Getting the “balance” right in clinical trials

Shaheed, Christina Abdel; Blyth, Fiona; Furmage, Ann-Mason; Stanaway, Fiona

doi:10.1136/bmj.n2869

Cited by 6 publications

(3 citation statements)

References 15 publications

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“…The study questionnaires will capture these details, and any therapies that may impact our study outcomes (i.e., which has the potential to provide pain relief and therefore be opioid sparing) will be documented as a cointervention. 38…”

Section: Cointerventionsmentioning

confidence: 99%

Clinical Observation, Management and Function Of low back pain Relief Therapies (COMFORT): A cluster randomised controlled trial protocol

Abdel Shaheed,

Ivers,

Vizza

et al. 2023

BMJ Open

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IntroductionLow back pain (LBP) is commonly treated with opioid analgesics despite evidence that these medicines provide minimal or no benefit for LBP and have an established profile of harms. International guidelines discourage or urge caution with the use of opioids for back pain; however, doctors and patients lack practical strategies to help them implement the guidelines. This trial will evaluate a multifaceted intervention to support general practitioners (GPs) and their patients with LBP implement the recommendations in the latest opioid prescribing guidelines.Methods and analysisThis is a cluster randomised controlled trial that will evaluate the effect of educational outreach visits to GPs promoting opioid stewardship alongside non-pharmacological interventions including heat wrap and patient education about the possible harms and benefits of opioids, on GP prescribing of opioids medicines dispensed. At least 40 general practices will be randomised in a 1:1 ratio to either the intervention or control (no outreach visits; GP provides usual care). A total of 410 patient–participants (205 in each arm) who have been prescribed an opioid for LBP will be enrolled via participating general practices. Follow-up of patient–participants will occur over a 1-year period. The primary outcome will be the cumulative dose of opioid dispensed that was prescribed by study GPs over 1 year from the enrolment visit (in morphine milligram equivalent dose). Secondary outcomes include prescription of opioid medicines, benzodiazepines, gabapentinoids, non-steroidal anti-inflammatory drugs by study GPs or any GP, health services utilisation and patient-reported outcomes such as pain, quality of life and adverse events. Analysis will be by intention to treat, with a health economics analysis also planned.Ethics and disseminationThe trial received ethics approval from The University of Sydney Human Research Ethics Committee (2022/511). The results will be disseminated via publications in journals, media and conference presentations.Trial registration numberACTRN12622001505796.

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Section: Cointerventionsmentioning

confidence: 99%

Clinical Observation, Management and Function Of low back pain Relief Therapies (COMFORT): A cluster randomised controlled trial protocol

Abdel Shaheed,

Ivers,

Vizza

et al. 2023

BMJ Open

Self Cite

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show abstract

“…There is no published guidance about how to capture and report cointerventions in clinical trials, and we agree that efforts are required to support consensus reporting of co-interventions in clinical trials. 6 These data will be reported separately in trial process evaluations (eg, economic analysis).…”

mentioning

confidence: 99%

Graded Sensorimotor Retraining and Pain Intensity in Chronic Low Back Pain

Jiao

Chen

2023

JAMA

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“…We agree with Jiao and colleagues that details of the additional treatments received by participants in each group, including other physical therapy interventions, could assist with interpretations of the trial findings. There is no published guidance about how to capture and report co-interventions in clinical trials, and we agree that efforts are required to support consensus reporting of co-interventions in clinical trials . These data will be reported separately in trial process evaluations (eg, economic analysis).…”

mentioning

confidence: 99%

Graded Sensorimotor Retraining and Pain Intensity in Chronic Low Back Pain—Reply

Cashin

Wand

McAuley

2023

JAMA

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Getting the “balance” right in clinical trials

Abstract: Co-interventions that could influence results must be recorded and reported

Cited by 6 publications

References 15 publications

Clinical Observation, Management and Function Of low back pain Relief Therapies (COMFORT): A cluster randomised controlled trial protocol

Clinical Observation, Management and Function Of low back pain Relief Therapies (COMFORT): A cluster randomised controlled trial protocol

Graded Sensorimotor Retraining and Pain Intensity in Chronic Low Back Pain

Graded Sensorimotor Retraining and Pain Intensity in Chronic Low Back Pain—Reply

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