the Study Focus on no Specific ConditionSPIINNCT01848704
Impact of "Spin" on the Interpretation of Results of Randomized Trials in the Field of Cancer
A study testing interpretation of the abstract in people with the Study Focus on no Specific Condition, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Randomized controlled trials (RCT) are the gold standard for therapeutic evaluation. Rapid dissemination of trial results and their translation into clinical practice is particularly important. Abstracts published or presented in conferences are a large, rapid and free method to disseminate these results. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- the Study Focus on no Specific Condition
- What is being tested?
- interpretation of the abstract
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The evaluators participating in this study were as follows:
- The "corresponding authors" of published RCTs in the field of cancer Experts of a French national grant in the field of cancer
- -investigator of trials registered in clinicaltrials.gov
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Randomized controlled trials (RCT) are the gold standard for therapeutic evaluation. Rapid dissemination of trial results and their translation into clinical practice is particularly important. Abstracts published or presented in conferences are a large, rapid and free method to disseminate these results. However, this mode of dissemination may have serious consequences for patients if abstracts are not an accurate and unbiased reflection of the trial results. Investigators have great freedom when writing their abstracts and articles: they can choose the data and decide how to present it. Consequently, they have many opportunities to shape readers' impressions of their results, that is, to add "spin" (ie, spin is a specific way of reporting to convince readers that the beneficial effect of the experimental treatment is higher than shown by the results).
Objective: To assess the impact of spin on the interpretation of results in abstracts of randomized controlled trials with non-statistically significant results in the field of cancer.
Read the detailed description
The investigators planned a RCT in which the unit of randomization is the abstract. The planning, implementation, analysis and writing of this study followed the CONSORT Statement12.
Design
The investigators performed a RCT comparing the interpretation of results in abstracts a) with and b) without spin.
- Identification of abstracts of randomized trials with spin. The investigators selected a sample of negative published RCTs (i.e. non statistically significant results) with a spin in abstract conclusion identified in previous works. Inclusion criteria were 1) RCTs with non-statistically significant primary outcome, 2) spin in the abstract conclusion.
- Abstracts' modification Selected abstracts were systematically rewritten to contain no "spin". All abstracts were presented in the same format without the names of authors, references, or the name of the journal in which it was published, and the names of treatments were masked by using generic terms.
- Assessment Abstracts were assessed by corresponding authors of randomized trials, experts of specific grants and investigator of trials registered in http://clinicaltrials.gov. Experts were invited to participate in our study. They were not informed of the objectives of our study. Each clinician was randomized to evaluate 1 abstract with or 1 abstract without spin.
- The primary endpoint was the interpretation of abstract results by participants. All readers participating in the study evaluated the abstract of randomized trial and answered the following question: Based on this abstract, do you think treatment A would be beneficial to patients?
Randomization characteristics
The randomization list was established in blocks of 30. So, each participant could evaluate 1 abstract with spin or 1 abstract with no spin.
The list and the block size were not disclosed to investigators. Allocation concealment was obtained by use of a computerized randomization system.
If a participant logged on the system but did not evaluate any abstract, the assessments were excluded and the abstracts were automatically allocated to the next participant.
Eligibility criteria
Evaluators participating in this study were as follows:
- The "corresponding authors" of published RCTs in the field of cancer. The investigators systematically searched Medline via PubMed to identify all publications of RCTs in 2012 and if needed 2011, 2010. The investigators collected all e-mails of "corresponding authors" of these items.
- Experts of a French national grant in the field of cancer All potential participants were invited by e-mail to participate in a study on the interpretation of results of abstracts of clinical trials. If they agreed to participate, they used an Internet link that gave them access to abstracts to assess.
- Investigators of trials registered in http://clinicaltrials.gov.
Intervention and comparators
Selection of abstracts with spin We selected from previous work and personnel collection13-16, 30 abstracts of 2 parallel arms negative RCTs (ie, non-statistically significant primary outcome) evaluating treatment in the field of cancer and having spin in the abstract conclusion according to a classification developed previously13. We excluded abstract with very unusual type of spin such as a focus on another study objective, with spin related only to safety, or study comparing the same treatment but with different dosage or different mode of administration or different duration of treatment. We also excluded abstract of RCTs with small sample size (<100). Abstract were numbered from 1 to 30 and were classified in two categories: 10 abstracts (numbers 11/12/14/16/20/22/24/27/28/30) with high level of spin (i.e., no acknowledgment of the non statistically significant primary outcome in the conclusion) and 20 with low level of spin.
Development of abstracts without spin The abstracts with spin were systematically rewritten without spin. One researcher rewrote each abstract according to specific guidelines described in the box. All abstracts had the same number of words +/-25. All abstracts without spin were evaluated independently by another researcher any disagreement were discussed and the abstract was modified according to the consensus reached.
Thus, for each study, the investigators had 2 versions of the abstract: 1 with spin and 1 without spin.
Abstracts with and without spin were presented in the format of the original abstract with the same typography. The names of authors, references, journal name, registration number, trial name or acronym, and article title were deleted, and the treatment names and description were systematically masked with generic terms (e.g., treatment A and comparator B). If needed some information that could help identifying the treatment were deleted.
Outcomes
Primary outcome The primary endpoint was participants' interpretation of the abstracts. All study participants evaluated each abstract. They answered the following question on a numerical scale graded from 0 (not at all likely) to 10 (very likely)
- Based on this abstract, do you think treatment A would be beneficial to patients? (answer: numerical scale from 0-10)
Secondary outcomes
The secondary endpoints were the assessment of the study quality, the study importance, the interest in reading the full text and the probability of being published. For each abstract, the participants answered the following:
- Rate the overall rigor of the study methodology? (scale 0-10)
- Rate the importance of the study (scale 0-10)
- Are you interested in reading the full article for the study described in this abstract? (scale 0-10)
- Do you think it would be interesting to run another trial evaluating this treatment? (scale 0-10)
Blinding
The primary endpoint is the interpretation of the abstract by participants. This outcome is very subjective. A recent study has shown that lack of blinding is responsible for an overestimation of treatment effect in randomized trials with subjective primary endpoints17. To minimize bias, the investigators proposed to have participants blinded to the study hypothesis. All participants were informed that they were participating in a survey on the interpretation of abstracts of clinical trials. They were not informed of the objectives and assumptions of the study before the end of the study when reporting the results.
Other data collected The investigators also collected the changes to abstracts in terms of words deleted and words added to each abstract.
Sample size
Each participant will read 1 abstract with or 1 abstract without spin. A sample of 266 assessments of abstracts is needed to show an effect size of 0.4 with primary outcome assuming a mean difference of 1 point and a common standard deviation based on a pilot study of 2.5 with a power of 90% and an alpha risk equal to 5%. Thirty abstracts with spin and 30 abstracts without spin are available. Theoretically, each abstract must be read the same number of times according to randomization group. Considering all these elements, it will be necessary to include 300 participants (150 in each arm). Each abstract will be read 5 times in each group (abstract with low level of spin will be read 200 times (100 in each group) and abstract with high level of spin will be read 100 times (50 in each group)).
Statistical analysis
Statistical analysis will be undertaken independently and blindly with use of Statistical Analysis Software (SAS) v9.3 by a statistician of the Centre for Clinical Epidemiology. A statistical analytic plan will be developed and validated before searching the database. The statistical analysis plan will be revised during the study to take into account any amendments to the protocol or any other change having an impact on the statistical analysis originally planned. All versions will be kept on file for review. A T test will be used for analysis of primary and secondary outcomes. This statistical plan can be modified according to available data. For instance, if the number of readings for a particular vignette is unbalanced in groups, a multi-level model (a mixed model for clustered data) will be used to compare adjusted means for the primary outcome measures between the 2 arms. This means that statistical analysis will be adjusted for unbalanced repartition of abstracts in each group. The same model will be applied to secondary outcomes and to the subgroup abstracts with high level of spin.
A secondary analysis will compare the Intraclass Correlation (ICC) between readers of abstracts with spin and abstracts without spin by computing the 95% confidence interval of the difference between ICCs (by a bootstrap method).
- Conditions
- the Study Focus on no Specific Condition
- Being tested
- interpretation of the abstract
- Keywords
- spin, interpretation, bias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interpretation of the abstractBehavioural
| Study group | Role | What they receive |
|---|---|---|
| abstract with spin | Active comparator | 30 abstracts of 2 parallel arms negative RCTs (ie, non-statistically significant primary outcome) evaluating treatment in the field of cancer and having spin in the abstract conclusion according to a classification developed previously Receives: Behavioral: interpretation of the abstract |
| abstract without spin | Experimental | The abstracts with spin were systematically rewritten without spin Receives: Behavioral: interpretation of the abstract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interpretation of the Beneficial Effect of the Experimental Treatment
The primary endpoint was the interpretation of abstract results by the participants. All readers participating in the study evaluated the abstracts of randomized trials and answered the following questions: based on this abstract, do you think treatment A would be beneficial to patients? (answer: numerical scale from 0 not at all likely tp 10 very likely)
Measured: 1 month
Secondary outcomes (4)
Overall Rigor of the Study Methodology
For each abstract, the participants answered the following:
- Rate the overall rigor of the study methodology(scale 0-10)
- Rate the importance of the study (scale 0-10)
- Are you interested in reading the full text article for the study described in this abstract? (scale 0-10)
- Do you think it would be interesting to run another trial evaluating this treatment? (scale 0-10) (Numerical scale from 0 not at all likely tp 10 very likely)
Measured: 1 month
Importance of the Study
For each abstract, the participants answered the following:
•Rate the importance of the study (scale from 0 not at all likely tp 10 very likely)
Measured: 1 month
Interest in Reading Full Text
For each abstract, the participants answered the following:
•Are you interested in reading the full text article for the study described in this abstract? (scale from 0 not at all likely tp 10 very likely)
Measured: 1 month
Need for More Evidence (Run a New Trial)
For each abstract, the participants answered the following:
•do you think it would be interesting to run another trial evaluating this treatment? (scale 0-10) (answer: numerical scale from 0 not at all likely tp 10 very likely
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for the Study Focus on no Specific ConditionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- isabelle BOUTRON, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01848704
- Sponsor's protocol ID
- RAV 007
- Acronym
- SPIIN
- Status last verified
- Apr 2013
- First submitted
- 11 Apr 2013
- Last updated
- 26 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of "Spin" on the Interpretation of Results of Randomized Trials in the Field of Cancer
- ClinicalTrials.gov ID
- NCT01848704
- Acronym / sponsor ID
- SPIIN / RAV 007
- Conditions
- the Study Focus on no Specific Condition
- Keywords
- spin, interpretation, bias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 7 May 2013 (estimated)
- Results
- Posted 26 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized controlled trials (RCT) are the gold standard for therapeutic evaluation. Rapid dissemination of trial results and their translation into clinical practice is particularly important. Abstracts published or presented in conferences are a large, rapid and free method to disseminate these results. However, this mode of dissemination may have serious consequences for patients if abstracts are not an accurate and unbiased reflection of the trial results. Investigators have great freedom when writing their abstracts and articles: they can choose the data and decide how to present it. Consequently, they have many opportunities to shape readers' impressions of their results, that is, to add "spin" (ie, spin is a specific way of reporting to convince readers that the beneficial effect of the experimental treatment is higher than shown by the results).
Objective: To assess the impact of spin on the interpretation of results in abstracts of randomized controlled trials with non-statistically significant results in the field of cancer.
Detailed description
The investigators planned a RCT in which the unit of randomization is the abstract. The planning, implementation, analysis and writing of this study followed the CONSORT Statement12.
Design
The investigators performed a RCT comparing the interpretation of results in abstracts a) with and b) without spin.
- Identification of abstracts of randomized trials with spin. The investigators selected a sample of negative published RCTs (i.e. non statistically significant results) with a spin in abstract conclusion identified in previous works. Inclusion criteria were 1) RCTs with non-statistically significant primary outcome, 2) spin in the abstract conclusion.
- Abstracts' modification Selected abstracts were systematically rewritten to contain no "spin". All abstracts were presented in the same format without the names of authors, references, or the name of the journal in which it was published, and the names of treatments were masked by using generic terms.
- Assessment Abstracts were assessed by corresponding authors of randomized trials, experts of specific grants and investigator of trials registered in http://clinicaltrials.gov. Experts were invited to participate in our study. They were not informed of the objectives of our study. Each clinician was randomized to evaluate 1 abstract with or 1 abstract without spin.
- The primary endpoint was the interpretation of abstract results by participants. All readers participating in the study evaluated the abstract of randomized trial and answered the following question: Based on this abstract, do you think treatment A would be beneficial to patients?
Randomization characteristics
The randomization list was established in blocks of 30. So, each participant could evaluate 1 abstract with spin or 1 abstract with no spin.
The list and the block size were not disclosed to investigators. Allocation concealment was obtained by use of a computerized randomization system.
If a participant logged on the system but did not evaluate any abstract, the assessments were excluded and the abstracts were automatically allocated to the next participant.
Eligibility criteria
Evaluators participating in this study were as follows:
- The "corresponding authors" of published RCTs in the field of cancer. The investigators systematically searched Medline via PubMed to identify all publications of RCTs in 2012 and if needed 2011, 2010. The investigators collected all e-mails of "corresponding authors" of these items.
- Experts of a French national grant in the field of cancer All potential participants were invited by e-mail to participate in a study on the interpretation of results of abstracts of clinical trials. If they agreed to participate, they used an Internet link that gave them access to abstracts to assess.
- Investigators of trials registered in http://clinicaltrials.gov.
Intervention and comparators
Selection of abstracts with spin We selected from previous work and personnel collection13-16, 30 abstracts of 2 parallel arms negative RCTs (ie, non-statistically significant primary outcome) evaluating treatment in the field of cancer and having spin in the abstract conclusion according to a classification developed previously13. We excluded abstract with very unusual type of spin such as a focus on another study objective, with spin related only to safety, or study comparing the same treatment but with different dosage or different mode of administration or different duration of treatment. We also excluded abstract of RCTs with small sample size (<100). Abstract were numbered from 1 to 30 and were classified in two categories: 10 abstracts (numbers 11/12/14/16/20/22/24/27/28/30) with high level of spin (i.e., no acknowledgment of the non statistically significant primary outcome in the conclusion) and 20 with low level of spin.
Development of abstracts without spin The abstracts with spin were systematically rewritten without spin. One researcher rewrote each abstract according to specific guidelines described in the box. All abstracts had the same number of words +/-25. All abstracts without spin were evaluated independently by another researcher any disagreement were discussed and the abstract was modified according to the consensus reached.
Thus, for each study, the investigators had 2 versions of the abstract: 1 with spin and 1 without spin.
Abstracts with and without spin were presented in the format of the original abstract with the same typography. The names of authors, references, journal name, registration number, trial name or acronym, and article title were deleted, and the treatment names and description were systematically masked with generic terms (e.g., treatment A and comparator B). If needed some information that could help identifying the treatment were deleted.
Outcomes
Primary outcome The primary endpoint was participants' interpretation of the abstracts. All study participants evaluated each abstract. They answered the following question on a numerical scale graded from 0 (not at all likely) to 10 (very likely)
- Based on this abstract, do you think treatment A would be beneficial to patients? (answer: numerical scale from 0-10)
Secondary outcomes
The secondary endpoints were the assessment of the study quality, the study importance, the interest in reading the full text and the probability of being published. For each abstract, the participants answered the following:
- Rate the overall rigor of the study methodology? (scale 0-10)
- Rate the importance of the study (scale 0-10)
- Are you interested in reading the full article for the study described in this abstract? (scale 0-10)
- Do you think it would be interesting to run another trial evaluating this treatment? (scale 0-10)
Blinding
The primary endpoint is the interpretation of the abstract by participants. This outcome is very subjective. A recent study has shown that lack of blinding is responsible for an overestimation of treatment effect in randomized trials with subjective primary endpoints17. To minimize bias, the investigators proposed to have participants blinded to the study hypothesis. All participants were informed that they were participating in a survey on the interpretation of abstracts of clinical trials. They were not informed of the objectives and assumptions of the study before the end of the study when reporting the results.
Other data collected The investigators also collected the changes to abstracts in terms of words deleted and words added to each abstract.
Sample size
Each participant will read 1 abstract with or 1 abstract without spin. A sample of 266 assessments of abstracts is needed to show an effect size of 0.4 with primary outcome assuming a mean difference of 1 point and a common standard deviation based on a pilot study of 2.5 with a power of 90% and an alpha risk equal to 5%. Thirty abstracts with spin and 30 abstracts without spin are available. Theoretically, each abstract must be read the same number of times according to randomization group. Considering all these elements, it will be necessary to include 300 participants (150 in each arm). Each abstract will be read 5 times in each group (abstract with low level of spin will be read 200 times (100 in each group) and abstract with high level of spin will be read 100 times (50 in each group)).
Statistical analysis
Statistical analysis will be undertaken independently and blindly with use of Statistical Analysis Software (SAS) v9.3 by a statistician of the Centre for Clinical Epidemiology. A statistical analytic plan will be developed and validated before searching the database. The statistical analysis plan will be revised during the study to take into account any amendments to the protocol or any other change having an impact on the statistical analysis originally planned. All versions will be kept on file for review. A T test will be used for analysis of primary and secondary outcomes. This statistical plan can be modified according to available data. For instance, if the number of readings for a particular vignette is unbalanced in groups, a multi-level model (a mixed model for clustered data) will be used to compare adjusted means for the primary outcome measures between the 2 arms. This means that statistical analysis will be adjusted for unbalanced repartition of abstracts in each group. The same model will be applied to secondary outcomes and to the subgroup abstracts with high level of spin.
A secondary analysis will compare the Intraclass Correlation (ICC) between readers of abstracts with spin and abstracts without spin by computing the 95% confidence interval of the difference between ICCs (by a bootstrap method).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| abstract with spin | Active comparator | Behavioral: interpretation of the abstract30 abstracts of 2 parallel arms negative RCTs (ie, non-statistically significant primary outcome) evaluating treatment in the field of cancer and having spin in the abstract conclusion according to a classification developed previously |
| abstract without spin | Experimental | Behavioral: interpretation of the abstractThe abstracts with spin were systematically rewritten without spin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- The "corresponding authors" of published RCTs in the field of cancer Experts of a French national grant in the field of cancer
- -investigator of trials registered in clinicaltrials.gov
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interpretation of the abstract | Behavioural | abstract with spin, abstract without spin |
Primary outcome
Interpretation of the Beneficial Effect of the Experimental Treatment
Time frame: 1 month
The primary endpoint was the interpretation of abstract results by the participants. All readers participating in the study evaluated the abstracts of randomized trials and answered the following questions: based on this abstract, do you think treatment A would be beneficial to patients? (answer: numerical scale from 0 not at all likely tp 10 very likely)
4 secondary outcomes
Overall Rigor of the Study Methodology
Time frame: 1 month
Importance of the Study
Time frame: 1 month
Interest in Reading Full Text
Time frame: 1 month
Need for More Evidence (Run a New Trial)
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
isabelle BOUTRON, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interpretation of the abstract in people with the Study Focus on no Specific Condition, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interpretation of the Beneficial Effect of the Experimental Treatment (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.