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
Porta, M. (2026) · doi:10.1093/acref/9780197663639.001.0001 · Cited by 2,175
Fundamentals of Clinical Trials
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
Sorted by citations
Items 1,201–1,300 of 1,903
Ma, Y., Yang, H., Vazquez, M. A., Buraks, O., Haack, M., Mullington, J. M., & Goldstein, M. R. (2023) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph20043180 · Cited by 2
“Per the guidelines for feasibility studies set forth by the NCCIH and others [57], we did not power this study for testing the intervention efficacy or group-wise differences, thus we only report the descriptive statistics and data visuals here.”
MethodAlenazi, F., Peddle, M., Bressington, D. T., Mahzari, M. M., & Gray, R. J. (2023) · Pilot and Feasibility Studies · doi:10.1186/s40814-023-01294-2 · Cited by 1
“Feasibility sample size As we are reporting a feasibility study, a formal sample size calculation was not undertaken [44].”
BackgroundMcGuier, E. A., Aarons, G. A., Wright, J. D., Fortney, J. C., Powell, B. J., Rothenberger, S. D., Weingart, L. R., Miller, E. A., & Kolko, D. J. (2023) · Implementation Science Communications · doi:10.1186/s43058-023-00437-z · Cited by 2
Measuring Financial Planning for Retirement of Gig Workers in Malaysia: A Pilot Study
Aizad, M. E., Ismail, S. B., & Samad, K. B. A. (2023) · Information Management and Business Review · doi:10.22610/imbr.v15i3(i).3543 · Cited by 2
“According to Leon et al. (2011), pilot studies play a significant role in the development of interventions and, when interpreted correctly, can increase the effectiveness and validity of subsequent clinical trials by improving subject recruitment, intervention delivery, and by enabling researchers…”
BackgroundMcDonnell, K. K., Andrews, J. O., Yang, C., Newsome, B. R., Weinkle, E., Davis, J. E., & DUNSIGER, S. I. (2023) · Integrative Cancer Therapies · doi:10.1177/15347354231212876 · Cited by 2
“33,34”
BackgroundInfluentialSnowdon, D. A., Wang, Y. T., Callisaya, M. L., Collyer, T. A., Jolliffe, L. J., Johns, N. A., Vincent, P., Pragash, N., & Taylor, N. F. (2024) · BMJ Open · doi:10.1136/bmjopen-2023-078843 · Cited by 2
Latimer, S. L., Bone, M., Walker, R., et al. (2024) · Nursing Open · doi:10.1002/nop2.2103 · Cited by 2
“The investigative nature of this study meant a small sample size of 20 participants was deemed sufficient (Bland & Altman, 1999 ; Leon et al., 2011).”
BackgroundWeissman, R. S., Scott, B. G., Edwards, K., Rose, J. S., Kuntz, M., & Wilcox, H. C. (2024) · Discover Psychology · doi:10.1007/s44202-024-00140-7 · Cited by 3
“As recommended in a seminal paper on pilot studies [82], because they are by definition underpowered, pilot studies should not use control groups for the primary purpose of testing the differential efficacy of the novel versus original intervention.”
Kelechi, T. J., Layne, D. M., Mueller, M., Madisetti, M., & Balasubramanian, S. (2024) · Western Journal of Nursing Research · doi:10.1177/01939459241247926 · Cited by 2
Bauer, L., Wienke, A., & Führer, A. (2024) · BMC Medical Education · doi:10.1186/s12909-024-05684-9 · Cited by 4
“Both stems were piloted with a group of 13 medical students that were from another semester than the ones recruited for the study to avoid data contamination [67].”
BackgroundO’Hara, K. L., Guastaferro, K., Hita, L., Rhodes, C. A., Thomas, N. A., Wolchik, S. A., & Berkel, C. (2024) · Implementation Research and Practice · doi:10.1177/26334895241262822 · Cited by 2
“Experimental pilot studies can be used to examine the acceptability and feasibility of recruiting, retaining, and randomizing participants in a complex experimental design (Leon et al., 2011).”
BackgroundMethodFocusing with colorectal cancer patients: a pilot study of a brief online group intervention
Gomes, M., Silva, E., & Salgado, J. (2024) · Frontiers in Psychology · doi:10.3389/fpsyg.2024.1339823 · Cited by 2
“Small sample sizes can lead to less precise results, which may affect the accuracy of Cohen’s d effect size estimates (Bradley et al., 2002; Leon et al., 2011).”
BackgroundAtayan, A., Huerne, K., Palmour, N., & Joly, Y. (2024) · BMC Medical Education · doi:10.1186/s12909-024-05898-x · Cited by 3
“The interview guide was piloted by GC students who closely resembled the study’s intended demographic to maximize the content validity, assess the appropriateness of questions and estimate approximate interview length [42].”
MethodSmid, M. C., Seliski, N., Charles, J. E., Castro, S., Humiston, G. E., Cash, E., Allshouse, A. A., Turner, E. L., Carlston, K., Gibson, M., et al. (2024) · Contemporary Clinical Trials Communications · doi:10.1016/j.conctc.2024.101359 · Cited by 2
“Sample size is based on a power estimate for feasibility [35,36] and the number of potential participants who can be screened and consented within the study timeframe.”
BackgroundSeoane, M. C., Jake‐Schoffman, D. E., Mobley, A. R., & McVay, M. A. (2024) · Journal of Immigrant and Minority Health · doi:10.1007/s10903-024-01632-3 · Cited by 2
“Because this was a pilot study that was underpowered to evaluate statistical significance, we cannot make conclusions about the effectiveness of the intervention [ 44].”
Williams, N. J., Cardamone, N. C., Beidas, R. S., & Marcus, S. C. (2024) · Implementation Research and Practice · doi:10.1177/26334895241279153 · Cited by 3
“This leads investigators to develop power analyses based on crude rules of thumb (Killip, 2004) or on unreliable estimates from small pilot studies (Hedges & Hedberg, 2007; Killip, 2004; Kraemer et al., 2006; Leon et al., 2011).”
BackgroundWilliams, J., McGrath, R., Ang, K., Bakolis, I., Healey, A., de la Torre, J. A., Mdudu, I., Gaughran, F., Sadler, E., da Costa, M. P., et al. (2024) · BJPsych Open · doi:10.1192/bjo.2024.746 · Cited by 2
Womack, J. A., Leblanc, M. M., Sager, A. S., Zaets, L., Maisto, S. A., Garcia, A., Barakat, L., Brown, S.-E., Edelman, E. J., Fiellin, D. A., et al. (2024) · AIDS and Behavior · doi:10.1007/s10461-024-04533-6 · Cited by 2
Greenberg, J., Levey, N., Becker, M. E., Yeh, G. Y., Giacino, J. T., Iverson, G. L., Silverberg, N. D., Parker, R. A., & Vranceanu, A. (2024) · Archives of Physical Medicine and Rehabilitation · doi:10.1016/j.apmr.2024.10.011 · Cited by 2
Gamarel, K. E., Mayo‐Wilson, L. J., Jadwin-Cakmak, L. A., Reyes, L. A., Monro, D., Ubong, I.-A., Sullivan, S., Abad, J., Poindexter, J., Harris, H., et al. (2024) · Pilot and Feasibility Studies · doi:10.1186/s40814-024-01558-5 · Cited by 2
“Hypothesis testing will be de-emphasized in line with NIH [79] and research methods literature cautions [80, 81] regarding the instability of inferential results from small-scale pilot studies.”
BackgroundTabaczynski, A., Sabiston, C. M., Arbour‐Nicitopoulos, K. P., Rhodes, R. E., & Trinh, L. (2024) · OBM Integrative and Complementary Medicine · doi:10.21926/obm.icm.2404067 · Cited by 2
Rethorst, C. D., Trombello, J. M., Chen, P. M., Carmody, T. J., Goodman, L. C., Lazalde, A., & Trivedi, M. H. (2024) · BMC Psychology · doi:10.1186/s40359-024-02053-5 · Cited by 3
“Based on the guidelines for pilot studies established by Leon et al., [40] the primary goal of the pilot study was to assess feasibility and acceptability of the study intervention and procedures.”
MethodAlnooh, G., ALTAMIMI, J. Z., Williams, E. A., & Hawley, M. (2024) · JMIR Formative Research · doi:10.2196/60037 · Cited by 2
“The purpose of this study was not to detect effects using inferential statistical tests; therefore, power calculations were not performed [42].”
Stevenson, B. J., Reed, C., Falcón, A. K., Hunt, T., Kathawalla, U., Mueller, L. N., McNary, K., Wilkins, S., & Blustein, D. L. (2025) · Journal of Career Development · doi:10.1177/08948453241313192 · Cited by 2
“Participating in an Open Trial Pilot studies are an important component of developing and re fi ning interventions (Leon et al., 2011).”
Universal parent-focused child sexual abuse prevention: A quasi-experimental protocol
Abourjaily, E., Guastaferro, K., McElwee, K., & Connell, C. M. (2025) · PLoS ONE · doi:10.1371/journal.pone.0314459 · Cited by 2
Schroeder, M. W., Frumkin, M. R., & Mace, R. A. (2025) · Journal of Behavioral Medicine · doi:10.1007/s10865-024-00546-7 · Cited by 2
“Consistent with the NIH Stage Model and guidelines for pilot studies (Lancaster et al., 2004; Leon et al., 2011) our study was designed to assess the feasibility of the intervention and assessments.”
Pollak, C., Blumen, H. M., Zhou, L., Wong, J., Jin, Y., Bhattiprolu, A., Anfang, S., & Ceïde, M. E. (2025) · JMIR Research Protocols · doi:10.2196/70518 · Cited by 4
“RenderX feasibility [51].”
Schulz, F., Hultin, M., & Gyllencreutz, L. (2025) · BMJ Open · doi:10.1136/bmjopen-2024-098284 · Cited by 2
“These findings suggest that the instrument is suitable for use in disaster response training programmes.”
Lindsay, H., Humar, M., Anderson, D. J., et al. (2025) · Air Medical Journal · doi:10.1016/j.amj.2025.03.009 · Cited by 2
Liu, T. W., Wong, B. Y.-M., Yam, T. T. T., Tsang, W. W. N., Tse, G., Kwan, Q. C. M., Hung, K., Chui, K. T., Wu, H., Leung, C. P., et al. (2025) · European Geriatric Medicine · doi:10.1007/s41999-025-01294-w · Cited by 4
“A 3-month follow-up was selected based on prior pilot RCTs demonstrating that this duration is sufficient to observe preliminary changes in outcomes while balancing participant retention [20].”
Manway, M., Blackburn, S., Barr, J., Hull, E. E., Averitte, R. L., & Ahn, Y. (2018) · Journal of Complementary and Integrative Medicine · doi:10.1515/jcim-2018-0021 · Cited by 3
Genetic testing and results disclosure in diverse populations: what does it take?
Horowitz, C. R. (2020) · Genetics in Medicine · doi:10.1038/s41436-020-0874-6 · Cited by 2
“PILOT TESTING Pilot testing can determine feasibility and allow for early identification and modifications of problem areas.(3) In this”
MethodKnabb, J. J., Pate, R. A., Sullivan, S. P., Salley, E. R., Miller, A. L., & Boyer, W. R. (2020) · Mental Health Religion & Culture · doi:10.1080/13674676.2020.1819221 · Cited by 2
Luciano, M. T., McDevitt‐Murphy, M. E., Murphy, J. G., Zakarian, R. J., & Olin, C. C. (2022) · Journal of Behavioral and Cognitive Therapy · doi:10.1016/j.jbct.2022.02.004 · Cited by 2
Ferguson, R. E., & Brophy, M. T. (2017) · Springer eBooks · doi:10.1007/978-3-319-53877-8_27 · Cited by 2
K.A.P.S.: A Disaster Training Approach for High-Risk Communities
Semien, J., & Nance, E. (2019) · International Journal of Mass Emergencies & Disasters · doi:10.1177/028072701903700302 · Cited by 2
Insignificant influence of test order on cognitive behavior in Wistar rats
Makmor‐Bakry, M., Ahmad, N., Azmi, N., & Yow, H.-Y. (2014) · Journal of Pharmaceutical Negative Results · doi:10.4103/0976-9234.136790 · Cited by 2
Gantschnig, B. E., Nilsson, I., Fisher, A. G., Küenzle, C., & Page, J. (2015) · Scandinavian Journal of Occupational Therapy · doi:10.3109/11038128.2015.1115548 · Cited by 2
“Feasibility studies are not designed to test intervention hypotheses [6–8,10] or to estimate effect sizes [7].”
BackgroundMethodFeasibility and Smokers’ Evaluation of Self-Generated Text Messages to Promote Quitting: Table 1.
Shaw, R. J., Pollak, K. I., Zullig, L. L., Bennett, G. G., Hawkins, K., & Lipkus, I. M. (2015) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntv268 · Cited by 2
Butler, J. L. (2017) · Digital Commons (Liberty University) · Cited by 2
Buis, L. R., Roberson, D. N., Kadri, R., Rockey, N. G., Plegue, M. A., Choe, H. M., & Richardson, C. R. (2017) · JMIR Research Protocols · doi:10.2196/resprot.8059 · Cited by 3
“As highlighted by Leon et al, “the primary role of a pilot study is to example the feasibility of a research endeavor” [21].”
Level 1 Evidence: A Prospective Randomized Controlled Study
Ekhtiari, S., Mundi, R., Khanna, V., & Bhandari, M. (2019) · Springer eBooks · doi:10.1007/978-3-662-58254-1_29 · Cited by 2
A pilot study of interpersonal process group therapy for PTSD in Canadian Veterans
van Reekum, E. A., & Watt, M. C. (2019) · Journal of Military Veteran and Family Health · doi:10.3138/jmvfh.2018-0001 · Cited by 2
Siedlecki, S. L. (2019) · Clinical Nurse Specialist · doi:10.1097/nur.0000000000000468 · Cited by 2
“Although sometimes seen in the literature,(4) it is important to note that neither pilot nor feasibility studies can answer questions about the effectiveness or efficacy of an intervention.(1,4,5)”
BackgroundMethodResultInfluentialUllman, A. J., & Letton, G. (2014) · Griffith Research Online · Cited by 2
Kim, H. C., Pollack, L. M., Saberi, P., Neilands, T. B., Arnold, E. A., Bright, D. J., Williams, R. W., Kegeles, S. M., & Tan, J. Y. (2021) · BMJ Open · doi:10.1136/bmjopen-2021-055448 · Cited by 2
A comprehensive mobile health intervention to prevent and manage the complexities of opioid use
Singh, N., Dube, S. R., Varshney, U., & Bourgeois, A. G. (2022) · International Journal of Medical Informatics · doi:10.1016/j.ijmedinf.2022.104792 · Cited by 2
Ajani, T. (2022) · Journal of Mental Health and Social Behaviour · doi:10.33790/jmhsb1100164 · Cited by 2
Wolf, F., Nielsen, J., Saliger, J., Hennecken, E., Eschweiler, M., Folkerts, A., Karbe, H., & Zimmer, P. (2022) · BMJ Open · doi:10.1136/bmjopen-2022-062160 · Cited by 3
Muyambo, T. M., Sande, N., & Tendere, J. (2022) · Journal of Religion in Africa · doi:10.1163/15700666-12340234 · Cited by 2
Maeresera, S. (2022) · Journal of Psychiatry Research Reviews & Reports · doi:10.47363/jpsrr/2022(4)137 · Cited by 2
Antecedents of Self-Protective Behavior during the COVID-19 Pandemic in Bangladesh
Khanam, L., Sorwar, G., & Mahfuz, M. A. (2022) · WHO South-East Asia Journal of Public Health · doi:10.4103/who-seajph.who-seajph_172_21 · Cited by 2
Govender, L., Siwela, M., & Denhere, S. (2022) · Diversity · doi:10.3390/d14121088 · Cited by 2
Effects of Sociodemographic Variables on Electronic Word of Mouth: Evidence from Emerging Economies
Mladenović, D., Rrustemi, V., Martin, S., Kalia, P., & Chawdhary, R. (2022) · MUNI ECON Working Papers · doi:10.5817/wp_muni_econ_2022-02 · Cited by 3
Mathew, A. R., Avery, E., Cox, C. M., Nwanah, P., Kalhan, R., Hitsman, B. L., & Powell, L. H. (2023) · Journal of Behavioral Medicine · doi:10.1007/s10865-023-00411-z · Cited by 2
“…pilot studies are appropriate primarily for testing the proof-of-concept and feasibility/ acceptability of an approach to be used in a larger scale study (Bowen et al., 2009), and not to test hypotheses about the effects of an intervention or to estimate effect sizes (Leon, Davis, & Kraemer, 2011).”
Vance, D. E., Fazeli, P. L., Azuero, A., Khalidi, S., Frank, J., Wadley, V. G., Raper, J. L., Pope, C. N., Jacob, A. E., & Ball, K. (2023) · Applied Neuropsychology Adult · doi:10.1080/23279095.2023.2209900 · Cited by 2
Feasibility of Integrating MEditatioN inTO heaRt Disease (the MENTOR Study)
Rao, A., Zecchin, R. P., Newton, P. J., Read, S. A., Phillips, J. L., DiGiacomo, M. L., Chang, S., Denniss, A. R., & Hickman, L. (2023) · The Journal of Cardiovascular Nursing · doi:10.1097/jcn.0000000000000997 · Cited by 2
“The pilot sample size was determined based on the pragmatics of recruitment and the necessities for examining feasibility.(57) This pilot study initially aimed to recruit 60 participants.”
MethodStefanini, M., Cagnazzi, E., Calza, S., et al. (2023) · Journal of Anesthesia Analgesia and Critical Care · doi:10.1186/s44158-023-00112-8 · Cited by 2
“Due to the pilot nature of this study, an estimation of the size sample was not done [19].”
BackgroundSTEL Practice and the Integration of Tinkering and Take Apart in the Elementary Classroom
Cheek, L. R., Carter, V., & Daugherty, M. K. (2022) · The Journal of Technology Studies · doi:10.21061/jts.403 · Cited by 2
Chang, H.-H., Chen, S., Hsu, C.-A., et al. (2023) · Retina · doi:10.1097/iae.0000000000004008 · Cited by 2
Factors affecting students’ concept retention in learning science online using instructional videos
Aguanta, C. B., Augusto, M. A. T., Bajenting, J. V., et al. (2024) · Journal of Education and Learning (EduLearn) · doi:10.11591/edulearn.v18i2.21117 · Cited by 2
“A pilot test was conducted before the actual study with 20 students [19].”
MethodSilverstein, S. M., Atlas, J., Young, M., Bertolace, L., Juskiewicz, I., Merchant‐Borna, K., Dermady, S., Abrham, Y. T., Green, K., Bazarian, J., et al. (2024) · Biomarkers in Neuropsychiatry · doi:10.1016/j.bionps.2024.100091 · Cited by 3
Thamage, M., & Motshegwa, B. (2021) · Journal of Public Administration and Development Alternatives · doi:10.55190/fwtw8596 · Cited by 2
Maternal and Child Health Access Disparities Among Recent African Immigrants in the United States
Mukasa, B. (2016) · ScholarWorks (Walden University) · Cited by 2
Klompstra, L. V. (2016) · Linköping University medical dissertations · doi:10.3384/diss.diva-130933 · Cited by 2
Rodi, W. N. W., Ani, A. I. C., Tawil, N. M., Ting, K., & Mahamood, N. M. (2018) · Journal of Fundamental and Applied Sciences · doi:10.4314/jfas.v9i6s.14 · Cited by 2
“The use of descriptive statistics was justified since this study is not a hypothesis testing study [61] and preliminary as in pilot study research should only perform the descriptive statistics [62-63] to clarify the purpose of certain incident or situation.”
MethodParent-based prevention after parental weight loss surgery: a pilot case-series trial
Sadeh‐Sharvit, S., Runfola, C. D., Welch, H. A., Gibbs, E. L., Dickens, C. E., Lock, J., & Safer, D. L. (2020) · Surgery for Obesity and Related Diseases · doi:10.1016/j.soard.2020.05.016 · Cited by 2
Prevalence of maternal tachycardia during late pregnancy
Nel, N. A. (2012) · SUNScholar (Stellenbosch University) · Cited by 2
Ng, L.-P. (2015) · UUM Electronic Theses and Dissertation [eTheses] (Northern University of Malaysia) · Cited by 2
Lying (or Maybe Just Misleading) With (or Without) Statistics
Baranowski, T. (2014) · Games for Health Journal · doi:10.1089/g4h.2014.1713 · Cited by 3
Yoo, J. (2018) · KU ScholarWorks (The University of Kansas) · Cited by 2
Millar, M.-L. (2019) · DUT Open Scholar (Durban University of Technology) · doi:10.51415/10321/3221 · Cited by 2
“4%, depending on the age of the runner and their previous running experience (Cheung & Davis, 2011; Lopes et al., 2012; Hespanhol, Pena Costa and Dias Lopes, 2013). Hoffman & Krishnan (2014) reported an annual incidence rate of 5.”
BackgroundOlhaberry, M., Leyton, F., Morán, J., León, M. J., Sieverson, C., Muzard, A., Honorato, C., Ensink, K., Malberg, N. T., Luyten, P., et al. (2021) · Research Square · doi:10.21203/rs.3.rs-458921/v1 · Cited by 2
Baig, M. R., Wilson, J. L., Beck, R. D., Lemmer, J. A., Meraj, A., Hernandez, A., Meyer, E. C., Mintz, J., Peterson, A. L., & Roache, J. D. (2021) · Research Square · doi:10.21203/rs.3.rs-812267/v1 · Cited by 2
A two-stage Bayesian sequential assessment of exploratory hypothesesPreprint
Stefan, A. M., Lengersdorff, L., & Wagenmakers, E. (2022) · doi:10.31234/osf.io/qwuyf · Cited by 2
Giusti, G., Proietti, S., Socarrás, M. E. R., et al. (2019) · European Urology · doi:10.1016/j.eururo.2019.02.012 · Cited by 2
Sidani, S., & Braden, C. J. (2021) · Wiley eBooks · doi:10.1002/9781119610113.ch12 · Cited by 2
How does Stakeholder Engagement and Social Capital Influence Project Performance Outcomes?
Arias, J. J. (2021) · FIU - Digital Commons (Florida International University) · doi:10.25148/etd.fidc010180 · Cited by 3
Qin, C., Li, Y., Qiu, S., et al. (2023) · Research Square · doi:10.21203/rs.3.rs-2903998/v1 · Cited by 2
Rodrigues, J. F. R., Rodrigues, L. P., da Silva, K. C. A., Rubatino, F. V. M., Fischer, H., Rodrigues, F. C. P., Júnior, E. G., Barbosa, P. M. K., Payão, S. L. M., de Godoy, M. F., et al. (2024) · Preprints.org · doi:10.20944/preprints202405.1144.v1 · Cited by 2
Mehta, A., Lockhart, S., Douglas, I. S., Mealer, M. L., & Matlock, D. D. (2025) · medRxiv · doi:10.1101/2025.02.24.25322755 · Cited by 2
Yusufov, M., Pirl, W. F., Greer, J. A., Mazzola, E., Dalrymple, K. L., Tulsky, J. A., Braun, I. M., & McHugh, R. K. (2024) · BMJ Open · doi:10.1136/bmjopen-2024-096546 · Cited by 1
Pfitzer, C., Ferentzi, H., Rosenthal, L., Kramer, P. P. G., Berger, F. F., & Schmitt, K. R. L. (2019) · Cardiology in the Young · doi:10.1017/s1047951119000787 · Cited by 1
Zhang, Y., Hu, H., Li, X., Lou, J., He, X., Jiang, Y., & Fang, J. (2021) · BMJ Open · doi:10.1136/bmjopen-2021-052528 · Cited by 1
Blok, A. C., Costa, D. K., Wright, N. C., et al. (2023) · Cancer Care Research Online · doi:10.1097/cr9.0000000000000043 · Cited by 1
Fogarty, S., McInerney, C., Chalmers, J., Veale, K., & Hay, P. (2023) · International Journal of Therapeutic Massage & Bodywork Research Education & Practice · doi:10.3822/ijtmb.v16i4.877 · Cited by 3
Blomquist, K. K., Ellison, W. D., Siddiqui, S., & Montgomery, K. (2023) · Body Image · doi:10.1016/j.bodyim.2023.101675 · Cited by 1
Palmer, R. F. (2024) · Journal of Xenobiotics · doi:10.3390/jox14010025 · Cited by 1
“Pilot/exploratory studies are performed prior to definitive trials to provide enough evidence of their overall potential intervention benefits [51,52].”
BackgroundRecommendations for optimising pilot and feasibility work in surgery
Fairhurst, K., Potter, S., Blazeby, J. M., & AVERY, K. N. L. (2024) · Pilot and Feasibility Studies · doi:10.1186/s40814-024-01489-1 · Cited by 1
“This finding indicates that the methodological work is poorly understood and not widely acknowledged beyond the methodological community [see Table 2 Quote 17].”
BackgroundInfluentialPalatnik, A., Sunji, N., Peterson, Z., Ohlendorf, J. M., Pan, A. Y., & Kulinski, J. P. (2024) · Contemporary Clinical Trials · doi:10.1016/j.cct.2024.107710 · Cited by 1
Lovette, B. C., Lyons, K. D., Greenberg, J., & Lopez, R. P. (2024) · Disability and Rehabilitation · doi:10.1080/09638288.2024.2423783 · Cited by 2
Kuruppu, N. R., Chaboyer, W. P., Tobiano, G., Abayadeera, A., & Ranse, K. (2024) · Intensive and Critical Care Nursing · doi:10.1016/j.iccn.2024.103891 · Cited by 2
Zhao, T., Tang, C., Ma, J., Halili, X., Huang, Y., & Wang, H. (2024) · Social Science & Medicine · doi:10.1016/j.socscimed.2024.117604 · Cited by 3
Togo, J. M., & Hurtado, T. M. (2024) · Cureus · doi:10.7759/cureus.75990 · Cited by 1
Pilot Testing Digital Stories to Influence College Men’s Intentions to Vaccinate Against HPV
Koskan, A. M., Venetis, M. K., & Kim, S. W. (2025) · Journal of Cancer Education · doi:10.1007/s13187-024-02563-1 · Cited by 1
“Additionally, including a control group would have further permitted us to examine other aspects for a future, larger randomized controlled trial, such as randomization, blinding procedures, control group participant retention, and intervention implementation [17].”
Gunderson, A. K., Mbusa, R. K., Baguma, E., Ayebare, E., Giandomenico, D., Reyes, R., Ntaro, M., Mulogo, E. M., & Boyce, R. M. (2025) · PLOS Global Public Health · doi:10.1371/journal.pgph.0003660 · Cited by 1
Bohlen, L. C., Oselinsky, K. M., Vornlocher, C., Lee, H., Michels, E., DUNSIGER, S. I., Bock, B. C., Kahler, C. W., & Williams, D. M. (2025) · Annals of Behavioral Medicine · doi:10.1093/abm/kaaf004 · Cited by 1
Siefried, K. J., Acheson, L. S., Clifford, B., Moller, C. I., Brett, J., Christmass, M. A., Dunlop, A. J., Haber, P., Jutras‐Aswad, D., Lintzeris, N., et al. (2025) · BMJ Open · doi:10.1136/bmjopen-2024-092032 · Cited by 1
“53 As this is a pilot study, we are undertaking qualitative interviews, to ensure that participant perspectives on the study design and conduct are incorporated in a larger, randomised controlled trial should this study demonstrate safety and feasibility.”
Fletcher, K., Ezard, N., Siefried, K. J., Macdonald, H., Acheson, L. S., Bedi, G., Guerin, A. A., Knock, E., Millard, M., May, R., et al. (2025) · BMJ Open · doi:10.1136/bmjopen-2024-092504 · Cited by 1
“As this is the first study of its kind in this population and pilot studies are not generalisable to other contexts, 57 58 these will be assessed and reported descrip-tively.”
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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