No need for rescue medication (NNR) as an easily interpretable efficacy outcome measure in analgesic trials: validation in an individual-patient meta-analysis of dental pain placebo-controlled trials of naproxen

Li-Wan-Po, Alain; Chen, S.; Petersen, B.; Wang, Y.

doi:10.1111/jcpt.12019

Cited by 2 publications

(2 citation statements)

References 16 publications

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“…Other outcomes looked for were as follows: Patients reporting a global evaluation as “very good” or “excellent” on a five-point categorical global scale with the wording “poor, fair, good, very good, or excellent” Patients using rescue medication within a particular time [ 34 ] Patients with any adverse event, any serious adverse event (as reported in the study), and withdrawal due to an adverse event …”

Section: Methodsmentioning

confidence: 99%

Diclofenac Potassium in Acute Postoperative Pain and Dysmenorrhoea: Results from Comprehensive Clinical Trial Reports

Moore

Derry

2018

Pain Research and Management

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We compared the efficacy of diclofenac potassium in unpublished clinical study reports (CSRs) and published reports to examine publication bias, industry bias, and comprehensiveness. Novartis provided CSRs of randomised double-blind trials of diclofenac potassium involving postoperative patients following third molar extraction (3 trials, n=519), gynaecological surgery (3 trials, n=679), and dysmenorrhoea (2 trials, n=711) conducted in 1988–1990. Searches identified published reports of 6 trials. Information from 599/1909 patients was not published; trials with 846/1909 patients were published in a defunct journal. Greater methodological information in CSRs contributed to lesser risk of bias than published trials. Numbers needed to treat (NNT) from CSRs for all six postoperative trials for at least 50% of maximum pain relief over 6 h were 2.2 (95% confidence interval, 1.9–2.6) and 2.1 (1.8–2.4) for 50 and 100 mg diclofenac potassium, respectively. A Cochrane review of published trial data reported NNTs of 2.1 and 1.9, and one comprehensive analysis reported NNTs of 2.2 and 2.1, respectively. All analyses had similar results for patients remedicating within 8 h. No data from dysmenorrhoea CSRs appeared in a Cochrane review. CSRs provide useful information and increase confidence. Stable efficacy estimates with standard study designs reduce the need for updating reviews.

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Section: Methodsmentioning

confidence: 99%

Diclofenac Potassium in Acute Postoperative Pain and Dysmenorrhoea: Results from Comprehensive Clinical Trial Reports

Moore

Derry

2018

Pain Research and Management

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“…In a recent publication, Li‐Wan‐Po et al . demonstrate that ‘no need of rescue medication’ is preferable to the alternative primary outcome measure ‘50% of the maximum pain‐relief score’ because of its easier clinical interpretation (and major practical importance) in trials of minor analgesics.…”

Section: Commentmentioning

confidence: 99%

On clinical thresholds, clinical equivalents and indirect comparisons of biological treatments for moderate-to-severe psoriasis

Puig

2015

J Clin Pharm Ther

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Summary What is known and objective To assess the equivalent efficacy of two or more treatments, clinical relevance must be adequately established, but there appears to be some confusion between clinical relevance and differences in absolute risk reduction or effect size, which quantifies the size of the difference between two groups. Delta values used for sample size calculation in clinical trials should take account of clinical relevance. We aim to illustrate this confusion as regards biologics for treatment of moderate‐to‐severe psoriasis. Comment In psoriasis, treatment success has been defined as achieving lesion response to ‘clear or almost clear’, ≥ 90% improvement with respect to baseline Psoriasis Area and Severity Index (PASI), or achieving a PASI score lower than 3 on treatment. A PASI 75 response (≥ 75% improvement with respect to baseline) is often taken as a meaningful cut‐off for clinical relevance. A recently published meta‐analysis using a random‐effects model showed that ustekinumab use was associated with statistically significantly higher odds for achieving PASI 75 response compared with adalimumab use (OR, 1·84; 95% credible interval, 1·01–3·54) and etanercept use (2·07; 1·42–3·06), but lower odds for achieving PASI 75 compared with infliximab use (0·36; 0·14–0·82). The inference is that this magnitude of response in PASI will translate into a perceptible clinical improvement by patients. This need not be the case. In particular, this measure does not take account of the adverse effect profiles of the different agents. Only by taking account of these different and opposing effects, such as through use of validated quality‐of‐life indices, can one make robust inferences on clinical equivalence. What is new and Conclusion From a clinical perspective, biologics for the treatment of plaque psoriasis should not be considered equivalents solely on the basis of PASI responses. Choice between these agents requires accounting for their relative safety and efficacy profiles, as well as patient‐reported outcome measures. At the individual patient level, other factors such as individual contraindications must be taken into account.

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No need for rescue medication (NNR) as an easily interpretable efficacy outcome measure in analgesic trials: validation in an individual-patient meta-analysis of dental pain placebo-controlled trials of naproxen

Abstract: No need for rescue medication is a reliable outcome measure for use in acute pain trials. As it is more readily understandable than 50% TOTPAR, it should be the preferred primary outcome measure in acute pain trials.

Cited by 2 publications

References 16 publications

Diclofenac Potassium in Acute Postoperative Pain and Dysmenorrhoea: Results from Comprehensive Clinical Trial Reports

Diclofenac Potassium in Acute Postoperative Pain and Dysmenorrhoea: Results from Comprehensive Clinical Trial Reports

On clinical thresholds, clinical equivalents and indirect comparisons of biological treatments for moderate-to-severe psoriasis

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