The efficacy and cost effectiveness of N of 1 studies with diclofenac compared to standard treatment with nonsteroidal antiinflammatory drugs in osteoarthritis.
Bibliographic record
Abstract
OBJECTIVE: To determine whether or not N of 1 trials with diclofenac/misoprostol (Arthrotec) are superior and cost-effective compared with standard treatment in osteoarthritis (OA). METHODS: We randomized subjects with OA who were "uncertain that nonsteroidal antiinflammatory drugs (NSAID) were helpful" to 2 different groups. One group received conventional treatment whereby they were told to stop their NSAID and to wait and see what happened. If necessary, treatment with other NSAID and all other usual OA treatment strategies were used. The other group received a series of crossover trials with diclofenac 50 mg and misoprostol 200 micro g twice a day or an identical placebo for 2 weeks each in a random double-blinded manner. Every 4 weeks they chose which treatment they preferred. By 3 months, if there was no clear preference, the N of 1 trials were discontinued. All trial participants were seen monthly for 3 months and at 6 months. All costs (direct and indirect) were collected for both groups. Costs of research-generated visits were not counted in the "conventional treatment" group. RESULTS: Fifty-one subjects were randomized (stratified by most symptomatic OA area): 25 with knee, 7 with hip, and 19 with hand OA. Twenty-four were randomized into the N of 1 group. There were no differences in the baseline and followup variables including age, income, education, past and current NSAID use, global assessment, Health Assessment Questionnaire (HAQ), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Medical Outcome Study Short Form-36 (SF-36) scores. In the N of 1 group, 11 patients preferred diclofenac in total (of whom 7 did only one round, 2 did 2 rounds, and 2 did 3 rounds). None of the N of 1 patients preferred placebo and 11 had no preference (2 dropped out at baseline). At 6 months, 15 of 19 in "conventional therapy" and 17 of 21 in N of 1 were taking NSAID. That is, NSAID appeared to be effective in 81% of N of 1 subjects and 79% of conventionally treated patients, even though subjects were initially uncertain that their NSAID were helpful. The total OA-related costs in Canadian dollars per patient (in 1996) for N of 1 treated patients at 6 months were: 551.66 dollars +/- 154.02 dollars (SD) versus 395.62 dollars +/- 226.87 dollars for controls, excluding 2 research visits for controls (p < 0.009). The HAQ pain and disability, WOMAC scales, and physician global assessments improved more in the N of 1 group (at greater cost), but no between-group differences in efficacy were seen, possibly due to small numbers. CONCLUSION: N of 1 trials were time-consuming in these patients and are more expensive, but with slightly better outcomes. In addition, NSAID seem to be effective in a majority of subjects with OA who have been uncertain of their benefit.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".