This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Survey of Osteoarthritis Real World Therapies (MK-0663-140) (NCT01294696), a registered phase not stated study. The primary outcome is Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Baseline.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01294696 |
| Phase | Phase not stated |
| Condition | Osteoarthritis |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 1261 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Organon and Co |
| Results posted | Yes |
2. Clinical Question
Population
Participants had osteoarthritis of the knee or knees and were treated with oral or topical analgesics for their symptoms. The primary endpoint population was defined as participants with an available Brief Pain Inventory (BPI) value at baseline. The registry lists enrollment of 1261, but the number with an available baseline BPI value is not reported in the registry record.
Intervention
The intervention is described as standard care for knee osteoarthritis. Participants were to receive treatment according to standard medical guidelines or the investigating physician’s usual clinical practice. The record does not identify a specific analgesic regimen or a treatment assignment protocol.
Comparator
No randomized comparator is described. The record presents participants grouped by whether they reported adequate or inadequate pain relief at baseline; these groups are not like-for-like treatment arms. Allocation is not stated, and a separate control group is not reported in the registry record.
Primary question
At baseline, what proportion of participants reported adequate rather than inadequate relief of knee osteoarthritis pain? Adequate control was defined using the average-pain item of the BPI as a score of 4 or lower; inadequate control was a score above 4. The study also aimed to characterize pain during a 12-month follow-up period, but numerical results for the primary endpoint and pain follow-up are not reported in the registry record.
The study is framed as a description of reported pain relief among people receiving real-world care, rather than as a test of whether one treatment is better than another. The baseline classification uses each participant’s report of average pain over the last week. The registry also lists outcomes on adequate relief from joint stiffness or limitation in physical function at baseline and during follow-up. Without numerical outcome results, the record does not establish how common adequate pain relief was or how reports changed over time.
3. Trial Design
The Survey of Osteoarthritis Real World Therapies (SORT) is a study of people with knee osteoarthritis receiving usual clinical care. The registry lists Organon and Co as the sponsor and describes the intervention as standard care for knee osteoarthritis. Participants were to be treated according to standard medical guidelines or the investigating physician’s usual clinical practice. Specific medicines, treatment selection rules, or treatment changes are not reported in the registry record.
The study began in 2010-10, had a primary completion date of 2013-01, and is listed as completed. Enrollment is recorded as 1261. That enrollment figure does not establish how many participants contributed to each outcome: the primary outcome population was defined as participants with an available baseline BPI value, and the number meeting that definition is not reported in the registry record.
The primary outcome was the percentage of participants reporting adequate versus inadequate pain relief at baseline, measured on Day 1. Pain was assessed with the BPI, which asks participants to rate pain due to osteoarthritis in the affected knee over the last week. The study summary also describes an aim to characterize pain over a 12-month follow-up period. Secondary outcomes concern adequate relief from joint stiffness or limitation in physical function at baseline and Month 1, Month 3, Month 6, Month 9, and Month 12.
The registry does not describe a randomized comparison; allocation is not stated. The baseline pain-relief categories are outcome-defined groups, not treatment assignments. This design can describe reported symptoms and care in the study population, but it does not by itself provide a randomized estimate of a treatment effect. The registry record does not report a detailed protocol, a statistical analysis plan, or numerical primary outcome results.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | All Enrolled Participants |
|---|---|
| STARTED | 1261 |
| COMPLETED | 1187 |
| NOT COMPLETED | 74 |
Reasons for not completing this period:
| Reason | All Enrolled Participants |
|---|---|
| Screening failures | 7 |
| Protocol Violation | 8 |
| Missing BPI Response | 7 |
| Site closure | 52 |
Analysis population for the primary outcome, as defined in the registry: The population consisted of all participants for which a BPI value was available at baseline.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Participants With Adequate Pain Relief | Participants With Inadequate Pain Relief | Total |
|---|---|---|---|---|
| Participants analysed | 548 | 639 | 1187 | |
| Age, Continuous | Years | 67.6 (SD 9.03) | 68.0 (SD 9.76) | 67.8 (SD 9.43) |
| Sex: Female, Male: Female | Participants | 329 | 479 | 808 |
| Sex: Female, Male: Male | Participants | 219 | 160 | 379 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Baseline, measured over Baseline (Day 1).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Percentage of Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of participants classified as having adequate or inadequate pain relief at baseline. The classification is based on question 5 of the Brief Pain Inventory (BPI), which asks participants to rate their average pain due to osteoarthritis in the affected knee during the last week. The response scale runs from 0, meaning no pain, to 10, meaning the worst pain imaginable. A score of 4 or lower was defined as adequate pain control; a score above 4 was defined as inadequate control.
This measure is used to describe the distribution of participants’ reported pain control at the start of the study. It captures the participant’s experience rather than an objective measure of joint disease or a clinician’s judgment. The registry defines the primary analysis population as participants with a BPI value available at baseline. The number with such a value and the percentages in the adequate and inadequate categories are not reported in the registry record.
The endpoint is descriptive. Because the record does not report random assignment to treatments or a separate control group, a difference between these baseline categories would not be an estimate of the effect of one treatment compared with another. The registry summary also describes follow-up of pain over 12 months, while the listed secondary outcomes address adequate relief from joint stiffness or limitation in physical function at specified follow-up visits. Numerical results for those outcomes are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The study asks a descriptive question: how many participants with knee osteoarthritis reported adequate or inadequate pain relief at baseline while receiving care in ordinary clinical practice? The BPI definition makes the category boundary explicit, with adequate relief defined as a score of 4 or lower on the average-pain item and inadequate relief as a score above 4. However, the registry record does not report the primary endpoint percentages. As a result, the prevalence of either category cannot be read from the posted results.
Enrollment is listed as 1261, but that figure should not be treated as the denominator for the primary endpoint. The primary population is defined by baseline BPI availability, and the number with an available value is not reported in the registry record. Nor are missing baseline values, outcome-specific denominators, or numerical estimates for pain at follow-up reported. Without those details, readers cannot determine the extent to which the recorded outcomes represent everyone enrolled or only participants with available measurements.
The study’s baseline categories are not randomized treatment groups. Participants were treated according to usual medical guidelines or the investigating physician’s clinical practice, and allocation is not stated. The available record therefore does not support a causal comparison of treatments. Any differences between people classified as having adequate and inadequate pain relief could reflect differences in their symptoms or other characteristics; adjusted comparisons and methods for addressing such differences are not reported in the registry record.
The record lists secondary outcomes for adequate relief from joint stiffness or limitation in physical function at baseline and at Month 1, Month 3, Month 6, Month 9, and Month 12. The study summary describes a 12-month period for characterizing pain. These details indicate the intended timing and subject matter of follow-up, but they do not establish that outcomes improved, worsened, or remained stable. Numerical estimates and uncertainty measures are not reported in the registry record.
Serious adverse event figures are reported separately for the adequate- and inadequate-pain-relief groups. Those counts are safety descriptions, not evidence that one category or treatment caused more events. The groups are not randomized treatment arms, and the record does not provide a comparative safety analysis. Interpretation should therefore remain limited to the counts and event terms recorded, without attributing differences to a treatment.
Overall, the record documents a real-world study objective, outcome definitions, and selected safety counts, but it does not provide the numerical primary outcome results needed to quantify the central endpoint. No estimate of treatment benefit, treatment harm, or change in pain over follow-up can be drawn from the registry information.
9. Statistical Methods Explained
How is the primary outcome defined?
The primary outcome is a percentage based on a binary classification of the BPI average-pain response at baseline. Each participant with an available value is placed in the adequate-relief category when the score is 4 or lower, or the inadequate-relief category when the score is above 4. In general, a percentage describes the share of a defined group meeting a specified condition. Its interpretation depends on knowing both the count meeting the condition and the denominator to which that count applies. The registry record gives the population definition but does not report the endpoint counts, percentages, or the number with an available baseline value.
What does the BPI measure?
The BPI is a participant-reported inventory. The registry description says its questions concern osteoarthritis pain in the affected knee over the last week and includes pain at its worst, at its least, on average, and right now. The primary endpoint uses the average-pain item. This is a measure of perceived symptom severity, not a direct measurement of joint structure. Participant reports can be valuable for describing symptoms that matter to patients, but the score reflects the participant’s experience at the time and over the stated recall period.
What can a confidence interval tell a reader?
In general, a confidence interval expresses uncertainty around an estimate under the assumptions of the statistical method used. A narrower interval indicates greater precision under those assumptions, while a wider interval indicates more uncertainty. The interval does not remove limitations in study design, measurement, or missing data. Numerical confidence intervals for the primary endpoint are not reported in the registry record, so its statistical precision cannot be assessed from the record.
Why does the denominator matter?
For a percentage, the denominator identifies the group from which the percentage is calculated. Here, the primary endpoint population is participants with a baseline BPI value available. Enrollment is reported as 1261, but it is not stated that every enrolled participant had an available baseline value. Using enrollment as the endpoint denominator without that information could misrepresent the analysis. The registry record also does not report how missing BPI values were handled or whether availability differed across participant characteristics.
How should follow-up outcomes be read?
The listed secondary outcomes concern adequate relief from joint stiffness or limitation in physical function at baseline and at Month 1, Month 3, Month 6, Month 9, and Month 12. In general, repeated measurements can describe how reported outcomes vary over time. Interpretation requires knowing the number measured at each visit, the definition of each outcome, and how missing follow-up measurements were treated. Those analysis details and the numerical follow-up results are not reported in the registry record. A sequence of planned assessment times alone does not show a trend or establish a change.
What do the sample-size assumptions mean?
The record describes planning illustrations based on the observed effect, rather than the study’s own design. The stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. These are planning assumptions, not a report of the trial’s enrollment rationale or an observed-power calculation. The record does not report the observed effect used for the illustrations or numerical sample-size estimates. The illustrations therefore cannot be used to infer the study’s original sample-size justification.
In general, a sample-size calculation estimates how many participants would be needed under specified assumptions to detect a target effect with a chosen power. Such a calculation is prospective planning information. It does not describe how precisely an already completed study estimated its outcome, and it does not establish whether the study was adequately powered for outcomes that were not specified in the calculation. Any sample-size illustration should be read as conditional on its assumptions, rather than as a finding about observed outcomes.
Why do the groups not support a treatment comparison?
The adverse-event listings group participants by baseline pain-relief classification. The registry does not identify these categories as randomized treatment assignments, and it states that the record is not a randomized comparison. In general, random assignment helps make treatment groups comparable with respect to measured and unmeasured factors on average. Without a randomized treatment contrast, simple differences between groups can reflect underlying differences in participants rather than treatment effects. The registry record does not report adjusted analyses that would address this concern.
The record reports no analyses in its analysis count and does not provide a statistical plan. It is therefore not possible to establish which inferential methods, if any, were applied to the primary endpoint or secondary outcomes, whether estimates were adjusted, or how uncertainty was quantified. General statistical concepts can clarify what information would be needed, but they cannot substitute for analysis details or numerical results that are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists eight outcome measures and identifies secondary outcomes for adequate relief from joint stiffness or limitation in physical function at baseline and at Month 1, Month 3, Month 6, Month 9, and Month 12. Considering several outcomes or assessment times can create a multiplicity issue: when many statistical hypotheses are tested, the chance of at least one apparently unusual result can increase. In general, a statistical plan may address this by specifying a primary comparison, an adjustment approach, or a hierarchy of tests. The registry record does not report a multiplicity strategy or a detailed statistical analysis plan.
The record defines the primary population as participants with an available baseline BPI value. It does not report the number of participants with a value, the number missing the baseline measure, or how missing data were handled. For follow-up, the registry lists assessment times but does not report visit-specific denominators, reasons for missing measurements, imputation methods, or sensitivity analyses. Those omissions limit assessment of how complete the outcome data were and whether missingness could affect the estimates.
The registry record does not report which analysis populations were used beyond the stated baseline BPI availability definition. It is not reported whether all enrolled participants, a subset, or another defined population contributed to any secondary or safety analyses. The analysis count is 0, and numerical primary outcome estimates are not reported. Consequently, readers cannot assess the impact of multiplicity, missing data, or analysis-population choices on the reported efficacy outcomes. Those methods are not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Participants With Adequate Pain Relief | 11 | 548 | 2.0% |
| Participants With Inadequate Pain Relief | 25 | 639 | 3.9% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Participants With Adequate Pain Relief | 0 of 548 |
| Participants With Inadequate Pain Relief | 0 of 639 |
Most frequent serious adverse event terms
| Event term | Organ system | Participants With Adequate Pain Relief | Participants With Inadequate Pain Relief |
|---|---|---|---|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | 0 of 548 | 4 of 639 |
| Arthritis | Musculoskeletal and connective tissue disorders | 1 of 548 | 1 of 639 |
| Anaemia | Blood and lymphatic system disorders | 1 of 548 | 0 of 639 |
| Angina Unstable | Cardiac disorders | 0 of 548 | 1 of 639 |
| Palpitations | Cardiac disorders | 0 of 548 | 1 of 639 |
| Cataract | Eye disorders | 0 of 548 | 1 of 639 |
| Abdominal Distention | Gastrointestinal disorders | 1 of 548 | 0 of 639 |
| Diarrhoea | Gastrointestinal disorders | 0 of 548 | 1 of 639 |
| Nausea | Gastrointestinal disorders | 1 of 548 | 0 of 639 |
| Death | General disorders | 1 of 548 | 0 of 639 |
Serious events with the highest arm-level rate: osteoarthritis (0.6%), anaemia (0.2%), abdominal distention (0.2%), nausea (0.2%), death (0.2%).
The registry lists serious adverse event figures by baseline pain-relief category. For participants with adequate pain relief, the serious-event listing is 11 among 548 at risk; for participants with inadequate pain relief, it is 25 among 639 at risk. The record also lists 0 other adverse events in each group. These are safety counts as recorded, not an estimate of a causal treatment effect. The group labels describe pain-relief status, not randomized treatment assignment.
The listed serious-event terms include Osteoarthritis at 0.6%, and Anaemia, Abdominal Distention, Nausea, Death, and Oedema Peripheral at 0.2% each. The registry record does not provide enough detail to establish the event-specific denominators, the timing or duration of events, or whether events were judged related to a treatment. It also does not provide an arm-specific death count; the term listing should not be interpreted as one.
In general, safety counts need context about exposure, event definitions, follow-up, and how participants were monitored. Those details are not reported in the registry record. The figures can be read as the serious-event information recorded for the two baseline categories, but they do not show that either category caused events or that a treatment was safer.
12. What the Result Does, and Does Not, Mean
The registry record establishes that the study was designed to describe pain relief among people with knee osteoarthritis receiving usual care. It defines adequate relief using the average-pain item of the BPI and sets out the baseline population as participants with an available BPI value. It also identifies intended follow-up on pain and secondary outcomes concerning stiffness or physical-function limitations. These definitions help clarify what the study sought to measure.
The record does not report the numerical primary endpoint percentages, the endpoint denominator, or numerical follow-up results. It therefore cannot show how common adequate pain relief was in the study population or how participants’ pain reports changed over the 12-month period. A planned follow-up schedule is not itself evidence of improvement, deterioration, or stability. The outcome values and their statistical precision are not reported in the registry record.
The study also does not provide a randomized treatment comparison. Usual clinical practice is described, but specific treatment assignments are not. Baseline categories of adequate and inadequate pain relief are symptom classifications, not randomized arms. As a result, the record cannot establish that a particular analgesic or care strategy caused a difference in pain, stiffness, function, or serious adverse events.
Enrollment of 1261 is not a substitute for outcome-specific denominators. The registry defines the primary analysis population by baseline BPI availability, but does not state how many participants met that definition or how missing outcomes were handled. The listed serious adverse event counts and terms offer limited descriptive safety information, but do not support a comparative safety conclusion.
In general, a descriptive real-world study can document how symptoms and care are reported in a clinical setting. Its findings depend on who was included, which measurements were available, and how outcomes were analyzed. Those details and the numerical primary results are not reported in the registry record, so conclusions should remain limited to the study aims, definitions, and safety information that are recorded.
13. Why This Trial Matters Statistically
This study is statistically relevant because it focuses on patient-reported pain relief in routine care rather than on a randomized comparison of assigned treatments. Real-world descriptions can address how symptoms are experienced among people receiving ordinary clinical care. They also raise important interpretation questions: which participants contributed usable measurements, how symptom categories were defined, and whether observations at different visits represent comparable groups over time.
The BPI threshold gives the primary endpoint a clear operational definition. A score of 4 or lower on the average-pain item is classified as adequate relief, while a score above 4 is classified as inadequate relief. Such a threshold makes a continuous rating easier to summarize as categories, but it also means the reported percentage depends on the chosen cutoff. The underlying ratings and resulting proportions are not reported in the registry record, so the consequences of that classification cannot be evaluated from the posted results.
The study’s follow-up aims also highlight the need to distinguish intended measurement from observed evidence. The record lists outcomes at baseline and multiple visits through Month 12, but does not report numerical results or visit-specific denominators. In general, repeated outcome measurements can be affected by missing follow-up, changes in who remains under observation, and differences in treatment received during routine care. Those considerations require analysis details that are not reported in the registry record.
Finally, the record illustrates why study design and outcome reporting must be considered together. The baseline relief categories do not constitute randomized treatment arms, and the reported serious-event counts do not establish a treatment-related difference. The record documents useful definitions and study objectives, but its missing numerical primary results and analysis details prevent a quantitative assessment of the central question.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
A central limitation of the registry record is that it does not report numerical results for the primary endpoint. The primary outcome is defined as the percentage reporting adequate versus inadequate pain relief at baseline, but the category counts and percentages are absent. The number of participants with an available baseline BPI value is also not reported, so the endpoint denominator cannot be confirmed from the record.
The study is described as occurring under standard medical guidelines or the investigating physician’s usual clinical practice. Specific treatments received, treatment selection, changes in care, and exposure duration are not reported. Allocation is not stated, and the record is not a randomized comparison. Accordingly, the baseline pain-relief groups cannot be treated as randomized treatment arms, and the record does not support causal treatment comparisons.
The registry describes a 12-month follow-up aim and lists secondary outcomes at baseline and follow-up visits, but numerical outcome estimates are not reported. Visit-specific denominators, missing-data procedures, and sensitivity analyses are also not reported in the registry record. Without these details, the completeness and comparability of follow-up measurements cannot be assessed.
The record does not report the statistical analysis plan, multiplicity approach, adjusted analyses, or confidence intervals for the primary and secondary outcomes. It also does not state the original sample-size justification. The sample-size assumptions describe planning illustrations based on an observed effect, but numerical illustration results are not reported in the registry record. These limitations restrict interpretation to the study’s stated aims, outcome definitions, enrollment, and listed safety information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Survey of Osteoarthritis Real World Therapies (MK-0663-140) — NCT01294696.
- Registry record last updated 2024-08-29; status last verified 2022-02.
- Results first posted 2014-03-04.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The Survey of Osteoarthritis Real World Therapies (SORT), sponsored by Organon and Co, is listed as completed. The study began in 2010-10, had a primary completion date of 2013-01, and recorded enrollment of 1261. It concerned osteoarthritis of the knee or knees and described treatment according to standard medical guidelines or the investigating physician’s usual clinical practice.
The primary outcome was adequate versus inadequate pain relief at baseline, defined using the average-pain item of the BPI. The primary population was participants with an available baseline BPI value. The registry also lists secondary outcomes on adequate relief from stiffness or physical-function limitation at baseline and follow-up visits through Month 12.
Numerical primary and follow-up outcome results, outcome-specific denominators, missing-data methods, and a statistical analysis plan are not reported in the registry record. Serious adverse event counts are listed by baseline pain-relief category, but the record does not describe a randomized treatment comparison or provide a comparative safety analysis.