scholarly journals Views of healthcare professionals on recruiting to trials of psychosocial research: a qualitative study

2019 ◽  
Author(s):  
Trefor Aspden ◽  
Megan Armstrong ◽  
Marc Serfaty
Keyword(s):  
Health Care ◽  
Health Care Professionals ◽  
Healthcare Professionals ◽  
Controlled Trial ◽  
Psychosocial Interventions ◽  
Controlled Trials ◽  
Structured Interviews ◽  
Positive Health ◽  
Randomised Controlled ◽  
Views Of Healthcare Professionals

Abstract Background: Randomised controlled trials, and in particular those of psychosocial interventions, often fail to recruit to target, resulting in underpowered trials with poor generalisability of findings. The objectives of this study was to explore the views of healthcare professionals on recruiting to psychosocial research studies, and to explore their views on factors that may hinder or facilitate recruitment. Methods: We conducted 14 semi-structured interviews, with healthcare professionals who had been involved in recruitment into a randomised controlled trial of a talking therapy for depression in patients with advanced cancer. Interviews were transcribed and analysed using thematic analysis. Results: Six primary themes were identified, comprised of 15 subthemes. Attitudes towards research were largely positive. Health care professionals identified lack of time and narrow screening criteria as barriers to recruitment, and also noted the tendency to withhold participants from research for reasons other than eligibility (e.g., gatekeeping). The engagement of the study team with the clinical recruitment site, and the frequent presence of a researcher in clinics, were noted as facilitating recruitment. Conclusions: Healthcare professionals involved in recruiting to trials of psychosocial interventions hold generally positive views of psychosocial research, but report that constraints limit their ability to recruit. The findings from this study can inform how best to design trials, and in particular trials of psychosocial interventions, and train health care professionals for the study, to maximise recruitment. Trial registration: Controlled Trials ISRCTN07622709, registered 15 July 2011

scholarly journals Views of healthcare professionals on recruiting to a psychosocial randomised controlled trial: a qualitative study.

2019 ◽  
Author(s):  
Trefor Aspden ◽  
Megan Armstrong ◽  
Marc Serfaty
Keyword(s):  
Health Care ◽  
Randomised Controlled Trial ◽  
Health Care Professionals ◽  
Healthcare Professionals ◽  
Controlled Trial ◽  
Psychosocial Interventions ◽  
Controlled Trials ◽  
Positive Health ◽  
Randomised Controlled ◽  
Views Of Healthcare Professionals

Abstract Background: Randomised controlled trials, and in particular those of psychosocial interventions, often fail to recruit to target, resulting in underpowered trials with poor generalisability of findings. The objectives of this study were to explore the views of healthcare professionals on recruiting to psychosocial research studies, and to explore their views on factors that may hinder or facilitate recruitment. Methods: We conducted 14 semi-structured interviews, with healthcare professionals who had been involved in recruitment into a randomised controlled trial of a talking therapy for depression in patients with advanced cancer. Interviews were transcribed and analysed using thematic analysis. Results: Five primary themes were identified, comprised of 13 subthemes. Attitudes towards research were largely positive. Health care professionals identified lack of time and narrow screening criteria as barriers to recruitment, and also noted the tendency to withhold participants from research for reasons other than eligibility (e.g., gatekeeping). The engagement of the study team with the clinical recruitment site, and the frequent presence of a researcher in clinics, were noted as facilitating recruitment. Conclusions: Healthcare professionals involved in recruiting to trials of psychosocial interventions hold generally positive views of psychosocial research, but report that constraints limit their ability to recruit. The findings from this study can inform how best to design trials, and in particular trials of psychosocial interventions, and train health care professionals for the study, to maximise recruitment. Trial registration: Controlled Trials ISRCTN07622709, registered 15 July 2011

scholarly journals Views of healthcare professionals on recruiting to a psychosocial randomised controlled trial: a qualitative study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Trefor Aspden ◽  
Megan Armstrong ◽  
Marc Serfaty
Keyword(s):  
Health Care ◽  
Randomised Controlled Trial ◽  
Health Care Professionals ◽  
Healthcare Professionals ◽  
Controlled Trial ◽  
Psychosocial Interventions ◽  
Structured Interviews ◽  
Positive Health ◽  
Randomised Controlled ◽  
Views Of Healthcare Professionals

Abstract Background Randomised controlled trials, and in particular those of psychosocial interventions, often fail to recruit to target, resulting in underpowered trials with poor generalisability of findings. The objectives of this study were to explore the views of healthcare professionals on recruiting to psychosocial research studies, and to explore their views on factors that may hinder or facilitate recruitment. Methods We conducted 14 semi-structured interviews, with healthcare professionals who had been involved in recruitment into a randomised controlled trial of a talking therapy for depression in patients with advanced cancer. Interviews were transcribed and analysed using thematic analysis. Results Five primary themes were identified, comprised of 11 subthemes. Attitudes towards research were largely positive. Health care professionals identified lack of time and narrow screening criteria as barriers to recruitment, and also noted the tendency to withhold participants from research for reasons other than eligibility (e.g., gatekeeping). The engagement of the study team with the clinical recruitment site, and the frequent presence of a researcher in clinics, were noted as facilitating recruitment. Conclusions Healthcare professionals involved in recruiting to trials of psychosocial interventions hold generally positive views of psychosocial research. However, they report that constraints including space and time limit their ability to recruit, and express anxieties about approaching patients for trial recruitment in the palliative phase of their illness. The findings from this study can inform how best to design trials, and in particular trials of psychosocial interventions, and train health care professionals for the study, to maximise recruitment.

scholarly journals Reporting of “dialysis adequacy” as an outcome in randomised trials conducted in adults on haemodialysis: a systematic review

2018 ◽  
Author(s):  
Sanne Steyaert ◽  
Els Holvoet ◽  
Evi Nagler ◽  
Simon Malfait ◽  
Wim Van Biesen
Keyword(s):  
Systematic Review ◽  
Decision Making ◽  
Outcome Measures ◽  
Health Care Professionals ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Structured Interviews ◽  
Dialysis Adequacy ◽  
Registration Number ◽  
Randomised Controlled

ABSTRACTBackgroundClinical trials are most informative for evidence-based decision-making when they consistently measure and report outcomes of relevance to stakeholders, especially patients, clinicians, and policy makers. However, sometimes terminology used is interpreted differently by different stakeholders, which might lead to confusion during shared decision making. The construct dialysis adequacy is frequently used, suggesting it is an important outcome both for health care professionals as for patients.ObjectiveTo assess the scope and consistency of the construct dialysis adequacy as reported in randomised controlled trials in hemodialysis, and evaluate whether these align to the insights and understanding of this construct by patients.MethodsTo assess scope and consistency of dialysis adequacy by professionals, we performed a systematic review searching the Cochrane Central Register of Controlled Trials (CENTRAL) up to July 2017. We identified all randomised controlled trails (RCT) including patients on hemodialysis and reporting dialysis adequacy, adequacy or adequacy of dialysis and extracted and classified all reported outcomes. To explore interpretation and meaning of the construct of adequacy by patients, we conducted 10 semi-structured interviews with HD patients using thematic analysis. Belgian registration number B670201731001.FindingsFrom the 31 included trials, we extracted and classified 98 outcome measures defined by the authors as adequacy of dialysis, of which 94 (95%) were biochemical, 3 (3%) non-biochemical surrogate and 2 (2%) patient-relevant. The three most commonly reported measures were all biochemical. None of the studies defined adequacy of dialysis as a patient relevant outcome such as survival or quality of life.Patients had a substantially different understanding of the construct dialysis adequacy than the biochemical interpretation reported in the literature. Being alive, time spent while being on dialysis, fatigue and friendliness of staff were the most prominent themes that patients linked to the construct of dialysis adequacy.Conclusion Adequacy of dialysis as reported in the literature refers to biochemical outcome measures, most of which are not related with patient relevant outcomes. For patients, adequate dialysis is a dialysis that enables them to spend as much quality time in their life as possible.

scholarly journals Process evaluation of a randomised controlled trial of a diabetes prevention intervention in Dutch primary health care: the SLIMMER study

2016 ◽  
Vol 19 (16) ◽  
pp. 3027-3038 ◽  
Author(s):  
Ellen JI van Dongen ◽  
Geerke Duijzer ◽  
Sophia C Jansen ◽  
Josien ter Beek ◽  
Johanna M Huijg ◽  
...  
Keyword(s):  
Health Care ◽  
Primary Health Care ◽  
Process Evaluation ◽  
Health Care Professionals ◽  
Controlled Trial ◽  
Dietary Behaviour ◽  
Implementation Integrity ◽  
Primary Health ◽  
Randomised Controlled

AbstractObjectiveTo investigate (i) how the SLIMMER intervention was delivered and received in Dutch primary health care and (ii) how this could explain intervention effectiveness.DesignA randomised controlled trial was conducted and subjects were randomly allocated to the intervention (10-month combined dietary and physical activity intervention) or the control group. A process evaluation including quantitative and qualitative methods was conducted. Data on process indicators (recruitment, reach, dose received, acceptability, implementation integrity and applicability) were collected via semi-structured interviews with health-care professionals (n 45) and intervention participant questionnaires (n 155).SettingSLIMMER was implemented in Dutch primary health care in twenty-five general practices, eleven dietitians, nine physiotherapist practices and fifteen sports clubs.SubjectsSubjects at increased risk of developing type 2 diabetes were included.ResultsIt was possible to recruit the intended high-risk population (response rate 54 %) and the SLIMMER intervention was very well received by both participants and health-care professionals (mean acceptability rating of 82 and 80, respectively). The intervention programme was to a large extent implemented as planned and was applicable in Dutch primary health care. Higher dose received and participant acceptability were related to improved health outcomes and dietary behaviour, but not to physical activity behaviour.ConclusionsThe present study showed that it is feasible to implement a diabetes prevention intervention in Dutch primary health care. Higher dose received and participant acceptability were associated with improved health outcomes and dietary behaviour. Using an extensive process evaluation plan to gain insight into how an intervention is delivered and received is a valuable way of identifying intervention components that contribute to implementation integrity and effective prevention of type 2 diabetes in primary health care.

scholarly journals The feasibility of determining the effectiveness and cost-effectiveness of medication organisation devices compared with usual care for older people in a community setting: systematic review, stakeholder focus groups and feasibility randomised controlled trial

2016 ◽  
Vol 20 (50) ◽  
pp. 1-250 ◽  
Author(s):  
Debi Bhattacharya ◽  
Clare F Aldus ◽  
Garry Barton ◽  
Christine M Bond ◽  
Sathon Boonyaprapa ◽  
...  
Keyword(s):  
Systematic Review ◽  
Health Care ◽  
Cost Effectiveness ◽  
Health Outcomes ◽  
Focus Groups ◽  
Health Care Professionals ◽  
Controlled Trial ◽  
Clinical Effectiveness ◽  
Health Technology ◽  
Randomised Controlled

BackgroundMedication organisation devices (MODs) provide compartments for a patient’s medication to be organised into the days of the week and the recommended times the medication should be taken.AimTo define the optimal trial design for testing the clinical effectiveness and cost-effectiveness of MODs.DesignThe feasibility study comprised a systematic review and focus groups to inform a randomised controlled trial (RCT) design. The resulting features were tested on a small scale, using a 2 × 2 factorial design to compare MODs with usual packaging and to compare weekly with monthly supply. The study design was then evaluated.SettingPotential participants were identified by medical practices.ParticipantsAged over 75 years, prescribed at least three solid oral dosage form medications, unintentionally non-adherent and self-medicating. Participants were excluded if deemed by their health-care team to be unsuitable.InterventionsOne of three MODs widely used in routine clinical practice supplied either weekly or monthly.ObjectivesTo identify the most effective method of participant recruitment, to estimate the prevalence of intentional and unintentional non-adherence in an older population, to provide a point estimate of the effect size of MODs relative to usual care and to determine the feasibility and acceptability of trial participation.MethodsThe systematic review included MOD studies of any design reporting medication adherence, health and social outcomes, resource utilisation or dispensing or administration errors. Focus groups with patients, carers and health-care professionals supplemented the systematic review to inform the RCT design. The resulting design was implemented and then evaluated through questionnaires and group discussions with participants and health-care professionals involved in trial delivery.ResultsStudies on MODs are largely of poor quality. The relationship between adherence and health outcomes is unclear. Of the limited studies reporting health outcomes, some reported a positive relationship while some reported increased hospitalisations associated with MODs. The pre-trial focus groups endorsed the planned study design, but suggested a minimum recruitment age of 50–60 years. A total of 35.4% of patients completing the baseline questionnaire were excluded because they already used a MOD. Active recruitment yielded a higher consent rate, but passive recruitment was more cost-effective. The prevalence of intentional non-adherence was 24.7% [n = 71, 95% confidence interval (CI) 19.7% to 29.6%] of participants. Of the remaining 76 participants, 46.1% (95% CI 34.8% to 57.3%) were unintentionally non-adherent. There was no indication of a difference in adherence between the study arms. Participants reported a high level of satisfaction with the design. Five adverse/serious adverse events were identified in the MOD study arms and none was identified in the control arms. There was no discernible difference in health economic outcomes between the four study arms; the mean intervention cost was £20 per month greater for MOD monthly relative to usual supply monthly.ConclusionsMOD provision to unintentionally non-adherent older people may cause medication-related adverse events. The primary outcome for a definitive MOD trial should be health outcomes. Such a trial should recruit patients by postal invitation and recruit younger patients.Future workA study examining the association between MOD initiation and adverse effects is necessary and a strategy to safely introduce MODs should be explored. A definitive study testing the clinical effectiveness and cost-effectiveness of MODs is also required.Study registrationCurrent Controlled Trials ISRCTN 30626972 and UKCRN 12739.FundingThis project was funded by National Institute for Health Research (NIHR) Health Technology Assessment Programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 50. See the NIHR Journals Library website for further project information.

scholarly journals Community perspectives on randomisation and fairness in a cluster randomised controlled trial in Zambia

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Maureen Mupeta Kombe ◽  
Joseph Mumba Zulu ◽  
Charles Michelo ◽  
Ingvild F. Sandøy
Keyword(s):  
Randomised Controlled Trials ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Controlled Trials ◽  
Structured Interviews ◽  
Cluster Randomised ◽  
Research Initiative ◽  
Randomised Controlled ◽  
Rural Zambia ◽  
To Receive

Abstract Background One important ethical issue in randomised controlled trials (RCTs) is randomisation. Relatively little is known about how participating individuals and communities understand and perceive central aspects of randomisation such as equality, fairness, transparency and accountability in community-based trials. The aim of this study was to understand and explore study communities’ perspectives of the randomisation process in a cluster RCT in rural Zambia studying the effectiveness of different support packages for adolescent girls on early childbearing. Methods In this explorative study, in-depth semi-structured interviews were carried out in 2018 with 14 individuals who took part in the randomisation process of the Research Initiative to Support the Empowerment of Girls (RISE) project in 2016 and two traditional leaders. Two of the districts where the trial is implemented were purposively selected. Interviews were audio recorded and fully transcribed. Data were analysed by coding and describing emergent themes. Results The understanding of the randomisation process varied. Some respondents understood that randomisation was conducted for research purposes, but most of them did not. They had trouble distinguishing research and aid. Generally, respondents perceived the randomisation process as transparent and fair. However, people thought that there should not have been a “lottery” because they wanted all schools to receive equal or balanced benefits of the interventions. Conclusions Randomisation was misunderstood by most respondents. Perceived procedural fairness was easier to realize than substantive fairness. Researchers working on Cluster Randomised Controlled Trials (CRCTs) should consider carefully how to explain randomisation.

85 Exploring the Feasibility of the Adapted Lifestyle - Integrated Functional Exercise (ALIFE) Programme to Prevent Falls among Older Adults in Thailand

2019 ◽  
Vol 48 (Supplement_4) ◽  
pp. iv18-iv27
Author(s):  
Sasiporn Ounjaichon ◽  
Chris Todd ◽  
Emma Stanmore ◽  
Elisabeth Boulton
Keyword(s):  
Older Adults ◽  
Fall Prevention ◽  
Cultural Context ◽  
Healthcare Professionals ◽  
Controlled Trial ◽  
Exercise Programme ◽  
Community Dwelling ◽  
Structured Interviews ◽  
Functional Exercise ◽  
Randomised Controlled

Abstract Background Falls are the leading cause of injuries in older adults in Thailand. Exercise appears to be a strategy to reduce falls. There is a need to develop a fall prevention exercise programme to encourage participation and adherence. The adapted Lifestyle-integrated Functional Exercise (aLiFE) programme may be suitable by integrating exercise into daily routines as opposed to attending an exercise class. This study aimed to explore the acceptability and feasibility of the aLiFE programme in older Thai adults and identify if modifications are necessary for this population. Method To obtain older Thai adults' perspectives and stakeholders’ views, 40 community-dwelling older adults aged ≥ 60 years, in urban and rural locations in Thailand, and 14 stakeholders (e.g. healthcare professionals) working with older Thai adults were included. Qualitative methods were used to conduct focus groups and in-depth interviews with older adults, and semi-structured interviews with stakeholders. Thematic analyses using Framework Approach were conducted. Results Findings revealed positive views and identified four themes including: (a) individual factors, (b) perceptions of aLiFE, (c) recommendations for implementing aLiFE in Thailand, and (d) motivation. Older participants expressed interest in performing aLiFE in their daily activities, although some activities may need to be modified to fit the Thai cultural context. Stakeholders were concerned about how to motivate older Thai adults to adhere to aLiFE. Healthcare professionals and family members could play a major role to support older adults in uptake of aLiFE. Benefits (e.g. independence and fall prevention) may motivate older adults to engage in aLiFE. Clear and simple instructions were requested. Conclusion The aLiFE programme should be feasible and acceptable among older Thai adults. The aLiFE programme has been appropriately modified to be ‘Thai LiFE (TLiFE)’. A feasibility randomised controlled trial of the TLiFE programme has been conducted in older Thai adults.

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