A tutorial on pilot studies: the what, why and how

Thabane, Lehana; Ma, Jinhui; Chu, Rong; Cheng, Ji; Ismaila, Afisi S; Rios, Lorena P.; Robson, Reid; Thabane, Marroon; Giangregorio, Lora; Goldsmith, Charles H.

doi:10.1186/1471-2288-10-1

Cited by 2,202 publications

(2,272 citation statements)

References 24 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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“…Although few pilot studies about feasibility of physical therapy in older adult have been found, the current literature shows the importance of this type of studies because they can contribute to avoid mistakes in the implementation of a RCT, especially when dealing with older adults. 27,28 With reference to the specific objectives of the pilot study, recruitment for the small sample in this pilot was achieved within the time frame. A larger trial would be necessary to recruit participants from other nursing homes to obtain a larger sample.…”

Section: Discussionmentioning

confidence: 99%

“…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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“…We used a pilot RCT design 186 to assess the likely benefits and harms of named nurse PC to allow inferences about the possible causal effects of our new intervention. The MRC framework 30 recommends RCTs early in the development and testing of complex interventions.…”

Section: Summary Of the Upbeat-uk Programmementioning

confidence: 99%

UPBEAT-UK: a programme of research into the relationship between coronary heart disease and depression in primary care patients

Tylee

Barley

Walters

et al. 2016

Programme Grants Appl Res

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BackgroundDepression is common in patients with coronary heart disease (CHD) but the relationship is uncertain. In the UK, general practitioners (GPs) have been remunerated for finding depression in CHD patients; however, it is unclear how to manage these patients.ObjectivesOur aim was to explore the relationship between CHD and depression in a GP population and to develop nurse-led personalised care (PC) for patients with CHD and depression.DesignThe UPBEAT-UK study consisted of four related studies. A cohort study of patients from CHD registers to explore the relationship between CHD and depression. A metasynthesis of relevant literature and two qualitative studies [patients’ perspectives and GP/practice nurse (PN) views on management of CHD and depression] helped develop an intervention. A pilot randomised controlled trial (RCT) of PC was conducted.SettingThirty-three GP surgeries in south London.ParticipantsAdult patients on GP CHD registers.InterventionsFrom the qualitative studies, we developed nurse-led PC, combining case management and self-management theory. Following biopsychosocial assessment, a PC plan was devised for each patient with chest pain and depressive symptoms. Nurses helped patients address their most important related problems. Use of existing resources was promoted. Nurse time was conserved through telephone follow-up.Main outcome measuresThe main outcome of the pilot study of our newly developed PC for people with depression and CHD was to assess the acceptability and feasibility of the intervention and to decide on the best outcome measures. Depression, measured by the Hospital Anxiety and Depression Scale – depression subscale, and chest pain, measured by the Rose angina questionnaire, were the main outcome measures for the feasibility and cohort studies. Cardiac outcomes in the cohort study included: attendance at rapid access chest pain clinics, stent insertion, bypass graft surgery, myocardial infarction and cardiovascular death. Service use and costs were measured and linked to quality-adjusted life-years (QALYs). Data for the pilot RCT were obtained by research assistants from patient interviews at baseline, 1, 6 and 12 months for the pilot RCT and at baseline and 6-monthly interviews for up to 36 months for the cohort study, using standard questionnaires.ResultsPersonalised care was acceptable to patients and proved feasible. The reporting of chest pain in the intervention group was half that of the control group at 6 months, and this reduction was maintained at 1 year. There was also a small improvement in self-efficacy measures in the intervention group at 12 months. Anxiety was more prevalent than depression in our CHD cohort over the 3 years. Nearly half of the cohort complained of chest pain at outset, with two-thirds of these being suggestive of angina. Baseline exertional chest pain (suggestive of angina), anxiety and depression were independent predictors of adverse cardiac outcome. Psychosocial factors predicted the continued reporting of exertional chest pain across the 3 years of follow-up. Costs were slightly lower for the PC group but QALYs were also lower. Neither difference was statistically significant.ConclusionsChest pain, anxiety, depression and social problems are common in patients on CHD registers in primary care and predict adverse cardiac outcomes. Together they pose a complex management problem for GPs and PNs. Our pilot trial of PC suggests a promising approach for treatment of these patients. Generalisation is limited because of the selection bias in recruitment of the practices and the subsequent participation rate of the CHD register patients, and the fact that the research took place in south London boroughs. Future work should explicitly explore methods for effective implementation of the intervention, including staff training needs and changes to practice.Trial registrationCurrent Controlled Trials ISRCTN21615909.FundingThis project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full inProgramme Grants for Applied Research; Vol. 4, No. 8. See the NIHR Journals Library website for further project information.

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A tutorial on pilot studies: the what, why and how

Cited by 2,202 publications

References 24 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

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

UPBEAT-UK: a programme of research into the relationship between coronary heart disease and depression in primary care patients

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