashboard Cite

 The PROMIS Pain Interference short forms are responsive to change. Their responsiveness are comparable to legacy pain measures. Responsiveness may vary based on the sample and the direction of change. ABSTRACTThe PROMIS Pain Interference (PROMIS-PI) scales are reliable and publicly accessible; however, little is known about how responsive they are to detect change in clinical trials and how their responsiveness compares to legacy measures. The study purpose was to evaluate responsiveness for the PROMIS-PI scales and to compare their responsiveness with legacy pain measures. We used data from three clinical trials totaling 759 participants. The clinical trials included patients with chronic low back pain (n= 261), chronic back or osteoarthritis pain (n ACCEPTED MANUSCRIPT A C C E P T E D M A N U S C R I P T 2 = 240), and a history of stroke (n= 258). At both baseline and follow-up, participants completed PROMIS-PI scales and legacy pain measures (Brief Pain Inventory Interference scale, Pain/Enjoyment/General Activity (PEG) scale, SF-36 Bodily Pain scale, and Roland-Morris Disability Questionnaire). We measured global ratings of pain change, both prospectively and retrospectively, as anchors to identify patients as improved, unchanged, or worsened. Responsiveness was assessed with standardized response means, statistical tests comparing change groups, and area-under-curve analysis. The PROMIS-PI scales had largely comparable responsiveness with the Brief Pain Inventory Interference scale and PEG. The four PROMIS-PI short forms had comparable responsiveness. For all pain questionnaires, responsiveness varied based on the study population and whether pain improved or worsened. Perspective: This paper presents (1) how responsive the PROMIS Pain Interference scales were to detect change over time in the context of three clinical trials and (2) how their responsiveness compared to legacy pain measures. The findings can help researchers and clinicians choose between different patient-reported pain outcome measures.

show abstract

“…Evidence for the long‐term effectiveness of opioids from randomized placebo‐controlled trials is lacking (Chou et al, ). A recent trial with 12‐month follow‐up found opioids were no more effective than non‐opioid analgesics for chronic back pain and osteoarthritis (Krebs et al, ). However, limited evidence from open‐label studies (Hauser, Bernardy, & Maier, ), combined with clinical experience and expert consensus suggests some patients may benefit from opioids in a multifaceted pain management strategy (O'Brien et al, ).…”

Section: Introductionmentioning

confidence: 99%

Risk of adverse events in patients prescribed long‐term opioids: A cohort study in the UK Clinical Practice Research Datalink

Bedson

Chen

Ashworth

et al. 2019

European Journal of Pain

View full text Add to dashboard Cite

Background Long‐term opioid prescribing for musculoskeletal pain is controversial due to uncertainty regarding effectiveness and safety. This study examined the risks of a range of adverse events in a large cohort of patients prescribed long‐term opioids using the UK Clinical Practice Research Datalink. Methods Patients with musculoskeletal conditions starting a new long‐term opioid episode (defined as ≥3 opioid prescriptions within 90 days) between 2002 and 2012 were included. Primary outcomes: major trauma and intentional overdose (any). Secondary outcomes: addiction (any), falls, accidental poisoning, attempted suicide/self‐harm, gastrointestinal pathology and bleeding, and iron deficiency anaemia. “Control” outcomes (unrelated to opioid use): incident eczema and psoriasis. Results A total of 98,140 new long‐term opioids users (median age 61, 41% male) were followed for (median) 3.4 years. Major trauma risk increased from 285 per 10,000 person‐years without long‐term opioids to 369/10,000 for a long‐term opioid episode (<20 mg MED), 382/10,000 (20–50 mg MED), and 424/10,000 (≥50 mg MED). Adjusted hazard ratios were 1.09 (95% CI; 1.04, 1.14 for <20 mg MED vs. not being in an episode of long‐term prescribing), 1.24 (95% CI; 1.16, 1.32: 20–50 mg MED) and 1.34 (95% CI; 1.20, 1.50: ≥50 mg MED). Significant dose‐dependent increases in the risk of overdose (any type), addiction, falls, accidental poisoning, gastrointestinal pathology, and iron deficiency anaemia were also found. Conclusions Patients prescribed long‐term opioids are vulnerable to dose‐dependent serious adverse events. Opioid prescribing should be reviewed before long‐term use becomes established, and periodically thereafter to ensure that patients are not being exposed to increased risk of harm, which is not balanced by therapeutic benefit. Significance Long‐term opioid use is associated with serious adverse events such as major trauma, addiction and overdose. The risk increases with higher opioid doses. Opioid prescribing should be reviewed before long‐term use becomes established, and periodically thereafter to assess ongoing effectiveness.

show abstract

Design, recruitment outcomes, and sample characteristics of the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial

Cited by 20 publications

References 64 publications

“I Was a Little Surprised”: Qualitative Insights From Patients Enrolled in a 12-Month Trial Comparing Opioids With Nonopioid Medications for Chronic Musculoskeletal Pain

“I Was a Little Surprised”: Qualitative Insights From Patients Enrolled in a 12-Month Trial Comparing Opioids With Nonopioid Medications for Chronic Musculoskeletal Pain

Comparative Responsiveness of the PROMIS Pain Interference Short Forms With Legacy Pain Measures: Results From Three Randomized Clinical Trials

Risk of adverse events in patients prescribed long‐term opioids: A cohort study in the UK Clinical Practice Research Datalink

Contact Info

Product

Resources

About