The role and interpretation of pilot studies in clinical research

Leon, Andrew C.; Davis, Lori L.; Kraemer, Helena C.

doi:10.1016/j.jpsychires.2010.10.008

Cited by 1,338 publications

(1,125 citation statements)

References 11 publications

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“…The main purpose of the follow up was to determine whether the outcomes could be assessed, and complete data was obtained on those followed up. Following guidance for feasibility studies 31, 32, 62, 63, 64, no formal statistical testing for effectiveness was carried out. Inspection of the data (Table 2) shows that men in the intervention group reduced the frequency of their binge drinking (8 or more units in a session) by slightly more than men in the control group.…”

Section: Resultsmentioning

confidence: 99%

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Alcohol and disadvantaged men: A feasibility trial of an intervention delivered by mobile phone

Crombie

Irvine

Falconer

et al. 2017

Drug and Alcohol Review

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Introduction and AimsDisadvantaged men suffer substantial harm from heavy drinking. This feasibility study developed and evaluated the methods for a trial of a brief intervention delivered by text messages to disadvantaged men. It aimed to test the methods for recruitment and retention, to monitor engagement with the intervention and assess the overall acceptability of study methods.Design and MethodsDisadvantaged men aged 25–44 years who had ≥2 episodes of binge drinking (≥8 units in one session) in the preceding month were recruited. Two recruitment strategies were assessed: recruitment from general practice registers and by a community outreach strategy. Theoretically and empirically based text messages were tailored to the target group.ResultsThe study recruited 67 disadvantaged men at high risk of alcohol‐related harm, exceeding the target of 60. Evaluation showed that 95% of text messages were delivered, and the men engaged enthusiastically with the intervention. Retention at follow up was 96%. Outcomes were successfully measured on all men followed up. This provided data for the sample size calculation for the full trial. Post‐study evaluation showed high levels of satisfaction with the study.Discussion and ConclusionsThis study has shown that disadvantaged men can be recruited and follow‐up data obtained in an alcohol intervention study. The study methods were acceptable to the participants. The men recruited were at high risk of alcohol‐related harms. It also clarified ways in which the recruitment strategy, the baseline questionnaire and the intervention could be improved. The full trial is currently underway. [Crombie IK, Irvine L, Falconer DW, Williams B, Ricketts IW, Jones C, Humphris G, Norrie J, Slane P, Rice P. Alcohol and disadvantaged men: A feasibility trial of an intervention delivered by mobile phone. Drug Alcohol Rev 2017;36:468‐476]

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Section: Resultsmentioning

confidence: 99%

“…Following the guidance of methodologists 31, 62, 63, 64, this feasibility study did not attempt to estimate the effectiveness of the intervention. Feasibility studies are underpowered to detect intervention effects.…”

Section: Discussionmentioning

confidence: 99%

Alcohol and disadvantaged men: A feasibility trial of an intervention delivered by mobile phone

Crombie

Irvine

Falconer

et al. 2017

Drug and Alcohol Review

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“…Then, to convince the stakeholders that the intended project is worth supporting. On this point, Leon et al (2011) men tioned that one of the most important implementations and practices in conducting a pilot study is that investigators, grant reviewers, and other stakeholders need to be aware of all sides of the pilot studies from to the essential elements to the limitations. Reality, the present work strongly tend to agree that such implementations and practices are reasona ble and help business sector to reach goals with low costs in case the pilot or feasibility studies are done professionally.…”

Section: Pilot Studies In Business Sector: Implementations and Practicesmentioning

confidence: 99%

A Pilot Study: Vital Methodological Issues

Hazzi

Maldaon

2015

Business: Theory and Practice

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Abstract.A pilot study represents a vital step for conducting a full fledged study soundly. In fact, a well conducted pilot study can help the researchers to design a clear road map they can follow. Conducting a pilot study professionally, however, involves vital quantitative methodological issues (i.e., Back Translation, Missing Data, Normality, and Reliability) the researchers had better take into account when conducting the pilot study and before embarking the main one. Unfortunately, such issues are neglected in many researches as well as barely addressed together in a one work in research papers. From the literature and the experience, the present work aims to address the most recommended practices of such methodological issues providing at the same time the best practices for new researchers and scholars alike, with a view to reduce the loss of suffered by research com munity when such issues and practices remain unpublished together. Suggestions and thoughts were also demonstrated in this work for further researches. Finally, the importance of such research for business sector was also demonstrated in this work.

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“…In this context, a total of 44 participants were considered to be adequate for this purpose, as stated in some publications that concern the implementation of pilot studies. [25][26][27] Statistical Analysis Recruitment, participation, adherence rates, and percentage of participants randomized were presented descriptively. Descriptive statistics were also calculated to describe baseline data.…”

Section: Sample Size Calculationmentioning

confidence: 99%

Mobilization With Movement for Shoulder Dysfunction in Older Adults: A Pilot Trial

Lirio-Romero¹,

Torres-Lacomba

Montoro³

et al. 2015

Journal of Chiropractic Medicine

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Objective: The purpose of this study was to evaluate the feasibility of the methods proposed to conduct a full randomized clinical trial to assess the effectiveness of mobilization with movement on shoulder functionality in older adults with shoulder dysfunction. Methods: A pilot, randomized, single-blinded clinical trial was carried out with 44 older adults (83.9±8.2 years) with shoulder dysfunction in 3 nursing homes in Toledo, Spain. Participants were recruited through information sessions and were randomly allocated into 2 groups. The control group (n = 22) intervention consisted of a physical therapy standard protocol proposed by the Spanish Rheumatology Society. Techniques based on Mulligan's concepts of mobilization with movement were added to the standard protocol for the experimental group (n = 22) intervention. Interventions took place 3 times a week for 2 consecutive weeks and were performed by 2 experienced therapists. Main outcomes were recruitment rates, participation and adherence to interventions, assessment procedures, and the implementation of mobilization with movement. Clinical outcomes were shoulder functionality, active glenohumeral range of motion, and pain intensity. Data were collected at baseline, after each group intervention, and at 1 and 3 months after finishing interventions. Results: All the participants accepted to be randomized. Participation rates were 97.7% for the experimental group and 95.5% for the control group. The analysis of variance did not show any statistically significant difference between treatment groups for any of the variables (all P values for the group effect were greater than .36) or a change of the difference between groups over time (all P values for the time-treatment interactions were greater than .3).Conclusion: The research methods tested in this pilot study offer a suitable foundation to conduct a full clinical trial.

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The role and interpretation of pilot studies in clinical research

Cited by 1,338 publications

References 11 publications

Alcohol and disadvantaged men: A feasibility trial of an intervention delivered by mobile phone

Alcohol and disadvantaged men: A feasibility trial of an intervention delivered by mobile phone

A Pilot Study: Vital Methodological Issues

Mobilization With Movement for Shoulder Dysfunction in Older Adults: A Pilot Trial

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