The DOI matches its Crossref record; 16 of the 17 references it cites were found in a registry or an index; none of the 5 sources its claims cite is checked for support yet.
The role and interpretation of pilot studies in clinical research
Open accessAbstract
Pilot studies represent a fundamental phase of the research process. The purpose of conducting a pilot study is to examine the feasibility of an approach that is intended to be used in a larger scale study. The roles and limitations of pilot studies are described here using a clinical trial as an example. A pilot study can be used to evaluate the feasibility of recruitment, randomization, retention, assessment procedures, new methods, and implementation of the novel intervention. A pilot study is not a hypothesis testing study. Safety, efficacy and effectiveness are not evaluated in a pilot. Contrary to tradition, a pilot study does not provide a meaningful effect size estimate for planning subsequent studies due to the imprecision inherent in data from small samples. Feasibility results do not necessarily generalize beyond the inclusion and exclusion criteria of the pilot design. A pilot study is a requisite initial step in exploring a novel intervention or an innovative application of an intervention. Pilot results can inform feasibility and identify modifications needed in the design of a larger, ensuing hypothesis testing study. Investigators should be forthright in stating these objectives of a pilot study. Grant reviewers and other stakeholders should expect no more.
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Claims the paper makes
40 Own interpretation · 5 No basis given · 2 No full text of the sources · 1 Sources not found
None of the sources cited for this claim could be matched to a paper in Crossref, so there is nothing to check it against.
In the paper
“When event rates are reported and no adverse event is observed for a particular category, the rule of three should be applied to estimate the upper bound of the 95% CI, where the upper bound is approximately 3/n.”
§ The Role and Interpretation of Pilot Studies in Clinical Research > EXCEEDING THE LIMITATIONS OF A PILOT STUDY: WHAT PILOT STUDIES CANNOT DO > Tolerability and Preliminary Safety
What the sources say
- Not matchedcites Jovanovic & Levy, 1997
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- Not matchedcites Jovanovic et al., 1997
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Not matched
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Basing a decision to proceed or terminate evaluation of a particular intervention on pilot data is perilous because there is a very good chance that the decision will be derived from false positive or false negative results.”
§ The Role and Interpretation of Pilot Studies in Clinical Research > DISCUSSION
boosteddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Each aspect of feasibility could be quite different from an uncontrolled study when intervention assignment is randomized and blinded, particularly if placebo is a distinct possibility.”
§ The Role and Interpretation of Pilot Studies in Clinical Research > WHAT A PILOT STUDY CAN DO: ASSESS FEASIBILITY > Rationale for a Control or Comparison Group in a Pilot
hedgedcorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: unclear — It is unclear whether it could be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“With these issues in mind, a pilot study can better address its goals if a control group is part of the design.”
§ The Role and Interpretation of Pilot Studies in Clinical Research > WHAT A PILOT STUDY CAN DO: ASSESS FEASIBILITY > Rationale for a Control or Comparison Group in a Pilot
plainconditional- Asserted: passes — The authors put it forward as true.
- Checkable: unclear — It is unclear whether it could be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“A case series estimate tends to be steeped in optimism, particularly if an estimate of such magnitude is seldom, if ever, seen in full scale trials for psychiatric disorders.”
§ The Role and Interpretation of Pilot Studies in Clinical Research > EXCEEDING THE LIMITATIONS OF A PILOT STUDY: WHAT PILOT STUDIES CANNOT DO > Pilot Study Effect Sizes and Sample Size Determination
hedgedcorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“(It is the population effect size, not the sample effect size, that an RCT is designed to detect with sufficient power.)”
§ The Role and Interpretation of Pilot Studies in Clinical Research > EXCEEDING THE LIMITATIONS OF A PILOT STUDY: WHAT PILOT STUDIES CANNOT DO > Pilot Study Effect Sizes and Sample Size Determination
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A claim is checked only against the cited paper’s full text, never its abstract, and none is available for its sources.
In the paper
“There has been a venerable tradition of using pilot studies to estimate between group effect sizes that, in turn, are used to inform the design of subsequent larger scale hypothesis testing studies. Despite it widespread use, it has been argued that the tradition is ill-founded. (Friedman, Furberg and DeMets, 1998; Kraemer et al., 2006)”
§ The Role and Interpretation of Pilot Studies in Clinical Research > EXCEEDING THE LIMITATIONS OF A PILOT STUDY: WHAT PILOT STUDIES CANNOT DO > Pilot Study Effect Sizes and Sample Size Determination
What the sources say
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“A pilot sample size is instead based on the pragmatics of recruitment and the necessities for examining feasibility.”
§ The Role and Interpretation of Pilot Studies in Clinical Research > SAMPLE SIZE DETERMINATION IN DESIGNING A PILOT STUDY
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“With no inferential statistical tests, a pilot study will not provide p-values.”
§ The Role and Interpretation of Pilot Studies in Clinical Research > SAMPLE SIZE DETERMINATION IN DESIGNING A PILOT STUDY
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Pilot study data generally should not be combined with data from the subsequent larger scale study. This is because it is quite likely that the methods will be modified after the pilot, even if minimally. Such changes in protocol risk adding additional, perhaps unknown, source of variation.”
§ The Role and Interpretation of Pilot Studies in Clinical Research > SAMPLE SIZE DETERMINATION IN DESIGNING A PILOT STUDY > Are Pilot Data Included in the Larger Trial?
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Rests on an assumption: Methods will likely be modified after a pilot study, even if minimally.
- It may state two separate claims as one. 13
- Probably not a substantial claim. 13
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Pilot results can inform feasibility and identify modifications needed in the design of a larger, ensuing hypothesis testing study.”
- Also stated in: § DISCUSSION · plain
“Pilot results inform feasibility, which in turn, is instructive in that it points to modifications needed in the planning and design of a larger efficacy trial.”
§ The Role and Interpretation of Pilot Studies in Clinical Research > Abstract
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Also stated in: § DISCUSSION · plain
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The definition of clinically meaningful is not entirely empirically-based, but instead requires input from clinicians who treat the patient population of interest and perhaps from patients with the disorder.”
§ The Role and Interpretation of Pilot Studies in Clinical Research > DISCUSSION
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: fails — It may be too vague to check against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: fails — The paper may give no reason why it holds.
Probably not a substantial claim. It may be too vague to check against evidence. The paper may give no reason why it holds.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“These good clinical practices include the refinement of source documentation, informed consent procedures, data collection tools, regulatory reporting procedures, and monitoring/oversight procedures, especially when multiple sites and investigators are engaged in the study.”
§ The Role and Interpretation of Pilot Studies in Clinical Research > WHAT A PILOT STUDY CAN DO: ASSESS FEASIBILITY > Good Clinical Practices
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: fails — The paper may give no reason why it holds.
Probably not a substantial claim. The paper may give no reason why it holds.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Safety, efficacy and effectiveness are not evaluated in a pilot.”
- Also stated in: § DISCUSSION · plain
“a pilot study is not a hypothesis testing study and therefore safety and efficacy are not evaluated.”
§ The Role and Interpretation of Pilot Studies in Clinical Research > Abstract
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Also stated in: § DISCUSSION · plain
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Pilot studies generate pilot data, their design need not be guided with the support of prior pilot data.”
§ The Role and Interpretation of Pilot Studies in Clinical Research > SAMPLE SIZE DETERMINATION IN DESIGNING A PILOT STUDY > Pilot Data for a Pilot Study
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: fails — The paper may give no reason why it holds.
Probably not a substantial claim. The paper may give no reason why it holds. It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“It is possible, but highly unlikely, that the between group effect size (d) from a pilot study sample will provide a reasonable estimate of the population effect size (Δ), but that cannot be known based on the pilot data.”
§ The Role and Interpretation of Pilot Studies in Clinical Research > EXCEEDING THE LIMITATIONS OF A PILOT STUDY: WHAT PILOT STUDIES CANNOT DO > Pilot Study Effect Sizes and Sample Size Determination
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“A pilot study can be critical in research staff training and provide experiences that strengthen and confirm competencies and skills required for the investigation to be conducted with accuracy and precision.”
§ The Role and Interpretation of Pilot Studies in Clinical Research > WHAT A PILOT STUDY CAN DO: ASSESS FEASIBILITY > Good Clinical Practices
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: fails — It may be too vague to check against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. It may be too vague to check against evidence. The paper’s conclusions may not depend on it.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“An alternative approach is to base sample size estimates for a full scale RCT on what is deemed a clinically meaningful effect.”
§ The Role and Interpretation of Pilot Studies in Clinical Research > EXCEEDING THE LIMITATIONS OF A PILOT STUDY: WHAT PILOT STUDIES CANNOT DO > An Alternative to Using Pilot Data for Sample Size Determination
plain- Asserted: passes — The authors put it forward as true.
- Checkable: fails — It may be too vague to check against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. It may be too vague to check against evidence.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“A pilot study provides opportunity to develop consistent practices to enhance data integrity and the protection of human subjects.”
§ The Role and Interpretation of Pilot Studies in Clinical Research > WHAT A PILOT STUDY CAN DO: ASSESS FEASIBILITY > Good Clinical Practices
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“We learn little if anything about the efficacy of an intervention with data from a small sample; yet, as discussed earlier, a great deal can be learned from a pilot study.”
§ The Role and Interpretation of Pilot Studies in Clinical Research > EXCEEDING THE LIMITATIONS OF A PILOT STUDY: WHAT PILOT STUDIES CANNOT DO > Hypothetical Example
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“This applies to effects sizes for any type of outcome, be it a severity rating, a response status, or survival status.”
§ The Role and Interpretation of Pilot Studies in Clinical Research > EXCEEDING THE LIMITATIONS OF A PILOT STUDY: WHAT PILOT STUDIES CANNOT DO > Pilot Study Effect Sizes and Sample Size Determination
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Hence, with imprecision comes a vast disparity in sample size estimates and, if sample size determination for a subsequent study is based on an imprecise estimate, there is an enormous risk of underpowered or overpowered design.”
§ The Role and Interpretation of Pilot Studies in Clinical Research > EXCEEDING THE LIMITATIONS OF A PILOT STUDY: WHAT PILOT STUDIES CANNOT DO > Hypothetical Example
boosteddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“In summary, pilot studies are a necessary first step in exploring novel interventions and novel applications of interventions – whether in a new patient population or with a novel delivery system (e.g., transdermal patch).”
§ The Role and Interpretation of Pilot Studies in Clinical Research > DISCUSSION
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: fails — It may be too vague to check against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: fails — The paper may give no reason why it holds.
Probably not a substantial claim. It may be too vague to check against evidence. The paper may give no reason why it holds.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Although a pilot study will undoubtedly incorporate relevant outcome measures and can serve a vital role in treatment development, it is not, and should not, be considered a preliminary test of the intervention hypothesis.”
§ The Role and Interpretation of Pilot Studies in Clinical Research > EXCEEDING THE LIMITATIONS OF A PILOT STUDY: WHAT PILOT STUDIES CANNOT DO
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“The primary role of a pilot study is to examine the feasibility of a research endeavor.”
- Also stated in: § INTRODUCTION · plain
“The fundamental purpose of conducting a pilot study is to examine the feasibility of an approach that is intended to ultimately be used in a larger scale study.”
§ The Role and Interpretation of Pilot Studies in Clinical Research > DISCUSSION
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
- Also stated in: § INTRODUCTION · plain
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“This does not preclude the need for a theoretical rationale for the intervention or the methodology being proposed for a pilot study.”
§ The Role and Interpretation of Pilot Studies in Clinical Research > SAMPLE SIZE DETERMINATION IN DESIGNING A PILOT STUDY > Pilot Data for a Pilot Study
plain- Asserted: passes — The authors put it forward as true.
- Checkable: fails — It may be too vague to check against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: fails — The paper may give no reason why it holds.
Probably not a substantial claim. It may be too vague to check against evidence. The paper’s conclusions may not depend on it. The paper may give no reason why it holds.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“If a pilot study effect size is unduly large (i.e., a false positive result), subsequent trials will be designed with an inadequate number of participants to provide the statistical power needed to detect clinically meaningful effects and that would lead to negative trials.”
§ The Role and Interpretation of Pilot Studies in Clinical Research > EXCEEDING THE LIMITATIONS OF A PILOT STUDY: WHAT PILOT STUDIES CANNOT DO > Pilot Study Effect Sizes and Sample Size Determination
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“However, pilot studies provide an opportunity to implement and examine the feasibility of the adverse event reporting system.”
§ The Role and Interpretation of Pilot Studies in Clinical Research > EXCEEDING THE LIMITATIONS OF A PILOT STUDY: WHAT PILOT STUDIES CANNOT DO > Tolerability and Preliminary Safety
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“It is quite reasonable and expected that a pilot study is proposed with no pilot or other preliminary data supporting the proposal and that its proposed sample size is based on pragmatics such as patient flow and budgetary constraints.”
§ The Role and Interpretation of Pilot Studies in Clinical Research > SAMPLE SIZE DETERMINATION IN DESIGNING A PILOT STUDY > Pilot Data for a Pilot Study
plain- Asserted: passes — The authors put it forward as true.
- Checkable: fails — It may be too vague to check against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: fails — The paper may give no reason why it holds.
Probably not a substantial claim. It may be too vague to check against evidence. The paper may give no reason why it holds. It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“A pilot study can be used to evaluate the feasibility of recruitment, randomization, retention, assessment procedures, new methods, and implementation of the novel intervention.”
- Also stated in: § INTRODUCTION · plain
“evaluate the feasibility of recruitment, randomization, retention, assessment procedures, new methods, and/or implementation of the novel intervention.”
- Also stated in: § WHAT A PILOT STUDY CAN DO: ASSESS FEASIBILITY · plain
“A pilot study can be used to evaluate the feasibility of recruitment, randomization, retention, assessment procedures, and implementation of the novel intervention and each of these can be quantified”
§ The Role and Interpretation of Pilot Studies in Clinical Research > Abstract
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Also stated in: § INTRODUCTION · plain
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“There are two fundamental reasons that hypothesis testing is not used in a pilot study: the limited state of knowledge about the methods or intervention in the patient population to be studied and the smaller proposed sample size.”
§ The Role and Interpretation of Pilot Studies in Clinical Research > EXCEEDING THE LIMITATIONS OF A PILOT STUDY: WHAT PILOT STUDIES CANNOT DO
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“As a consequence, pilot studies can reduce the proportion of failed trials and allow research funds to be spent on projects for which feasibility has been demonstrated and quantified.”
§ The Role and Interpretation of Pilot Studies in Clinical Research > DISCUSSION
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Well-conceived and implemented pilot studies will reduce the risk of several problems that are commonly faced in clinical trials. These include the inability to recruit the proposed sample size and a corresponding reduction in statistical power, excessive attrition due to intolerable procedures or interventions, and the need to modify a protocol midway through a trial.”
§ The Role and Interpretation of Pilot Studies in Clinical Research > DISCUSSION
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: unclear — It is unclear why the paper says it holds.
It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Estimates become more precise with larger sample sizes.”
§ The Role and Interpretation of Pilot Studies in Clinical Research > EXCEEDING THE LIMITATIONS OF A PILOT STUDY: WHAT PILOT STUDIES CANNOT DO > Pilot Study Effect Sizes and Sample Size Determination
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: fails — The paper may give no reason why it holds.
Probably not a substantial claim. The paper may give no reason why it holds.
The paper relies on this without support.
The true population effect size is unknown when a pilot study is designed.
“An essential challenge of therapeutic development is that the true population effect size is unknown at the time a pilot study is designed.”
The paper relies on this without support.
Methods will likely be modified after a pilot study, even if minimally.
“This is because it is quite likely that the methods will be modified after the pilot, even if minimally.”
The paper relies on this without support.
Pilot results presented to grant review committees tend to be selective, overly optimistic, and at times misrepresentational.
“Furthermore, pilot results that are presented to grant review committees tend to be selective, overly optimistic and, at times, misrepresentational.”
The paper relies on this without support.
Many pilot studies have far fewer than 18 participants per group.
“Many pilot studies have far fewer than 18 participants/group and therefore even greater imprecision.”
The paper relies on this without support.
It is not unusual for research grant applications and pilot study publications to convey optimism based on pilot data.
“Nevertheless, it is not unusual for research grant applications and pilot study publications to convey such optimism, particularly when based on pilot data.”
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The cited source doesn’t support the claim as written.
In the citing paper
“The planned sample size was 30 allowing for attrition. This study will inform the sample size for any future RCT (Leon et al., 2011).”
From A mixed methods pilot and feasibility open trial of internet-delivered cognitive behaviour therapy (iCanADAPT Advanced) for people with advanced cancer with depression and/or anxiety (2021) · cites this paper as Leon et al., 2011
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“This was a pilot study which like other pilot studies of MI did not have a power calculation. 31,32”
From A Pilot Randomized Controlled Trial to Assess the Impact of Motivational Interviewing on Initiating Behavioral Therapy for Migraine (2020) · cites this paper as [31]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Data analyses in the context of a pilot study are not hypothesis-driven but serve to provide information regarding feasibility and acceptability of the intervention [55].”
From Acceptance and Commitment Therapy Wellness Program for Latine Adults Who Smoke and Have Psychological Distress: Protocol for a Feasibility Study (2023) · cites this paper as [55]
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
In the citing paper
“A common misuse of pilot and feasibility studies has been the application of hypothesis testing for clinical outcomes in small under-powered studies.”
From Determining sample size for progression criteria for pragmatic pilot RCTs: the hypothesis test strikes back! (2021) · cites this paper as [20]
The cited source says what the claim attributes to it.
In the citing paper
“Hypothesis testing in pilot studies, particularly in the context of effectiveness/efficacy of clinical outcomes, has been widely criticised due to the improper purpose and lack of statistical power of such evaluations [2, 20, 21, 23].”
From Determining sample size for progression criteria for pragmatic pilot RCTs: the hypothesis test strikes back! (2021) · cites this paper as [20]
The cited source says what the claim attributes to it.
In the citing paper
“Since the focus was on feasibility and acceptability of the intervention and we did no hypothesis testing, no power calculation was required (Leon et al., 2011).”
From PandaMom – Feasibility and acceptability of an internet- and mobile-based intervention to enhance peripartum mental well-being and to prevent postpartum depression (2024) · cites this paper as Leon et al., 2011
The check wasn’t confident either way, so it gives no verdict — never disputed.
In the citing paper
“Our use of effect sizes was, however, deemed appropriate for this pilot trial (55, 63).”
From EMPOWER: A Multi-Site Pilot Trial to Reduce Distress in Surrogate Decision-Makers in the ICU (2024) · cites this paper as [63]
Experimental — accuracy not yet measuredIn the citing paper
“Previous work suggests early studies often test feasibility of methods (e.g., recruitment, randomization, retention, and assessment), not hypotheses [48].”
From Agile science: creating useful products for behavior change in the real world (2016) · cites this paper as [48]
In the citing paper
“In terms of statistics, a Bayesian approach might be more appropriate than Fisherian statistics [56] as the Fisher approach is not appropriate with limited data [48].”
From Agile science: creating useful products for behavior change in the real world (2016) · cites this paper as [48]
Citations
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. Caution regarding the use of pilot studies to guide power calculations for study proposals.
Kraemer, H. C., Mintz, J., Noda, A., Tinklenberg, J., & Yesavage, J. A. (2006) · Archives of General Psychiatry · doi:10.1001/archpsyc.63.5.484 · Cited by 702 · cited 1×
“(Friedman, Furberg and DeMets, 1998; Kraemer et al., 2006) Pilot study results should not be used for sample size determination due to the inherent imprecision in between treatment group effect size estimates from studies with small samples.”
Self-citationWolfstein (1905) · The Journal of Nervous and Mental Disease · doi:10.1097/00005053-190502000-00009 · Cited by 346
Attrition in randomized controlled clinical trials: methodological issues in psychopharmacology
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“(Leon et al., 2006; Leon & Davis, 2009).”
Self-citationSixteen S ‐squared over D ‐squared: A relation for crude sample size estimates
Lehr, R. (1992) · Statistics in Medicine · doi:10.1002/sim.4780110811 · Cited by 253 · cited 1×
“(N/group ≈ 16/d2; Lehr, 1992) The clinical interpretation of HAMD change of 1.2 to 3.0 would drive the choice among possible sample sizes in planning a study.”
BackgroundInfluentialJovanovic, B. D., & Levy, P. S. (1997) · The American Statistician · doi:10.1080/00031305.1997.10473947 · Cited by 179 · cited 1×
“…a particular category, the rule of three should be applied to estimate the upper bound of the 95% CI, where the upper bound is approximately 3/n. (Jovanovic & Levy, 1997; Jovanovic et al., 1997) For example, consider a study with N=15 receiving medication and no suicidal ideation was reported…”
BackgroundHarvey, I. M. (2009) · Public Health · doi:10.1016/j.puhe.2009.05.009 · Cited by 173
Jovanovic, B. D., & Levy, P. S. (1997) · The American Statistician · doi:10.2307/2685405 · Cited by 50
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Chu, K., Escobar-Viera, C. G., Matheny, S. J., Davis, E. M., & Primack, B. A. (2019) · Trials · doi:10.1186/s13063-019-3246-2 · Cited by 6
Jackson, H., López, C. M., Miller, S., & Englehardt, B. (2020) · Substance Abuse · doi:10.1080/08897077.2020.1784360 · Cited by 6
Approaches to cervical spine mobilization for neck pain: a pilot randomized controlled trial
Lagoutaris, C., Sullivan, J., Hancock, M., & Leaver, A. M. (2020) · Chiropractic & Manual Therapies · doi:10.1186/s12998-020-00348-z · Cited by 6
Evaluating a CTSA-funded pilot grant program
Morozumi, K., Patel, T., Kerr, P., et al. (2020) · Journal of Clinical and Translational Science · doi:10.1017/cts.2020.557 · Cited by 6
Merdian, H. L., Perkins, D. E., McCashin, D., & Stevanovic, J. (2020) · Psychology Crime and Law · doi:10.1080/1068316x.2020.1849690 · Cited by 7
“Feasibilitytesting of an intervention is a necessary step of piloting its suitability for randomised controlled trial (e.g. see Hendrix et al., 2009) and a fundamental part of, not an alternative to, randomised controlled research (Leon et al., 2011).”
BackgroundThe Healing Hearts at Home© Mobile Application Usability and Influence on Parental Perceived Stress
Miller, V. A., Newcombe, J. B., Radovich, P., Johnston, F., Medina, E., Jr., & Nelson, A. P. (2021) · International Journal of E-Health and Medical Communications · doi:10.4018/ijehmc.20210501.oa6 · Cited by 5
Sevelius, J. M., Neilands, T. B., Reback, C. J., Castro, D. A., Dilworth, S. E., Kaplan, R. L., & Johnson, M. O. (2021) · Frontiers in Reproductive Health · doi:10.3389/frph.2021.665723 · Cited by 7
“Research Ethics Approval This study was reviewed and approved by the University of California, San Francisco Institutional Review Board (15-17910) and the Western Institutional Review Board (20181370).”
BackgroundMethodInfluentialGPS for Success: A Practitioner-Based Study With High School Students
Spargo, A., Mullen, P. R., Gutiérrez, D., & Kramer, J. (2021) · Professional School Counseling · doi:10.1177/2156759x211050414 · Cited by 6
Cáceres, N. A., Yu, Q., Lauzon, M., Diniz, M. A., Tuckerman, R., Carrillo, A. A., Philipp, M. A., Foster, G. D., Seitz, A. R., & Salvy, S. (2022) · Obesity Science & Practice · doi:10.1002/osp4.617 · Cited by 6
“An a priori sample size calculation was not conducted due to the feasibility nature of this pilot study.(43,44) Descriptive statistics including frequencies, percentages, means and standard deviations were used to”
MethodHealth and wellness for disadvantaged older adults: The AFRESH pilot study
Maxwell, C. A., Roberts, C., Oesmann, K., Muhimpundu, S., Archer, K. R., Patel, M. R., Mogos, M. F., Muchira, J. M., Boon, J. T., & LaNoue, M. D. (2022) · PEC Innovation · doi:10.1016/j.pecinn.2022.100084 · Cited by 6
“Literature supports the use of pilot studies to determine feasibility and to find early signals of efficacy [90].”
Patient satisfaction with clinicians in colorectal 2-week wait clinics
Cock, K., & Kent, B. (2017) · British Journal of Nursing · doi:10.12968/bjon.2017.26.6.319 · Cited by 6
Feasibility of Music and Hypnotic Suggestion to Manage Chronic Pain
Johnson, A. J., Kekecs, Z., Roberts, R. L., Gavin, R. B., Brown, K. S., & Elkins, G. R. (2017) · International Journal of Clinical and Experimental Hypnosis · doi:10.1080/00207144.2017.1348858 · Cited by 7
Fleischer, T., Chang, T., Chiang, J., et al. (2018) · Integrative Cancer Therapies · doi:10.1177/1534735418756736 · Cited by 6
“Our goals have been to test the feasibility of the proposed protocol and to assess the compliance rate of patients and the adequacy of our inclusion and exclusion criteria, among other factors, with the intention of building on these insights to conduct a more comprehensive randomized trial.(28) Of the 7 patients who…”
MethodNewins, A. R., & White, S. W. (2018) · Journal of Interpersonal Violence · doi:10.1177/0886260518792974 · Cited by 6
“Before evaluating efficacy of an intervention program, it is important that the program is found to be both feasible to administer and acceptable to the target population (e.g., Leon et al., 2011).”
BackgroundInfluentialPharmacist-led academic detailing intervention in primary care: a mixed methods feasibility study
Riordan, D. O., Hurley, E., Sinnott, C., Galvin, R., Dalton, K., Kearney, P. M., Halpin, J., & Byrne, S. (2019) · International Journal of Clinical Pharmacy · doi:10.1007/s11096-019-00787-6 · Cited by 6
Stockton, D., Kellett, S., Wilkinson, N., Hague, J., Bliss, P., Heaver, M., & Devine, A. (2021) · International Journal of Cognitive Therapy · doi:10.1007/s41811-021-00118-6 · Cited by 5
Kelley, M. L., Bravo, A. J., Burgin, E. E., Gaylord, S. A., Vinci, C., Strowger, M., Gabelmann, J. M., & Currier, J. M. (2025) · Journal of Clinical Psychology · doi:10.1002/jclp.23778 · Cited by 5
“In MAT, Lindsay and Creswell (2019) contend that with time and practice, attention monitoring and acceptance skills may reduce negative affectivity, stress, and stress ‐ related health outcomes (Lindsay and Creswell 2019).”
InfluentialStress Response Analysis via Dynamic Entropy in EEG: Caregivers in View
Zavala-Yoé, R., Iqbal, H. M. N., Parra‐Saldívar, R., et al. (2023) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph20105913 · Cited by 5
Matejin, S., Gregorič, I. D., Radovancevic, R., Paessler, S., & Perović, V. (2024) · Frontiers in Microbiology · doi:10.3389/fmicb.2024.1422393 · Cited by 7
“There are many justifications for conducting studies with small sample sizes in medical research (Leon et al., 2011; Indrayan and Mishra, 2021).”
BackgroundSchafer, M., Lachman, J. M., Zinser, P., Calderón, F., Han, Q., Facciolà, C., Clements, L., Gardner, F. E. M., Ronnie, G. H., & Sheil, R. (2024) · JMIR Formative Research · doi:10.2196/58611 · Cited by 5
Bannerjee, S. S., Pillai, R., Tabash, M. I., & Al-Absy, M. S. M. (2025) · Economies · doi:10.3390/economies13030066 · Cited by 6
Non-Pharmacological Interventions Addressing Chronic Pain in People Living with HIV
Chen, Y., & Safren, S. A. (2025) · Current HIV/AIDS Reports · doi:10.1007/s11904-025-00734-3 · Cited by 5
Heffner, J. L., Baker, K., Georgiou, K., Graham, A. L., Kelly, M. M., Konstantinou, P., Lamprou, E., Lele, C., Lok, K. Z., Orzechowski, M., et al. (2025) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntaf112 · Cited by 5
“Given that pilot and feasibility trials are not appropriate designs for testing hypotheses regarding the efficacy of interventions, 24,29 we focused on descriptive differences as an alternative to hypothesis testing.”
Zoniou, A. K., Αντωνιάδου, Μ., & Saridou, S. (2025) · Applied Sciences · doi:10.3390/app15147987 · Cited by 10
Li, Q., Zhang, D., Quinn, É., Walsh, P. K., & Hynes, S. M. (2026) · International Journal of Nursing Studies Advances · doi:10.1016/j.ijnsa.2026.100490 · Cited by 5
“This could also contribute to the null results, as pilot studies are less capable of testing for statistical significance between groups due to their small populations, exploratory nature, and emphasis on feasibility and refinement (Leon et al., 2011).”
Greenberg, J., Singh, T., Popok, P., Kulich, R. J., & Vranceanu, A. (2021) · International Journal of Behavioral Medicine · doi:10.1007/s12529-021-09971-3 · Cited by 5
Chinsen, A., Cronin, T. J., Pace, C. C., Tollit, M. A., & Pang, K. C. (2024) · BMJ Open · doi:10.1136/bmjopen-2023-076511 · Cited by 5
“…trial and pilot RCT is to evaluate the feasibility and acceptability of the TAG TEAM programme and study design rather than to assess the efficacy of the intervention, sample size was chosen on the basis of feasibility and practicality, 39 and did not require a statistical power calculation.”
MethodEarnshaw, V. A., Sepucha, K., Laurenceau, J., Subramanian, S. V., Hill, E. C., Wallace, J., Brousseau, N. M., Henderson, C., Brohan, E., Morrison, L. M., et al. (2023) · Journal of Substance Use and Addiction Treatment · doi:10.1016/j.josat.2024.209291 · Cited by 5
Palfai, T. P., Morone, N. E., Kratzer, M. P. L., Murray, G. E., Otis, J. D., Maisto, S. A., & Rowland, B. H. P. (2024) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2024.111121 · Cited by 6
Bayrakdarian, N. D., Bonar, E. E., Duguid, I., Hellman, L., Salino, S., Wilkins, C., Jannausch, M. L., McKay, J. R., Staton, M., Dollard, K., et al. (2024) · Drug and Alcohol Dependence Reports · doi:10.1016/j.dadr.2024.100225 · Cited by 5
“Consistent with recommendations for pilot studies (Leon et al., 2011), caution should be used in the interpretation of clinical outcomes and candidate behavioral economic mechanisms.”
BackgroundMethodGuastaferro, K., Abuchaibe, V., McCormick, K. V., et al. (2024) · PLoS ONE · doi:10.1371/journal.pone.0302982 · Cited by 5
“Due to the study design and sample size, the results presented herein should not be interpreted as conclusive [38].”
BackgroundResultTalabi, M. B., Clowse, M. E. B., Abebe, K. Z., et al. (2025) · ACR Open Rheumatology · doi:10.1002/acr2.11791 · Cited by 5
Rahbar, M. H., Dickerson, A. S., Cai, C. C., Pedroza, C., Hessabi, M., Shen, L. F., Pandurengan, R. K., Jacobs, A., Indupuru, H. K. R., Sline, M. R., et al. (2015) · Contemporary Clinical Trials · doi:10.1016/j.cct.2015.08.007 · Cited by 5
“For many years single site randomized controlled clinical trials (RCTs) were designed and implemented to evaluate safety, efficacy, and/or effectiveness of various interventions, with a particular focus on health interventions [7–9].”
BackgroundMailhot, T., Cossette, S., Bourbonnais, A., et al. (2014) · Trials · doi:10.1186/1745-6215-15-306 · Cited by 5
“A convenience sample of 30 patient-caregiver dyads will be recruited based on the specific published literature on pilot studies [45-48].”
MethodMood and influenza vaccination in older adults: A randomized controlled trial.
Ayling, K., Fairclough, L. C., Buchanan, H., Wetherell, M. A., & Vedhara, K. (2019) · Health Psychology · doi:10.1037/hea0000786 · Cited by 5
Faculty Beliefs about the Nature of Intelligence
Rubin, L. M., Dringenberg, E., Lane, J., & Wefald, A. J. (2019) · Journal of the Scholarship of Teaching and Learning · doi:10.14434/josotl.v19i4.24158 · Cited by 9
“Leon, Davis, and Kraemer (2011) emphasized, “The primary role of a pilot study is to Journal of the Scholarship of Teaching and Learning, Vol. 19, No. 4, October 2019. josotl.indiana.edu examine the feasibility of a research endeavor” and is not meant to highlight statistical power or complex…”
BackgroundRanakusuma, R. W., McCullough, A. R., Safitri, E. D., Pitoyo, Y., Widyaningsih, W., Mar, C. D., & Beller, E. (2020) · Pilot and Feasibility Studies · doi:10.1186/s40814-020-00671-5 · Cited by 5
Swindle, T., Martinez, A., Børsheim, E., & Andres, A. (2020) · BMJ Open · doi:10.1136/bmjopen-2020-038582 · Cited by 6
Teaching shape bias to increase the expressive vocabularies of late talkers
Niese, H. L., & Brackenbury, T. (2020) · Clinical Archives of Communication Disorders · doi:10.21849/cacd.2020.00234 · Cited by 5
“As a pilot study, it is small in scale and designed to assess methodological efficiency and feasibility in order to guide and support future investigations [43-45].”
BackgroundBonete, S., Osuna, Á., Molinero, C., & García-Font, I. (2021) · Frontiers in Psychology · doi:10.3389/fpsyg.2021.649527 · Cited by 5
Varenicline for the Treatment of Cocaine Dependence
Lynch, K. G., Plebani, J. G., Spratt, K. A., Morales, M., Tamminga, M. A., Feibush, P., & Kampman, K. M. (2021) · Journal of Addiction Medicine · doi:10.1097/adm.0000000000000842 · Cited by 5
“Pilot trials frequently result in both false positive and false-negative results.(39) Varenicline was well tolerated in this trial and there was relatively little missing data.”
BackgroundBaptist, A. P., Gibson-Scipio, W. M., Carcone, A. I., Ghosh, S., Jacques‐Tiura, A. J., Hall, A. L., & MacDonell, K. K. (2022) · JMIR Research Protocols · doi:10.2196/37946 · Cited by 4
Agley, J. D., Barnes, P. A., Tidd, D., Todd, A., Friedman, K., Gordon, S., Richardson, J., & Delong, J. (2022) · INQUIRY The Journal of Health Care Organization Provision and Financing · doi:10.1177/00469580221097428 · Cited by 5
Educational Breakout and Sustainable CLIL Teacher Training
Polyakova, O., & Cócera, L. D. R. (2022) · Psychological Science and Education · doi:10.17759/pse.2022270208 · Cited by 5
“They are widely utilised in clinical research and social sciences [17; 32].”
BackgroundA Randomized, Controlled Pilot Study of Mindfulness-Based Stress Reduction in Healthy Older Adults
Lwi, S. J., Paulraj, S. R., Schendel, K. L., Dempsey, D. G., Curran, B. C., Herron, T. J., & Baldo, J. V. (2022) · Clinical Gerontologist · doi:10.1080/07317115.2022.2137075 · Cited by 9
Indoor environmental factors affecting the productivity of workers in office buildings
Liu, F., Chang-Richards, A. Y., Wang, K. I., & Dirks, K. N. (2022) · IOP Conference Series Earth and Environmental Science · doi:10.1088/1755-1315/1101/2/022001 · Cited by 8
Occupation as means and ends in paediatric occupational therapy – A systematic review
Fischer, E., Green, D., & Lygnegård, F. (2023) · Scandinavian Journal of Occupational Therapy · doi:10.1080/11038128.2023.2188253 · Cited by 5
“…cohort studies, single-subject designs, case series, case reports, expert opinion), systematic reviews, pilot/preliminary and feasibility studies [110]; Second publications of the same study – here the publication providing the most data relevant to this review will be used and other…”
BackgroundIntervention for marijuana using, court-involved non-incarcerated youth
Kemp, K. A., Micalizzi, L., Becker, S. J., Cheaito, A., Suazo, N., Fox, K. A., Hernández, L., & Spirito, A. (2023) · Journal of Substance Use and Addiction Treatment · doi:10.1016/j.josat.2023.209100 · Cited by 6
O’Rourke, H. M., Swindle, J., Chacinski, D., Pizzol, F. L. F. D., Lee, H., Hoben, M., Hopper, T. L., McGilton, K. S., & Boscart, V. (2023) · Dementia · doi:10.1177/14713012231176858 · Cited by 5
Mindful practice with medical interpreters
Roman, G., Nooraie, R. Y., Vermilion, P., Cupertino, A. P., Barnett, S. L., & Epstein, R. M. (2023) · Frontiers in Psychology · doi:10.3389/fpsyg.2023.1171993 · Cited by 6
Clinical research on extreme longevity: The FACET experience
Azzolino, D., Rodrigues, G. D., Manzini, V. M., Proietti, M., Arosio, B., Montano, N., & Cesari, M. (2023) · Ageing Research Reviews · doi:10.1016/j.arr.2023.102170 · Cited by 5
Effects of MBCT training on anxiety-related personality traits in medical students: a pilot study
Yin, D., Wang, H., Xu, X., Jin, C., Wang, Z., & Wang, T. (2023) · Current Psychology · doi:10.1007/s12144-023-05300-x · Cited by 4
“Instead, it was determined based on the pragmatics of recruitment and the necessities for examining feasibility (Leon et al., 2011).”
Martland, R., Valmaggia, L., Paleri, V., Steer, N., & Riches, S. (2024) · Mental Health and Digital Technologies · doi:10.1108/mhdt-11-2023-0001 · Cited by 5
Bonar, E. E., Tan, C. Y., Fernandez, A. C., Goldstick, J. E., Chapman, L., Florimbio, A. R., & Walton, M. A. (2024) · Alcohol and Alcoholism · doi:10.1093/alcalc/agae005 · Cited by 6
Eldesouky, L., & Gross, J. J. (2024) · European Journal of Oncology Nursing · doi:10.1016/j.ejon.2024.102578 · Cited by 8
Snowdon, D. A., Vincent, P., Callisaya, M. L., Collyer, T. A., Brusco, N. K., Wang, Y. T., & Taylor, N. F. (2024) · Physiotherapy · doi:10.1016/j.physio.2024.05.002 · Cited by 6
Development of a mindfulness-based intervention for narcolepsy: a feasibility study
Mundt, J. M., Zee, P. C., Schuiling, M. D., Hakenjos, A. J., Victorson, D. E., Fox, R. S., Dawson, S. C., Rogers, A. E., & Ong, J. C. (2024) · SLEEP · doi:10.1093/sleep/zsae137 · Cited by 7
O’Connor, C. M. C., Poulos, R. G., Heldon, M., Preti, C., Beattie, E., & Poulos, C. J. (2024) · Journal of Geriatric Psychiatry and Neurology · doi:10.1177/08919887241267335 · Cited by 5
“While the outcomes presented are representative of these study participants only, 77 the fi ndings provide important insights into areas for further investigation.”
Berlowitz, I., Torres, E. G., Macedo, J. C. R., Wolf, U., Maake, C., & Martin-Söelch, C. (2024) · Health Education & Behavior · doi:10.1177/10901981231213348 · Cited by 7
“Given the “novelty” of the treatment from a scientific perspective, we used a pilot study approach with a naturalistic/ observational field design (Leon et al., 2011).”
Latimer, S. L., Chaboyer, W. P., Walker, R., Thalib, L., Deakin, J. L., & Gillespie, B. M. (2024) · Australian Critical Care · doi:10.1016/j.aucc.2024.101133 · Cited by 5
Mace, R. A., Law, M. E., Cohen, J. E., Ritchie, C. S., Okereke, O. I., Hoeppner, B. B., Brewer, J. A., Bartels, S. J., Vranceanu, A., & My Healthy Brain Team (2024) · JMIR Research Protocols · doi:10.2196/64149 · Cited by 6
“Consistent with NIH stage 1B [62] and pilot study guidelines [76,77], our primary outcomes are a priori markers for feasibility, acceptability, appropriateness, credibility, satisfaction, and fidelity.”
Wang, C., Zhu, C., & Zuo, B. (2025) · The Journal of General Psychology · doi:10.1080/00221309.2025.2478002 · Cited by 5
“According to a previous study (Leon et al., 2011; Whitehead et al., 2016), power analyses in pre-study are used to determine the sample size that is needed to provide statistical power of 80%, and a valid sample size of more than 50 per group was appropriate.”
WellnessRx Education Initiative
Bistritz, L., Kovacs-Burns, K., Avdagovska, M., McCargar, L. J., Olson, K. L., & Gramlich, L. M. (2015) · Pedagogy in Health Promotion · doi:10.1177/2373379914559217 · Cited by 5
Pereira, M., Dyregrov, K., Hauken, M. A., Senneseth, M., & Dyregrov, A. (2016) · JMIR Research Protocols · doi:10.2196/resprot.5765 · Cited by 5
“Rather than focusing on hypothesis testing, this pilot study builds on the practical limitations of recruitment and topics of incertitude, such as the need to gather initial estimations for sample size calculation [57,59,60].”
Objective Evaluation of Performance Stress in Musicians With Focal Hand Dystonia: A Case Series
Ioannou, C. I., Furuya, S., & ALTENMÜLLER, E. O. (2016) · Journal of Motor Behavior · doi:10.1080/00222895.2016.1161590 · Cited by 5
“Pilot studies do not always provide useful information with respect to effect size, which can be affected by false positive or false negative results (Leon et al., 2011).”
BackgroundLowthian, J. A., Lennox, A., Curtis, A. J., Dale, J. R., Browning, C. J., Smit, D. V., Wilson, G., O’Brien, D., Rosewarne, C., Boyd, L., et al. (2016) · BMJ Open · doi:10.1136/bmjopen-2016-013179 · Cited by 6
“recruitment and the necessities for examining feasibility.(46)”
Project reach: Piloting a risk-tailored smoking cessation intervention for lung screening
Lennes, I. T., Luberto, C. M., Carr, A. L., Hall, D. L., Strauss, N. M., Ponzani, C. J., & Park, E. R. (2018) · Journal of Health Psychology · doi:10.1177/1359105318756500 · Cited by 5
“We used a single-arm trial design, given our primary aims to establish feasibility and acceptability (Kistin and Silverstein, 2015; Leon et al., 2011).”
MethodMota, J. F., Rezio, M. A., Soares, R. C., Pimentel, G. D., Coelho, A. S. G., & Cunha, J. (2018) · BioMed Research International · doi:10.1155/2018/8485103 · Cited by 5
“The researchers were previously trained to standardize the collection procedure, minimize possible errors, and guarantee the quality of the data collected [8].”
BackgroundUse of the Kawa Model to Facilitate Interprofessional Collaboration: A Pilot Study
Lape, J. E., Lukose, A., Ritter, D., et al. (2019) · Internet Journal of Allied Health Sciences and Practice · doi:10.46743/1540-580x/2019.1780 · Cited by 5
Lanesman, T. H., & Schrieff, L. E. (2020) · Neuropsychological Rehabilitation · doi:10.1080/09602011.2020.1782233 · Cited by 5
“Leon et al. (2011) recommend that pilot studies should explore factors such as recruitment, randomization, assessment procedures, retention of participants, treatment adherence, and implementation of a novel intervention.”
BackgroundCharacteristics of piloting longitudinal birth cohort surveys: a systematic review
Blažev, M., Babarović, T., & Serracant, P. (2020) · Quality & Quantity · doi:10.1007/s11135-020-01042-1 · Cited by 5
Foot Care Self-Management in Non-Diabetic Older Adults: A Pilot Controlled Trial
O’Connor, J. J., Deroche, C. B., & Wipke‐Tevis, D. D. (2020) · Western Journal of Nursing Research · doi:10.1177/0193945920962712 · Cited by 5
“…to eight when teaching psychomotor skills (Snider et al., 2012) and pilot study sample sizes can be based on participant and budget availability (Leon et al., 2011), the desired sample size was 32 with the Intervention group (n=16) being divided into two class sections of eight participants…”
BackgroundDunlop, S. M., Kimonis, E. R., & Agazzi, H. C. (2020) · Evidence-Based Practice in Child and Adolescent Mental Health · doi:10.1080/23794925.2020.1796552 · Cited by 5
“In accordance with recommendations for small sample sizes (Leon et al., 2011; Thabane et al., 2010), confidence intervals are presented and Cohen’s d effect sizes were calculated and interpreted according to Cohen (1988) where d = 0.8 is large, d = 0.5 is medium and d = 0.2 is small.”
MethodInfluentialGreenberg, J., Singh, T., Popok, P., Kulich, R. J., & Vranceanu, A. (2021) · The Journal of Alternative and Complementary Medicine · doi:10.1089/acm.2020.0499 · Cited by 5
Distinctive aspects of consent in pilot and feasibility studies
Sim, J. (2021) · Journal of Evaluation in Clinical Practice · doi:10.1111/jep.13556 · Cited by 10
“participants, the consent rate, loss to follow-up, treatment fidelity, and compliance, and by testing methods of randomization, blinding and outcome measurement.(4,5) PFSs may additionally serve to inform a sample size calculation,(6) refine or fine-tune the interventions to be tested in a main trial,(2) and assess th…”
BackgroundZiebart, C., MacDermid, J. C., Bryant, D., et al. (2021) · BMJ Open · doi:10.1136/bmjopen-2020-046122 · Cited by 5
Santiago, R. J., Esteves, J. E., Baptista, J. S., Magalhães, A., & Costa, J. T. (2021) · Complementary Therapies in Clinical Practice · doi:10.1016/j.ctcp.2021.101507 · Cited by 5
Acupuncture for amnestic mild cognitive impairment
Zhang, J., Kuang, X., Tang, C., et al. (2021) · Medicine · doi:10.1097/md.0000000000027686 · Cited by 5
“Finally, we have set a control group to realistically examine recruitment, randomly allocation, complement of interventions, and blinding evaluation.([48]) Nowadays, placebo contrast for acupuncture contains non-acupoint, superficial, and sham acupuncture.”
MethodBeynon, C., Supiano, K. P., Siegel, E. O., Edelman, L. S., Hart, S., & Madden, C. (2022) · Research in Gerontological Nursing · doi:10.3928/19404921-20211209-05 · Cited by 5
Moreno, J. P., Dadabhoy, H., Musaad, S. M. A., Baranowski, T., Thompson, D. I., Alfano, C. A., & Crowley, S. J. (2022) · JMIR Research Protocols · doi:10.2196/37002 · Cited by 5
Keogh, S. J., Dhanani, J., Levido, A., Gracie, C., Ilushin, V., Palmer, J., Doubrovsky, A., Parker, S. L., Pintara, A. P., Huygens, F., et al. (2022) · Intensive and Critical Care Nursing · doi:10.1016/j.iccn.2022.103364 · Cited by 5
Joseph, A., Wallman, M., Scott, E., Ilchef, R., Harris, N., Jackson, A., & Bryant, R. A. (2023) · Injury · doi:10.1016/j.injury.2023.01.003 · Cited by 6
The Healthy Adult in Schema Therapy: Using the Octopus Metaphor
Salicru, S. (2023) · Psychology · doi:10.4236/psych.2023.146050 · Cited by 8
Hopkins, E. E., Wallace, M., Conley, Y., & Marazita, M. (2014) · Biological Research for Nursing · doi:10.1177/1099800414552186 · Cited by 6
Rüütel, E., Vinkel, I., & Laanetu, M. (2018) · Universal Journal of Public Health · doi:10.13189/ujph.2018.060502 · Cited by 5
Thomson, A., Young, K. M., Lygo‐Baker, S., Lothamer, C. W., & Snyder, C. J. (2019) · Journal of Veterinary Medical Education · doi:10.3138/jvme.0717-096r1 · Cited by 6
A framework toward successful business incubator for Indonesian Public Universities: A pilot review
Gozali, L., Masrom, M. B., Haron, H. N., Zagloel, T. Y. M., & Tjahjadi, E. (2018) · Cited by 5
Timko, C. A., Fitzpatrick, K. K., Goulazian, T., et al. (2020) · Journal of Clinical Psychology in Medical Settings · doi:10.1007/s10880-020-09704-w · Cited by 5
Moore, J. B., Dilley, J. R., Singletary, C. R., Skelton, J. A., MILLER, D. P., Heboyan, V., Leo, G. D., Turner‐McGrievy, G. M., McGrievy, M. J., & Ip, E. H. (2020) · JMIR Research Protocols · doi:10.2196/18098 · Cited by 5
“Feasibility is assessed consistent with the recommendations of Leon et al [33].”
MethodKinnear, F. J., Hamilton-Shield, J. P., Stensel, D. J., Bayly, G. R., Searle, A., Thackray, A. E., & Lithander, F. E. (2020) · Pilot and Feasibility Studies · doi:10.1186/s40814-020-00584-3 · Cited by 6
“This is an exploratory feasibility study and therefore no power calculation has been used to determine sample size because it is not designed or powered to address the effectiveness of the intervention being evaluated [25, 27, 28].”
MethodSun Safe Partners Online: Pilot Randomized Controlled Clinical Trial
Manne, S. L., Buller, D. B., Devine, K. A., Heckman, C. J., Pagoto, S., Frederick, S., & Mitarotondo, A. (2020) · Journal of Medical Internet Research · doi:10.2196/18037 · Cited by 5
“However, a fully powered randomized trial is needed to provide inferential tests on the effectiveness of Sun Safe Partners Online [36,37].”
BackgroundResultKnudsen, K. S., Becker, K. D., Guan, K., Gellatly, R., Patel, V., Malik, K., Boustani, M. M., Mathur, S., & Chorpita, B. F. (2021) · Journal of Evaluation in Clinical Practice · doi:10.1111/jep.13623 · Cited by 5
Autism spectrum disorder clinical trials: One step at a time
Lecavalier, L. (2016) · Autism · doi:10.1177/1362361315623111 · Cited by 5
“Small samples speak more to feasibility of recruitment, randomization, and retention than effect size (Leon et al., 2012).”
BackgroundNeal, J. L., Lowe, N. K., Nacht, A. S., et al. (2016) · Journal of Midwifery & Women s Health · doi:10.1111/jmwh.12442 · Cited by 5
Open Trial of Integrated Primary Care Consultation for Medically Unexplained Symptoms
Hubley, S. H., Uebelacker, L. A., Nash, J. M., & Eaton, C. B. (2016) · The Journal of Behavioral Health Services & Research · doi:10.1007/s11414-016-9528-5 · Cited by 5
HOW TELECOMMUTERS BALANCE WORK AND THEIR PERSONAL LIVES
Miller, T. (2016) · ProQuest Demo Repository · doi:10.13140/rg.2.2.27975.50083 · Cited by 5
Cogan, P. S. (2020) · Journal of Dietary Supplements · doi:10.1080/19390211.2020.1769246 · Cited by 5
Saeidnia, H. R., Kozak, M., Ausloos, M., et al. (2023) · Research Square · doi:10.21203/rs.3.rs-2872449/v1 · Cited by 5
Thompson, D., Cachelin, F., Striegel‐Moore, R. H., Barton, B., Shea, M., & Wilson, G. T. (2012) · International Journal of Eating Disorders · doi:10.1002/eat.22009 · Cited by 4
Metadata
- Authors
- Leon, A. C., Davis, L. L., & Kraemer, H. C.
- Affiliations
- Weill Cornell Medicine (US)
- University of Alabama (US)
- Stanford University (US)
- Corresponding author
- Leon, Andrew C.
- Venue
- Journal of Psychiatric Research
- Publisher
- Elsevier BV
- Published
- 2011-05
- Volume
- 45
- Issue
- 5
- Pages
- 626-629
- ISSN
- 0022-3956 (ISSN-L)
- PMC
- PMC3081994
- OpenAlex
- W2168434488
- Cited by
- 1,917
- References
- 17
- Citations by year
- 2026: 203 · 2025: 190 · 2024: 143 · 2023: 169 · 2022: 163 · 2021: 217 · 2020: 169 · 2019: 136 · 2018: 128 · 2017: 120 · 2016: 92 · 2015: 80 · 2014: 52 · 2013: 31 · 2012: 17
- FWCI
- 14.45
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Psychiatric Research (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institute of Mental Health (P30MH068638, R01MH060447)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Keywords
- pilot study, feasibility assessment, clinical trials, research design, sample size determination, effect size estimation, generalizability, recruitment and retention, intervention implementation, research funding review
- MeSH terms
- Clinical Trials as Topic, Data Interpretation, Statistical, Feasibility Studies, Humans, Pilot Projects, Biomedical Research
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