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
Cites
Fundamentals of Clinical Trials
Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015) · doi:10.1007/978-3-319-18539-2 · Cited by 2,237
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Friedman, L. M., Furberg, C. D., & DeMets, D. L. (1998) · doi:10.1007/978-1-4757-2915-3 · Cited by 873
. 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
Leon, A. C., Mallinckrodt, C. H., Chuang-Stein, C., Archibald, D. G., Archer, G. E., & Chartier, K. (2006) · Biological Psychiatry · doi:10.1016/j.biopsych.2005.10.020 · Cited by 303 · cited 1×
“(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
Cited by
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Items 1,101–1,200 of 1,903
Latimer, S. L., Walker, R., Hewitt, J. E., et al. (2025) · BMC Palliative Care · doi:10.1186/s12904-025-01853-9 · Cited by 3
“For feasibility studies, a sample size of between 10 and 50 participants is considered sufficient [24]; therefore we aimed to recruit a consecutive sample of 30 dying adult hospital patients meeting the study criteria, or 10 participants per hospital site.”
InfluentialGoetz, T. G., Kishton, R. E., & Wolk, C. B. (2025) · Journal of Primary Care & Community Health · doi:10.1177/21501319251357728 · Cited by 3
“Consistent with recommendations for pilot studies, 26 our primary goal was to examine the feasibility of the IGAP clinical model.”
Liu, Q., & Li, Y. (2025) · Sustainability · doi:10.3390/su17188478 · Cited by 3
Li, X., Safer, D. L., Paz, I. C., Menorca, R., & Girod, S. C. (2017) · Journal of Oral and Maxillofacial Surgery · doi:10.1016/j.joms.2017.11.025 · Cited by 3
Mallick, R. B., Thabane, L., Borhan, S., & Kathard, H. (2018) · South African Journal of Communication Disorders · doi:10.4102/sajcd.v65i1.583 · Cited by 3
“za Open Access (determining the treatment effect) (Evans, 2003; Leon et al., 2011; Oakley et al., 2006; Shanyinde et al., 2011).”
BackgroundAcupuncture in living liver and kidney donors: a feasibility study
Jesse, M. T., Kulas, M., Unitis, J., Beltran, N., & Abouljoud, M. S. (2018) · Journal of Chinese Integrative Medicine · doi:10.1016/j.joim.2018.11.007 · Cited by 3
Lucchini‐Raies, C., Doren, F. M., Beca, P., Pérez, J. C., Campos, S., & López‐Dicastillo, O. (2020) · Journal of Advanced Nursing · doi:10.1111/jan.14534 · Cited by 5
Mendoza, K. G., Aguila, M. E. R., Alfonso, F. C. S., Alfonso, M. G. T., Elmi, K. D., & Gorgon, E. J. R. (2020) · Acta Medica Philippina · doi:10.47895/amp.vi0.2434 · Cited by 3
Carrasco, A. S., Moessner, M., Carbonell, C. G., Rodríguez, C., Martini, N., Pérez, J. C., Garrido, P., Özer, F., Krause, M., & Bauer, S. (2020) · CES Psicología · doi:10.21615/cesp.13.3.14 · Cited by 3
Saldivar, P., Mira, V., Duran, P. A., Moldovan, C. P., Ang, G., Parikh, N., Lee, M. L., & Friedman, T. C. (2021) · Obesity Science & Practice · doi:10.1002/osp4.513 · Cited by 3
“Following the suggestion from Leon et al. 29 if we select a clinically meaningful effect of 3 pounds between text messaging intervention and group visit alone and assuming a standard deviation of 9 pounds then with 186 subjects in the group visit only arm and 185 individuals in the group visit plus text messaging arm,…”
MethodInfluentialFactors of Purchase Intention Toward Social Commerce Among Young Generation in Malaysia
En, A., Govindarajo, N. S., & Dileep, M. (2021) · International Conference on Law, Social Science, Economics, and Education (ICLSSEE) · doi:10.4108/eai.6-3-2021.2306398 · Cited by 5
Martland, R., Onwumere, J., Stubbs, B., & Gaughran, F. (2021) · Pilot and Feasibility Studies · doi:10.1186/s40814-021-00937-6 · Cited by 3
“This number is based on recruiting a big-enough sample to assess the feasibility of the study and on the resources available [52].”
BackgroundVeterans’ Insights on Heart Rate Variability Biofeedback to Treat Fibromyalgia-Related Pain
Reneau, M. G., & Nichols, M. G. (2021) · Pain Management Nursing · doi:10.1016/j.pmn.2021.06.003 · Cited by 3
Suhrheinrich, J., Wang, T., Chan, J., Holt, T., Stahmer, A. C., Rieth, S. R., Roesch, S. C., & Sam, A. M. (2021) · International Journal of Educational Research Open · doi:10.1016/j.ijedro.2021.100107 · Cited by 5
Vaughan, E., Ftanou, M., Lewin, J. H., Murnane, A., Berger, I., Wiley, J. F., Hickey, M., Bullen, D., Jefford, M., Goldin, J., et al. (2022) · Pilot and Feasibility Studies · doi:10.1186/s40814-022-01128-7 · Cited by 4
Newcombe, B. C., Olthuis, J. V., MacLean, M., Hamilton, R. A., & McAulay, T. (2023) · Journal of College Student Mental Health · doi:10.1080/87568225.2023.2181255 · Cited by 3
“Although hypothesis testing is not the purpose of a pilot study (Leon, Davis, & Kraemer, 2011), an examination of mean symptom scores indicated that anxiety, depression, and stress symptoms decreased to a greater degree for individuals in the CBT+E vs. TAU group.”
Kanmodi, K. K., Amoo, B. A., Nwafor, J. N., Nnyanzi, L. A., Ogbeide, M. E., Hundeji, A. A., & Adetunji, C. O. (2023) · Journal of Health and Allied Sciences NU · doi:10.1055/s-0042-1760439 · Cited by 4
Kiburi, S. K., Kwobah, E., Paruk, S., & Chiliza, B. (2023) · BMC Digital Health · doi:10.1186/s44247-023-00014-3 · Cited by 5
Shillingsburg, M. A., Bartlett, B. L., Thompson, T. M., McCracken, C., & Scahill, L. D. (2023) · Journal of Developmental and Physical Disabilities · doi:10.1007/s10882-023-09913-9 · Cited by 3
“In terms of efficacy in the current study, it is important to note that pilot, feasibility studies are not designed to test for treatment effects (Leon et al., 2011).”
Using a Cascading Approach to Improve Multisite Study Procedures
LaFond, C. M., Hanrahan, K., Bohr, N. L., et al. (2023) · Nursing Research · doi:10.1097/nnr.0000000000000665 · Cited by 3
“For a descriptive study, pilot studies can be used to determine the feasibility of procedures such as recruitment of the target population and develop tools and procedures, including those that enhance data integrity (Leon et al., 2011; NCCIH, n.d.).”
Siller, M., Morgan, L., Fuhrmeister, S., et al. (2023) · Autism · doi:10.1177/13623613231179289 · Cited by 3
“Given the current study’s focus on feasibility, the sample size was chosen based on the availability of resources and study constraints, and we prioritized maximizing sampling variability (e.g. providers, educators, parents) over the inclusion of a control group (Leon et al., 2011).”
BackgroundOsuna, A., Tagavi, D. M., Sabini, K., & Vernon, T. W. (2023) · Advances in Autism · doi:10.1108/aia-12-2022-0057 · Cited by 3
Guastaferro, K., Melchior, M., Murphy-Costanzo, A. S., Sunshine, S., Neimeyer, A., Stewart, S., & Noll, J. G. (2023) · Journal of Public Health Research · doi:10.1177/22799036231208329 · Cited by 3
RetractedThulasy, T. N., Nohuddin, P. N. E., & Nusyirwan, I. F. (2023) · The European Proceedings of Social & Behavioural Sciences · doi:10.15405/epsbs.2023.11.02.17 · Cited by 3
Sulaiman, S., Hamid, N. A., Othman, R. D., et al. (2024) · Journal of Asian Scientific Research · doi:10.55493/5003.v14i1.4980 · Cited by 3
Contribution of the Pilot Study for Methodological Enrichment of the Main Study
Shrestha, T., Bhandari, N., & Siluwal, N. (2024) · Journal of Health and Allied Sciences · doi:10.37107/jhas398 · Cited by 3
“Consistent with study findings, the previous study also reported the modification of the instruments and research design after PS. 5 Another study re-ported revision of the process and focus of the main study based on PS experience.”
InfluentialLiang, W., Chow, K. M., Ni, X., Tola, Y. O., & Lo, S. H. S. (2024) · Primary care diabetes · doi:10.1016/j.pcd.2024.09.010 · Cited by 3
Sánchez‐Ferrer, S., Antón, A. A., Miguel-Álvaro, A., & Crespo, M. (2024) · Counselling and Psychotherapy Research · doi:10.1002/capr.12843 · Cited by 3
Feasibility and acceptability of the TEAM pilot trial with African American and Latino families
Butler, A. M., Hilliard, M. E., Christopher, K., Baudino, M. N., Minard, C. G., & Karaviti, L. P. (2025) · Journal of Pediatric Psychology · doi:10.1093/jpepsy/jsaf001 · Cited by 3
Mutale, W., Graybill, L. A., Saidi, F., et al. (2025) · PLoS ONE · doi:10.1371/journal.pone.0319735 · Cited by 3
“[28] We used this pilot study to evaluate the feasibility of recruitment, randomization, retention, assessment procedures, of the iNSC intervention among pregnant and breastfeeding women living with HIV in Malawi.”
Barrett, A. J., Ke, F., Zhang, N., & Sokolikj, Z. (2025) · Computers & Education X Reality · doi:10.1016/j.cexr.2025.100106 · Cited by 3
Pischel, M., Wüster, A.-L., Metz, K., Wulf, H., Lahmann, C., & Pfeifer, E. (2025) · Counselling and Psychotherapy Research · doi:10.1002/capr.70035 · Cited by 2
Routledge, F. S., Davis, T. D., & Dunbar, S. B. (2016) · The Journal of Cardiovascular Nursing · doi:10.1097/jcn.0000000000000370 · Cited by 3
Ruslan, R., Baba, I., & Leman, A. M. (2017) · MATEC Web of Conferences · doi:10.1051/matecconf/20179701087 · Cited by 3
Lee, H.-Y., Kim, J.-E., Kim, A., Kim, A.-R., Park, H., Kwon, O., Cho, J.-H., Chung, S.-Y., & Kim, J. (2018) · Trials · doi:10.1186/s13063-017-2399-0 · Cited by 3
“This is a pilot study that aims to evaluate the feasibility of acupuncture treatment for HB and to confirm basic information about its effects and safety [46].”
BackgroundCollom, J., Davidson, J. R. T., Sweet, D., Gillard, S., Pinfold, V., & Henderson, C. (2019) · BMJ Open · doi:10.1136/bmjopen-2018-023768 · Cited by 3
“The target sample size of 24 is based on the pragmatics of testing the feasibility of delivering this intervention to inform a larger scale study; therefore, this sample size is appropriate.(36)”
MethodFigueiredo, S. M., & Mayo, N. E. (2015) · Disability and Rehabilitation · doi:10.3109/09638288.2015.1043471 · Cited by 3
“A pilot study is not a hypothesis testing study [5]; however, it is always beneficial to have a control group (even if there is no intent to do a between group comparison) as ‘‘nothing improves the appearance of an intervention so much as the absence of a control group’’ [6].”
BackgroundA novel cognitive cueing approach to gait retraining in Parkinson’s disease: A pilot study
Morrison, S. M., Spaulding, S. J., Holmes, J., & Jenkins, M. E. (2015) · The Open Journal of Occupational Therapy · doi:10.15453/2168-6408.1156 · Cited by 3
Cognitive therapy for patients with schizophrenia
Coyne, J. C., & van Linschoten, H. S. (2014) · The Lancet · doi:10.1016/s0140-6736(14)61273-3 · Cited by 3
The Effects of Dr. Oz on Health Behaviors and Attitudes
Crouch, E. L., Dickes, L., Davis, A., et al. (2016) · American Journal of Health Education · doi:10.1080/19325037.2016.1219283 · Cited by 3
“Exploratory studies are a necessary first step to explore the effects of interventions; however, nonsignificant results may very well be significant in a larger, later study.(25) Furthermore, the fact that Dr.”
ResultCluxton‐Keller, F., Donnelly, C. L., Williams, M., Buteau, J., Stolte, P., Monroe-Cassel, M., & BRUCE, M. L. (2017) · Pilot and Feasibility Studies · doi:10.1186/s40814-017-0203-2 · Cited by 4
“Pilot studies are used to assess the feasibility of an intervention for a larger scale study, and the use of pilot study effect size for sample size estimation can lead to type I and II errors [54].”
MethodHikayat Sang Kancil and Buaya: an Interactive Animation
Bakhir, N. M., Kamal, J. I., & Yusri, N. (2018) · International Conference Creative Media, Design & Technology · doi:10.2991/reka-18.2018.49 · Cited by 3
Milbury, K., Li, J., Weathers, S.-P. S., Shih, Y. T., Malliaha, S., Li, Y., & Cohen, L. G. (2019) · Pilot and Feasibility Studies · doi:10.1186/s40814-019-0479-5 · Cited by 3
Lowrey, K. L., Altman, C. E., & Jungmeyer, A. (2020) · Child & Youth Care Forum · doi:10.1007/s10566-020-09580-3 · Cited by 3
Wang, J. (2020) · REVISTA ARGENTINA DE CLINICA PSICOLOGICA · doi:10.24205/03276716.2020.841 · Cited by 3
Estrategia artística para mejorar la expresión oral en estudiantes mexicanos: un estudio piloto
Calles, T. J. G., Sánchez, H. F., Cruz, H. B., et al. (2021) · Diálogos sobre educación · doi:10.32870/dse.v0i23.779 · Cited by 3
Funk, L. M., Breuer, C. R., Venkatesh, M., et al. (2021) · Contemporary Clinical Trials Communications · doi:10.1016/j.conctc.2021.100816 · Cited by 3
“Our a priori sample size was at least 40 participants, which we determined would be sufficient to evaluate study design feasibility and acceptability [28].”
BackgroundThomas, E. C., Suarez, J., Lucksted, A. A., Siminoff, L. A., Hurford, I. M., Dixon, L. B., O’Connell, M. J., Penn, D. L., & Salzer, M. S. (2021) · Pilot and Feasibility Studies · doi:10.1186/s40814-021-00927-8 · Cited by 3
“Given that this study’s purpose is to collect preliminary data about the intervention’s engagement of targets, the sample size is based on pragmatics rather than power, consistent with recommendations for pilot studies [96].”
ResultSackinger, D., Carlin, K. E., & Zierler, B. K. (2021) · Journal of Pediatric Nursing · doi:10.1016/j.pedn.2021.12.013 · Cited by 3
Krukowski, R. A., Johnson, B. M., Kim, H., Sen, Ś., & Homsi, R. (2021) · JMIR Formative Research · doi:10.2196/30578 · Cited by 3
“Power Estimates This is a feasibility study, the primary purpose of which is to gather data that would evaluate the feasibility of recruitment, randomization, and retention, as well as treatment engagement and intervention satisfaction [47].”
BackgroundMcNamara, P. S., Clayton, D., Burchett, C., et al. (2022) · PLoS ONE · doi:10.1371/journal.pone.0263044 · Cited by 3
Stoops, W. W., Johnson, M. F., Strickland, J. C., et al. (2019) · Community Dental Health · doi:10.1922/cdh_4474stoops03 · Cited by 3
“Consistent with recommended methods for conducting and analyzing pilot studies (Leon et al ., 2011; Thabane et al. , 2010), the primary outcome was feasibility of saliva sample collection, defined a priori as dental practice staff collecting and mailing sufficient samples for 80% of enrolled…”
Gantschnig, B. E. (2014) · Zürcher Hochschule für Angewandte Wissenschaften digital collection (Zurich University of Applied Sciences) · Cited by 3
Sambu, L. (2015) · Unisa Institutional Repository (University of South Africa) · Cited by 3
Examining Productive Failure Instruction in Dental Ethics
Tam, K. (2017) · UA Campus Repository (The University of Arizona) · Cited by 3
Factors Influencing Malaysian Youth Consumers’ Online Purchase Intention of Travel Products
Tee, Y. T. (2018) · Cited by 3
Sustainable business strategy for small and medium enterprises in KwaZulu-Natal, South Africa
Bugwandin, V. (2022) · doi:10.51415/10321/4245 · Cited by 3
Mehta, T., John, T., El Zein, A., Faught, V., Nawshin, T., Chilke, T. S., Cohen, C. W., Cherrington, A., & Thirumalai, M. (2025) · JMIR Research Protocols · doi:10.2196/70271 · Cited by 2
“The primary objective of this feasibility study is not to serve as a definitive, well-powered trial, but to conduct a pilot study that is sufficiently large to estimate design parameters, as well as assess feasibility parameters, such as attrition rate, adherence, and pre-post correlation [58-60].”
Correa-Fernández, V., Blalock, J. A., Piper, M. E., Canino, G., & Wetter, D. W. (2023) · JMIR Research Protocols · doi:10.2196/44146 · Cited by 2
Anthenelli, R. M., McKenna, B. S., Giannini, J., Attaluri, S. V., Rubin, M., O’Crowley, E., Miller, S., & Heffner, J. L. (2023) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2023.111012 · Cited by 2
Bartolo, C. A. D., Abikoff, H., McDonald, M., & Gallagher, R. (2021) · Psychology in the Schools · doi:10.1002/pits.22530 · Cited by 3
Shepherd‐Banigan, M. E., Shapiro, A. S., Stechuchak, K. M., Glynn, S. M., Calhoun, P. S., Ackland, P. E., Bokhour, B. G., Edelman, D. E., Falkovic, M., Weidenbacher, H. J., et al. (2024) · Psychological Trauma Theory Research Practice and Policy · doi:10.1037/tra0001623 · Cited by 2
Dopp, A. R., North, M. N., Gilbert, M., Ringel, J. S., Silovsky, J. F., Blythe, M., Edwards, D., Schmidt, S. R., & Funderburk, B. W. (2024) · Implementation Research and Practice · doi:10.1177/26334895241249394 · Cited by 3
“The mixed-method approach was qualitative and quantitative (qualitative-dominant) and examined convergence between data sources; we emphasized qualitative data more because the quantitative effects from small pilot studies are not reliable indicators of effects (Leon et al., 2011).”
BackgroundMethodRuangsomboon, O., Lima, J. P., Eltorki, M., & Worster, A. (2024) · BMJ Open · doi:10.1136/bmjopen-2023-082648 · Cited by 4
Corti, C., Papini, M., Strazzer, S., Borgatti, R., Romaniello, R., Poggi, G., Storm, F. A., Urgesi, C., Jansari, A. S., Wade, S. L., et al. (2024) · JMIR Research Protocols · doi:10.2196/64178 · Cited by 2
“These measures have been developed for a previous study [60] based on the relevant literature on pilot feasibility studies [62,63].”
Kho, K. L., Lewis, A. J., & Almeida, R. A. (2024) · Children · doi:10.3390/children11121552 · Cited by 3
The Impact of Psychiatric Boarding in the Emergency Department: A Mixed-Methods Study
Hong, V., Harness, J. A., Cranford, J. A., Cervantes, V., Czyz, E. K., Bailey, J., Burke, N., Malas, N., & Rogers, A. (2025) · Hospital Pediatrics · doi:10.1542/hpeds.2024-008065 · Cited by 3
Effect of mixed-reality therapy on finger movement function of hemiplegic stroke patients
Sasaki, S., Takahira, N., Yoda, C., et al. (2025) · Frontiers in Virtual Reality · doi:10.3389/frvir.2025.1559755 · Cited by 2
Proof of concept studies in mental health systems research: strategy and steps
Salvador‐Carulla, L., Tabatabaei‐Jafari, H., Woods, C., & Lukersmith, S. (2025) · International Journal of Mental Health Systems · doi:10.1186/s13033-025-00682-w · Cited by 2
“…comprehensive results or solutions but rather to show that the application is worthy of further investment, to identify potential issues, and refine the study design prior to developing a prototype that could be tested in a small-scale pilot study before being demonstrated in the real world [8, 9].”
Ramos, K., Ayaz, A., Riley, J. A., Faircloth, K., Porter, L. S., & Strauman, T. J. (2025) · Cancers · doi:10.3390/cancers17172809 · Cited by 2
“While a single-arm, small-sample design may be appropriate for testing feasibility and acceptability, it is underpowered to detect clinically significant effects [42].”
Murphy, E., Dakhili, A. H., Ganesan, S., Zalesky, A., Glarin, R. K., Thomson, H. M., Paloubis, A., Kamboj, S. K., Moffat, B. A., Poudel, G. R., et al. (2025) · BMJ Open · doi:10.1136/bmjopen-2025-105854 · Cited by 3
Quilghini, C., Lefflot, J., & Buchholtz, K. (2025) · Frontiers in Rehabilitation Sciences · doi:10.3389/fresc.2025.1647927 · Cited by 2
Kraemer, K. M., Litrownik, D., Wayne, P. M., Richardson, C. R., Bhomia, N., Kadri, R., Rist, P. M., Ngo, L. H., Moy, M. L., & Yeh, G. Y. (2025) · JMIR Formative Research · doi:10.2196/74118 · Cited by 3
“In line with guidelines for pilot trials [49], findings”
Bialostocki, L. S., Adhia, D. B., Mudiyanselage, D. R., Smith, M. L., Çakmak, Y. Ö., Ridder, D. D., Mani, R., & Mathew, J. (2025) · JMIR Research Protocols · doi:10.2196/78806 · Cited by 2
“The primary focus is to gather preliminary data on EEG-NF training implementation and variability in clinical outcomes, which will inform a future fully powered clinical trial [58-60].”
Bolt, G. L., Rowland, B., Piercy, H., Bradshaw, J., Lubman, D. I., & Manning, V. (2025) · Addictive Behaviors · doi:10.1016/j.addbeh.2025.108560 · Cited by 3
Zhang, Y., Revol, J., Lafit, G., Ernst, A. F., Razum, J., Ceulemans, E., & Bringmann, L. F. (2025) · Advances in Methods and Practices in Psychological Science · doi:10.1177/25152459251372116 · Cited by 5
“The reason lies in the uncertainty of the effect size estimated from samples, especially from small samples (Leon et al., 2011).”
Chapter 4.5: New Proposed Treatments for Pelvic Organ Prolapse
Alperin, M., Fitz, F. F., Gargett, C. E., Güler, Z., Iglesia, C. B., Kisby, C. K., Lozo, S., Valentín Manríquez, G., Prasad, S., Swenson, C. W., et al. (2025) · International Urogynecology Journal · doi:10.1007/s00192-025-06450-1 · Cited by 2
“Pilot results can inform feasibility and identify modifications needed in the design of a larger, ensuing hypothesis testing study [239].”
Kumari, S., & Kakkad, A. D. (2025) · Physiotherapy Quarterly · doi:10.5114/pq/200046 · Cited by 2
“Given the pilot nature of the study, a sample size of 12 participants was determined to be sufficient to observe potential trends in the effectiveness of the intervention, allowing for an exploratory analysis of the data [8].”
Agboji, A., Freeman, S., Banner, D., Armstrong, J. J., Martin‐Khan, M., & Freeman-Idemilih, A. (2025) · Geriatrics · doi:10.3390/geriatrics11010001 · Cited by 2
“While the single-group design limits internal validity, it was deemed appropriate for this early stage of program development [36].”
Exploring neglected places enabling conservation crime through place network investigations
Xu, E., Cao, D. T. T., Xu, X., et al. (2025) · iScience · doi:10.1016/j.isci.2025.114384 · Cited by 2
Levels of Validity and Reliability
Zumitzavan, V. (2025) · Springer eBooks · doi:10.1007/978-981-95-4318-2_4 · Cited by 2
Generalized Technology Readiness Level Scale for Measuring Technology Maturity
Townes, M. S. (2026) · Journal of Research Management and Administration · doi:10.18552/jorma.v5i1.1285 · Cited by 2
Veldheer, S., Rutt, K., Schaefer, E. W., Kim, I., Hrabovsky, S., Smith, B., Thomas, O. W., Moore, A. M., Pagoto, S., Conroy, D. E., et al. (2026) · Pilot and Feasibility Studies · doi:10.1186/s40814-026-01766-1 · Cited by 2
“Pilot studies are not designed to be fully powered or test hypotheses and formal power calculations are not required [37, 38].”
Oviedo, V., Alegría, L., Leonard, D., Cádiz, R., Brockmann, P., Repetto, P. B., Henríquez, M., Gonzalo Labarca, T., Carrasco, M., Moya, A. G., et al. (2026) · Intensive and Critical Care Nursing · doi:10.1016/j.iccn.2026.104349 · Cited by 2
Schaefers, A., Beattie, C. M., de Mello, G. T., George, A., Marstall, K., Gardner, J., & Szeszulski, J. (2026) · Implementation Science · doi:10.1186/s13012-026-01487-2 · Cited by 3
“Best practices suggest that pilot studies focus on logistics and refinement of implementation protocols, which we will iteratively address through this study [68].”
Gilliland, J., Bowman, D., Cappuccitti, S., Caruso, O., Clark, A., Doherty, S., Haines, J., McEachern, L. W., Minaker, L. M., O’Connor, C., et al. (2026) · Pilot and Feasibility Studies · doi:10.1186/s40814-026-01767-0 · Cited by 2
“Since this is a pilot study with a small sample size that is not representative of a broader population, no conclusions regarding the effectiveness of SmartAPPetite in changing behavior are drawn [56].”
Majumdar, J. R., Strauss, S. M., Strah, T. M., Mendez, C. M., Fromkin, J. B., Dannaoui, A., Caramore, A., O’Leary, J., Liou, K. T., & Barton‐Burke, M. (2026) · Seminars in Oncology Nursing · doi:10.1016/j.soncn.2026.152149 · Cited by 2
Lee, D. E. Z., Nyauchi, B., Kihiu, M., Kimathi, R., Okoth, E. A., Chazara, A., Barkley, C., Dallos, A., Waruinge, S., Oyaro, P., et al. (2026) · Frontiers in Public Health · doi:10.3389/fpubh.2026.1746268 · Cited by 3
“When combined with qualitative data, the ITS design provides valuable early evidence to inform a future, adequately powered trial (20, 21).”
Brief Prescribing Support and Buprenorphine Adoption in Rural Primary Care
Franz, B. A., Dhanani, L. Y., Brook, D., et al. (2026) · JAMA Network Open · doi:10.1001/jamanetworkopen.2026.3050 · Cited by 2
Evaluating Treatment Outcomes Using the Integrative Model of Brief Couples Counseling
Gutiérrez, D., Carlson, R. G., Daire, A. P., et al. (2016) · The Family Journal · doi:10.1177/1066480716678619 · Cited by 2
Exploring Provider Cultural Competence and Patient Mood in an Outpatient Apheresis Unit
Bennett, E., Stutzman, S. E., Hicks, A. D., & Olson, D. M. (2019) · Journal of Transcultural Nursing · doi:10.1177/1043659619838026 · Cited by 2
Bidirectional associations between Tibetan Buddhism and vertical space.
Guan, F., Xu, Z., Zhang, B., Yan, W., & Peng, K. (2020) · Psychology of Religion and Spirituality · doi:10.1037/rel0000367 · Cited by 2
Can dental students increase oral health knowledge of the homeless population?
Chandrasekara, B., Carnley, A., & Csikar, J. I. (2021) · Faculty Dental Journal · doi:10.1308/rcsfdj.2021.35 · Cited by 2
The Validation of the Information Systems Success Model: LMS Integration during Covid-19
Miftahuddin, M., Prasojo, L. D., & Akalili, A. (2021) · Indonesian Research Journal in Education |IRJE| · doi:10.22437/irje.v5i2.15300 · Cited by 2
“Afterwards, the instrument indicators was validated through content validity and distributed for a pilot study (Hazzi & Maaldaon, 2015; Leon et al., 2011).”
MethodAtrial fibrillation cardiac radioablation target visibility on magnetic resonance imaging
Lydiard, S., Pontré, B. P., Lowe, B. S., et al. (2022) · Physical and Engineering Sciences in Medicine · doi:10.1007/s13246-022-01141-3 · Cited by 2
“However, the importance of pilot studies in the overall research process is recognized despite the inherent limitations of pilot studies [30].”
BackgroundStory, K. M., Bravata, D. M., Robb, S. L., Wasmuth, S., Slaven, J. E., Whitmire, L., Barker, B. C., Menen, T., & Bair, M. J. (2022) · JMIR Research Protocols · doi:10.2196/38788 · Cited by 5
“A sample size of 15 to 20 per group is sufficient to assess the feasibility and acceptability in pilot trials [34].”
Evaluation of a Brief Attachment-Based Parenting Program: Aware Parenting
Baltrotsky, K., Bradbury, J., Rose, M., Grace, S., & Doran, F. M. (2022) · Child & Family Behavior Therapy · doi:10.1080/07317107.2022.2141600 · Cited by 2
“Although control groups are generally not required for a pilot study (Leon et al., 2011), an active control was used in this study to help inform the development of a large future study.”
MethodNason, E. E., Trahan, M. H., & Cash, D. (2022) · Journal of Technology in Behavioral Science · doi:10.1007/s41347-022-00292-0 · Cited by 2
“The primary limitations of the current study are consistent with the primary limitations of pilot studies more generally— that is, the limited sample size does not allow for conclusive determination of the effectiveness or safety of an intervention (Leon et al., 2011).”
ResultDeveloping, Evaluating and Implementing Evidence-Based Interventions in Real World Practice.
Aschbrenner, K. A., & Torrey, W. C. (2022) · Springer eBooks · doi:10.1007/978-3-031-10239-4_21 · Cited by 3
Fernández, D., Grandón, P., & Bustos, C. (2023) · International Journal of Clinical Trials · doi:10.18203/2349-3259.ijct20230050 · Cited by 1
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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