Background: Despite an aging population, older adults are typically underrecruited in clinical tr... more Background: Despite an aging population, older adults are typically underrecruited in clinical trials, often because of the perceived burden associated with participation, particularly travel associated with clinic visits. Conducting a clinical trial remotely presents an opportunity to leverage mobile and wearable technologies to bring the research to the patient. However, the burden associated with shifting clinical research to a remote site requires exploration. While a remote trial may reduce patient burden, the extent to which this shifts burden on the other stakeholders needs to be investigated. Objective: The aim of this study was to explore the burden associated with a remote trial in a nursing home setting on both staff and residents. Methods: Using results from a grounded analysis of qualitative data, this study explored and characterized the burden associated with a remote trial conducted in a nursing home in Dublin, Ireland. A total of 11 residents were recruited to participate in this trial (mean age: 80 years; age range: 67-93 years). To support research activities, we also recruited 10 nursing home staff members, including health care assistants, an activities coordinator , and senior nurses. This study captured the lived experience of this remote trial among staff and residents and explored the burden associated with participation. At the end of the trial, a total of 6 residents and 8 members of staff participated in semistructured interviews (n=14). They reviewed clinical data generated by mobile and wearable devices and reflected upon their trial-related experiences. Results: Staff reported extensive burden in fulfilling their roles and responsibilities to support activities of the trial. Among staff, we found eight key characteristics of burden: (1) comprehension, (2) time, (3) communication, (4) emotional load, (5) cognitive load, (6) research engagement, (7) logistical burden, and (8) product accountability. Residents reported comparatively less burden. Among residents, we found only four key characteristics of burden: (1) comprehension, (2) adherence, (3) emotional load, and (4) personal space. Conclusions: A remote trial in a nursing home setting can minimize the burden on residents and enable inclusive participation. However, it arguably creates additional burden on staff, particularly where they have a role to play in locally supporting and maintaining technology as part of data collection. Future research should examine how to measure and minimize the burden associated with data collection in remote trials.
Background: Despite an aging population, older adults are typically underrecruited in clinical tr... more Background: Despite an aging population, older adults are typically underrecruited in clinical trials, often because of the perceived burden associated with participation, particularly travel associated with clinic visits. Conducting a clinical trial remotely presents an opportunity to leverage mobile and wearable technologies to bring the research to the patient. However, the burden associated with shifting clinical research to a remote site requires exploration. While a remote trial may reduce patient burden, the extent to which this shifts burden on the other stakeholders needs to be investigated. Objective: The aim of this study was to explore the burden associated with a remote trial in a nursing home setting on both staff and residents. Methods: Using results from a grounded analysis of qualitative data, this study explored and characterized the burden associated with a remote trial conducted in a nursing home in Dublin, Ireland. A total of 11 residents were recruited to participate in this trial (mean age: 80 years; age range: 67-93 years). To support research activities, we also recruited 10 nursing home staff members, including health care assistants, an activities coordinator , and senior nurses. This study captured the lived experience of this remote trial among staff and residents and explored the burden associated with participation. At the end of the trial, a total of 6 residents and 8 members of staff participated in semistructured interviews (n=14). They reviewed clinical data generated by mobile and wearable devices and reflected upon their trial-related experiences. Results: Staff reported extensive burden in fulfilling their roles and responsibilities to support activities of the trial. Among staff, we found eight key characteristics of burden: (1) comprehension, (2) time, (3) communication, (4) emotional load, (5) cognitive load, (6) research engagement, (7) logistical burden, and (8) product accountability. Residents reported comparatively less burden. Among residents, we found only four key characteristics of burden: (1) comprehension, (2) adherence, (3) emotional load, and (4) personal space. Conclusions: A remote trial in a nursing home setting can minimize the burden on residents and enable inclusive participation. However, it arguably creates additional burden on staff, particularly where they have a role to play in locally supporting and maintaining technology as part of data collection. Future research should examine how to measure and minimize the burden associated with data collection in remote trials.
International Journal of Psychiatry in Clinical Practice, 1998
Schizophrenia affects around 1% of the population but accounts for a much larger proportion of he... more Schizophrenia affects around 1% of the population but accounts for a much larger proportion of healthcare costs. New atypical antipsychotics are perceived as expensive because of higher drug costs, even though such drug costs account for only a small percentage of the total cost of care. However, if these agents reduce other types of treatment costs they could prove to be highly cost-effective. This paper presents a health economic model for the treatment of an acute episode of chronic schizophrenia and its subsequent control through maintenance treatment. Simulation experiments, using cost data reported for England, indicate that the most important treatment cost is care setting: treatments enabling patients to move from expensive inpatient and sheltered accommodation to less expensive settings represent the largest potential cost saving. Atypical antipsychotics with improved efficacy in negative symptoms and/or cognitive function may facilitate this and thus lead to substantial savings. Enhanced efficacy in positive symptoms, and improvements in compliance and relapse rates also have an influence on the cost of treating schizophrenia. Model predictions suggest that reported clinical profiles of atypical antipsychotics could lead to significant savings and large improvements in effectiveness over conventional therapy. Prospective studies are required to confirm these findings.
Abstract Our current regulatory framework identifies the steps needed to develop and validate cli... more Abstract Our current regulatory framework identifies the steps needed to develop and validate clinical endpoints. These approaches can be used to ensure that new digital endpoints derived using novel technologies can be implemented appropriately, and with sufficient supporting evidence, in clinical development programs. New digital endpoints from novel technologies provide opportunity to (i) measure constructs that cannot be measured feasibly using existing methods, (ii) measure objectively and with the potential of greater precision compared to some traditional methods, and (iii) measure more frequently and provide additional richness to the insights that can be gained compared to traditional measurement approaches. New technologies may also facilitate greater remote measurement which may enhance patient monitoring and make study participation more convenient. New technologies should be used to measure clinical endpoints not because it would be trendy or interesting to do so, but when they offer a viable approach to appropriately measure the endpoints of interest. Sponsors should select a “fit-for-purpose” technology with respect to the construct being studied, the protocol, and the study population, and use this evaluation to support their approach. Ensuring that the properties of clinical endpoints derived from novel technologies are well understood in reference to the target population is essential for their use in clinical development to support labeling claims and regulatory decision making. We understand enough to begin using these approaches where appropriate and to begin gaining acceptance for the clinical endpoints they can measure.
A357 handling platinum doublets (PD) as lumped or split nodes in an NMA of advNSCLC therapies. Me... more A357 handling platinum doublets (PD) as lumped or split nodes in an NMA of advNSCLC therapies. Methods: We conducted a systematic literature review in MEDLINE®, Embase, and published technology appraisal guidance from the National Institute for Health and Care Excellence to identify NMAs in advNSCLC that included PD. We extracted data on network structure, endpoints, relative effects, and rationale for lumping versus splitting. We evaluated the data against a theoretical framework of methodological and clinical considerations for lumping versus splitting. Results: From 136 hits, we identified 14 NMAs that included PD as comparators in an advN-SCLC network; seven lumped PD, five split PD, and two partially split PD. Among split networks, relative efficacy was similar across most PD; however, significant differences were evident in safety endpoints. The outcome-specific application of our framework compared the magnitude and direction of bias introduced by lumping certain PD against the changes in network structure imposed by splitting. Our framework highlighted the potential to introduce exchangeable effects for certain PD as an intermediate between lumping and splitting, obviating certain challenges of splitting while avoiding the strong lumping assumption. ConClusions: Carefully defining NMA treatment nodes is a critical step toward producing methodologically rigorous and clinically meaningful results. This exploration applies to a broad range of researchers faced with the decision of whether to lump or split nodes. PRM3 Causes of Death statistiCs unDeRestiMate the BuRDen of heaD anD neCk (h&n) CanCeRs: a nationwiDe stuDy fRoM fRanCe in 2008-2012
Journal of Medical Internet Research, Jun 19, 2018
Background: Despite an aging population, older adults are typically underrecruited in clinical tr... more Background: Despite an aging population, older adults are typically underrecruited in clinical trials, often because of the perceived burden associated with participation, particularly travel associated with clinic visits. Conducting a clinical trial remotely presents an opportunity to leverage mobile and wearable technologies to bring the research to the patient. However, the burden associated with shifting clinical research to a remote site requires exploration. While a remote trial may reduce patient burden, the extent to which this shifts burden on the other stakeholders needs to be investigated. Objective: The aim of this study was to explore the burden associated with a remote trial in a nursing home setting on both staff and residents. Methods: Using results from a grounded analysis of qualitative data, this study explored and characterized the burden associated with a remote trial conducted in a nursing home in Dublin, Ireland. A total of 11 residents were recruited to participate in this trial (mean age: 80 years; age range: 67-93 years). To support research activities, we also recruited 10 nursing home staff members, including health care assistants, an activities coordinator , and senior nurses. This study captured the lived experience of this remote trial among staff and residents and explored the burden associated with participation. At the end of the trial, a total of 6 residents and 8 members of staff participated in semistructured interviews (n=14). They reviewed clinical data generated by mobile and wearable devices and reflected upon their trial-related experiences. Results: Staff reported extensive burden in fulfilling their roles and responsibilities to support activities of the trial. Among staff, we found eight key characteristics of burden: (1) comprehension, (2) time, (3) communication, (4) emotional load, (5) cognitive load, (6) research engagement, (7) logistical burden, and (8) product accountability. Residents reported comparatively less burden. Among residents, we found only four key characteristics of burden: (1) comprehension, (2) adherence, (3) emotional load, and (4) personal space. Conclusions: A remote trial in a nursing home setting can minimize the burden on residents and enable inclusive participation. However, it arguably creates additional burden on staff, particularly where they have a role to play in locally supporting and maintaining technology as part of data collection. Future research should examine how to measure and minimize the burden associated with data collection in remote trials.
BACKGROUND: Sedentary behaviour (SB) is an important risk factor for a number of chronic diseases... more BACKGROUND: Sedentary behaviour (SB) is an important risk factor for a number of chronic diseases. Although gaps remain in our knowledge of the elements of SB most associated with reduced health outcomes, measuring SB is important, especially in less active patient populations where treatment-related changes may be seen first in changes in SB. METHODS: We review current published work in the measurement of SB to make recommendations for SB measurement in clinical studies. RESULTS: To help move our understanding of the area forward, we propose a set of derived measures of SB that can be easily understood and interpreted. CONCLUSION: Although there is more work required to determine and validate the most clinically relevant and sensitive measures of SB, there is enough understanding of how to measure SB to enable its inclusion in study protocols.
Applications utilising 3D Camera technologies for the measurement of health outcomes in the healt... more Applications utilising 3D Camera technologies for the measurement of health outcomes in the health and wellness sector continues to expand. The Intel® RealSense™ is one of the leading 3D depth sensing cameras currently available on the market and aligns itself for use in many applications, including robotics, automation, and medical systems. One of the most prominent areas is the production of interactive solutions for rehabilitation which includes gait analysis and facial tracking. Advancements in depth camera technology has resulted in a noticeable increase in the integration of these technologies into portable platforms, suggesting significant future potential for pervasive in-clinic and field based health assessment solutions. This paper reviews the Intel RealSense technology's technical capabilities and discusses its application to clinical research and includes examples where the Intel RealSense camera range has been used for the measurement of health outcomes. This review supports the use of the technology to develop robust, objective movement and mobility-based endpoints to enable accurate tracking of the effects of treatment interventions in clinical trials.
and log-odds ratios, calculated from the incidence data of each individual trial, were determined... more and log-odds ratios, calculated from the incidence data of each individual trial, were determined and A number of prospective randomized comparator combined using a fixed-effects meta-analysis apstudies have suggested that there is a reduction in proach. Patients who received maintenance of anpost-operative nausea and vomiting following mainaesthesia with propofol had a significantly lower tenance of anaesthesia with propofol compared with incidence of post-operative nausea and vomiting in inhalational agents. We analysed these studies in more comparison with inhalational agents regardless of indetail by examining the effects of induction agent, duction agent, choice of inhalation agent, presence/ choice of inhalation agent, presence/absence of niabsence of nitrous oxide, age of patient or use of trous oxide, age of patient or use of opiate on the opiate. incidence of emesis. A search of the Zeneca database MEDLEY was undertaken and prospective randomized
Journal of Comparative Effectiveness Research, Mar 1, 2020
We undertook qualitative research to understand more about older people and their interactions wi... more We undertook qualitative research to understand more about older people and their interactions with technology, specifically to evidence the question "can older people (seniors) manage electronic patient-reported outcomes solutions in clinical trials?". Methods: We undertook qualitative research interviews with older people and investigated the findings. Results: 7 of the 10 participants had a smartphone and 3 out of 10 had a feature phone (a mobile phone with buttons and no touchscreen). There was a shift from smartphone use by the younger participants to feature phone use by the oldest participants. Conclusion: The younger group of older individuals had similar experiences and attitudes toward touchscreen devices as the rest of the population. While the older participants expressed some reluctance toward unfamiliar technology, all participants were using technology and accepting of it.
This article presents a review of the research literature to identify the methodology used and ou... more This article presents a review of the research literature to identify the methodology used and outcome measures derived in the use of accelerometers to measure free-living activity in patients with COPD. Using this and existing empirical validity evidence we further identify standards for use, and recommended clinical outcome measures from continuous accelerometer data to describe pertinent measures of sedentary behaviour and physical activity in this and similar patient populations. We provide measures of the strength of evidence to support our recommendations and identify areas requiring continued research. Our findings support the use of accelerometry in clinical trials to understand and measure treatment-related changes in free-living physical activity and sedentary behaviour in patient populations with limited activity.
... 213 Breffni Martin 11 Future Developments and Applications: Emerging Technologies and New App... more ... 213 Breffni Martin 11 Future Developments and Applications: Emerging Technologies and New Approaches to Patients 237 Brian Tiplady and ... objects, or perform other tasks that reveal the quantitative capabilities of human sensory physiological mechanisms (Rosenblith, 1961 ...
BACKGROUND Patients’ informed consent to participate is fundamental to ethical clinical research.... more BACKGROUND Patients’ informed consent to participate is fundamental to ethical clinical research. Giving informed consent means agreeing to take part in the trial and having understood what is involved, including the risks and benefits of participation. Flawed informed consent processes, including missing dates and signatures, are common regulatory audit findings. Electronic consent (eConsent) uses digital technologies to enable the consenting process. It aims to improve participant comprehension and engagement with study information, and to address data quality concerns. OBJECTIVE This systematic literature review aimed to assess the effectiveness of eConsent in terms of patient comprehension, acceptability, usability, and study enrollment and retention rates, as well as effects on time patients took to perform the consenting process (“cycle time”) and on site workload, in comparison with traditional, paper-based consenting. METHODS The systematic review was conducted and reported in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. OVID Embase and OVID Medline were systematically searched for publications reporting original, comparative data on the effectiveness of eConsent in terms of patient comprehension, acceptability, usability, enrollment and retention rates, cycle time, and site workload. The methodological validity of studies that compared outcomes for comprehension, acceptability, and usability across paper consent and eConsent was assessed. Study methodologies were categorized as “high” if comprehensive assessments, such as established instruments, were used. RESULTS A total of 37 publications describing 35 studies (13,281 participants in total) were included. All studies comparing eConsenting and paper-based consenting for comprehension (20 studies [10 with “high” validity]), acceptability (8 studies [1 with “high” validity]), and usability (5 studies [1 with “high” validity]) reported either significantly better results with eConsent, better results but without significance testing, or no significant differences in overall results. No study reported better results with paper than eConsent. Among “high” validity studies, six studies on comprehension reported significantly better understanding for at least some concepts, the study on acceptability reported statistically significant higher satisfaction scores, and the study on usability reported statistically significant higher usability scores with eConsent than paper (all P<.05). Cycle times were increased with eConsent, potentially reflecting greater patient engagement with content. Data on enrollment and retention were limited. Comparative data from site staff and other study researchers indicated the potential for reduced workload and lower administrative burden with eConsent. CONCLUSIONS This systematic review showed that, compared with patients using paper-based consenting, patients using eConsent had a better understanding of the clinical trial information, showed greater engagement with content, and rated the consenting process as more acceptable and usable. eConsent solutions thus have the potential to enhance understanding, acceptability, and usability of the consenting process while inherently being able to address data quality concerns, including those related to flawed consenting processes. CLINICALTRIAL
Background: Despite an aging population, older adults are typically underrecruited in clinical tr... more Background: Despite an aging population, older adults are typically underrecruited in clinical trials, often because of the perceived burden associated with participation, particularly travel associated with clinic visits. Conducting a clinical trial remotely presents an opportunity to leverage mobile and wearable technologies to bring the research to the patient. However, the burden associated with shifting clinical research to a remote site requires exploration. While a remote trial may reduce patient burden, the extent to which this shifts burden on the other stakeholders needs to be investigated. Objective: The aim of this study was to explore the burden associated with a remote trial in a nursing home setting on both staff and residents. Methods: Using results from a grounded analysis of qualitative data, this study explored and characterized the burden associated with a remote trial conducted in a nursing home in Dublin, Ireland. A total of 11 residents were recruited to participate in this trial (mean age: 80 years; age range: 67-93 years). To support research activities, we also recruited 10 nursing home staff members, including health care assistants, an activities coordinator , and senior nurses. This study captured the lived experience of this remote trial among staff and residents and explored the burden associated with participation. At the end of the trial, a total of 6 residents and 8 members of staff participated in semistructured interviews (n=14). They reviewed clinical data generated by mobile and wearable devices and reflected upon their trial-related experiences. Results: Staff reported extensive burden in fulfilling their roles and responsibilities to support activities of the trial. Among staff, we found eight key characteristics of burden: (1) comprehension, (2) time, (3) communication, (4) emotional load, (5) cognitive load, (6) research engagement, (7) logistical burden, and (8) product accountability. Residents reported comparatively less burden. Among residents, we found only four key characteristics of burden: (1) comprehension, (2) adherence, (3) emotional load, and (4) personal space. Conclusions: A remote trial in a nursing home setting can minimize the burden on residents and enable inclusive participation. However, it arguably creates additional burden on staff, particularly where they have a role to play in locally supporting and maintaining technology as part of data collection. Future research should examine how to measure and minimize the burden associated with data collection in remote trials.
Background: Despite an aging population, older adults are typically underrecruited in clinical tr... more Background: Despite an aging population, older adults are typically underrecruited in clinical trials, often because of the perceived burden associated with participation, particularly travel associated with clinic visits. Conducting a clinical trial remotely presents an opportunity to leverage mobile and wearable technologies to bring the research to the patient. However, the burden associated with shifting clinical research to a remote site requires exploration. While a remote trial may reduce patient burden, the extent to which this shifts burden on the other stakeholders needs to be investigated. Objective: The aim of this study was to explore the burden associated with a remote trial in a nursing home setting on both staff and residents. Methods: Using results from a grounded analysis of qualitative data, this study explored and characterized the burden associated with a remote trial conducted in a nursing home in Dublin, Ireland. A total of 11 residents were recruited to participate in this trial (mean age: 80 years; age range: 67-93 years). To support research activities, we also recruited 10 nursing home staff members, including health care assistants, an activities coordinator , and senior nurses. This study captured the lived experience of this remote trial among staff and residents and explored the burden associated with participation. At the end of the trial, a total of 6 residents and 8 members of staff participated in semistructured interviews (n=14). They reviewed clinical data generated by mobile and wearable devices and reflected upon their trial-related experiences. Results: Staff reported extensive burden in fulfilling their roles and responsibilities to support activities of the trial. Among staff, we found eight key characteristics of burden: (1) comprehension, (2) time, (3) communication, (4) emotional load, (5) cognitive load, (6) research engagement, (7) logistical burden, and (8) product accountability. Residents reported comparatively less burden. Among residents, we found only four key characteristics of burden: (1) comprehension, (2) adherence, (3) emotional load, and (4) personal space. Conclusions: A remote trial in a nursing home setting can minimize the burden on residents and enable inclusive participation. However, it arguably creates additional burden on staff, particularly where they have a role to play in locally supporting and maintaining technology as part of data collection. Future research should examine how to measure and minimize the burden associated with data collection in remote trials.
International Journal of Psychiatry in Clinical Practice, 1998
Schizophrenia affects around 1% of the population but accounts for a much larger proportion of he... more Schizophrenia affects around 1% of the population but accounts for a much larger proportion of healthcare costs. New atypical antipsychotics are perceived as expensive because of higher drug costs, even though such drug costs account for only a small percentage of the total cost of care. However, if these agents reduce other types of treatment costs they could prove to be highly cost-effective. This paper presents a health economic model for the treatment of an acute episode of chronic schizophrenia and its subsequent control through maintenance treatment. Simulation experiments, using cost data reported for England, indicate that the most important treatment cost is care setting: treatments enabling patients to move from expensive inpatient and sheltered accommodation to less expensive settings represent the largest potential cost saving. Atypical antipsychotics with improved efficacy in negative symptoms and/or cognitive function may facilitate this and thus lead to substantial savings. Enhanced efficacy in positive symptoms, and improvements in compliance and relapse rates also have an influence on the cost of treating schizophrenia. Model predictions suggest that reported clinical profiles of atypical antipsychotics could lead to significant savings and large improvements in effectiveness over conventional therapy. Prospective studies are required to confirm these findings.
Abstract Our current regulatory framework identifies the steps needed to develop and validate cli... more Abstract Our current regulatory framework identifies the steps needed to develop and validate clinical endpoints. These approaches can be used to ensure that new digital endpoints derived using novel technologies can be implemented appropriately, and with sufficient supporting evidence, in clinical development programs. New digital endpoints from novel technologies provide opportunity to (i) measure constructs that cannot be measured feasibly using existing methods, (ii) measure objectively and with the potential of greater precision compared to some traditional methods, and (iii) measure more frequently and provide additional richness to the insights that can be gained compared to traditional measurement approaches. New technologies may also facilitate greater remote measurement which may enhance patient monitoring and make study participation more convenient. New technologies should be used to measure clinical endpoints not because it would be trendy or interesting to do so, but when they offer a viable approach to appropriately measure the endpoints of interest. Sponsors should select a “fit-for-purpose” technology with respect to the construct being studied, the protocol, and the study population, and use this evaluation to support their approach. Ensuring that the properties of clinical endpoints derived from novel technologies are well understood in reference to the target population is essential for their use in clinical development to support labeling claims and regulatory decision making. We understand enough to begin using these approaches where appropriate and to begin gaining acceptance for the clinical endpoints they can measure.
A357 handling platinum doublets (PD) as lumped or split nodes in an NMA of advNSCLC therapies. Me... more A357 handling platinum doublets (PD) as lumped or split nodes in an NMA of advNSCLC therapies. Methods: We conducted a systematic literature review in MEDLINE®, Embase, and published technology appraisal guidance from the National Institute for Health and Care Excellence to identify NMAs in advNSCLC that included PD. We extracted data on network structure, endpoints, relative effects, and rationale for lumping versus splitting. We evaluated the data against a theoretical framework of methodological and clinical considerations for lumping versus splitting. Results: From 136 hits, we identified 14 NMAs that included PD as comparators in an advN-SCLC network; seven lumped PD, five split PD, and two partially split PD. Among split networks, relative efficacy was similar across most PD; however, significant differences were evident in safety endpoints. The outcome-specific application of our framework compared the magnitude and direction of bias introduced by lumping certain PD against the changes in network structure imposed by splitting. Our framework highlighted the potential to introduce exchangeable effects for certain PD as an intermediate between lumping and splitting, obviating certain challenges of splitting while avoiding the strong lumping assumption. ConClusions: Carefully defining NMA treatment nodes is a critical step toward producing methodologically rigorous and clinically meaningful results. This exploration applies to a broad range of researchers faced with the decision of whether to lump or split nodes. PRM3 Causes of Death statistiCs unDeRestiMate the BuRDen of heaD anD neCk (h&n) CanCeRs: a nationwiDe stuDy fRoM fRanCe in 2008-2012
Journal of Medical Internet Research, Jun 19, 2018
Background: Despite an aging population, older adults are typically underrecruited in clinical tr... more Background: Despite an aging population, older adults are typically underrecruited in clinical trials, often because of the perceived burden associated with participation, particularly travel associated with clinic visits. Conducting a clinical trial remotely presents an opportunity to leverage mobile and wearable technologies to bring the research to the patient. However, the burden associated with shifting clinical research to a remote site requires exploration. While a remote trial may reduce patient burden, the extent to which this shifts burden on the other stakeholders needs to be investigated. Objective: The aim of this study was to explore the burden associated with a remote trial in a nursing home setting on both staff and residents. Methods: Using results from a grounded analysis of qualitative data, this study explored and characterized the burden associated with a remote trial conducted in a nursing home in Dublin, Ireland. A total of 11 residents were recruited to participate in this trial (mean age: 80 years; age range: 67-93 years). To support research activities, we also recruited 10 nursing home staff members, including health care assistants, an activities coordinator , and senior nurses. This study captured the lived experience of this remote trial among staff and residents and explored the burden associated with participation. At the end of the trial, a total of 6 residents and 8 members of staff participated in semistructured interviews (n=14). They reviewed clinical data generated by mobile and wearable devices and reflected upon their trial-related experiences. Results: Staff reported extensive burden in fulfilling their roles and responsibilities to support activities of the trial. Among staff, we found eight key characteristics of burden: (1) comprehension, (2) time, (3) communication, (4) emotional load, (5) cognitive load, (6) research engagement, (7) logistical burden, and (8) product accountability. Residents reported comparatively less burden. Among residents, we found only four key characteristics of burden: (1) comprehension, (2) adherence, (3) emotional load, and (4) personal space. Conclusions: A remote trial in a nursing home setting can minimize the burden on residents and enable inclusive participation. However, it arguably creates additional burden on staff, particularly where they have a role to play in locally supporting and maintaining technology as part of data collection. Future research should examine how to measure and minimize the burden associated with data collection in remote trials.
BACKGROUND: Sedentary behaviour (SB) is an important risk factor for a number of chronic diseases... more BACKGROUND: Sedentary behaviour (SB) is an important risk factor for a number of chronic diseases. Although gaps remain in our knowledge of the elements of SB most associated with reduced health outcomes, measuring SB is important, especially in less active patient populations where treatment-related changes may be seen first in changes in SB. METHODS: We review current published work in the measurement of SB to make recommendations for SB measurement in clinical studies. RESULTS: To help move our understanding of the area forward, we propose a set of derived measures of SB that can be easily understood and interpreted. CONCLUSION: Although there is more work required to determine and validate the most clinically relevant and sensitive measures of SB, there is enough understanding of how to measure SB to enable its inclusion in study protocols.
Applications utilising 3D Camera technologies for the measurement of health outcomes in the healt... more Applications utilising 3D Camera technologies for the measurement of health outcomes in the health and wellness sector continues to expand. The Intel® RealSense™ is one of the leading 3D depth sensing cameras currently available on the market and aligns itself for use in many applications, including robotics, automation, and medical systems. One of the most prominent areas is the production of interactive solutions for rehabilitation which includes gait analysis and facial tracking. Advancements in depth camera technology has resulted in a noticeable increase in the integration of these technologies into portable platforms, suggesting significant future potential for pervasive in-clinic and field based health assessment solutions. This paper reviews the Intel RealSense technology's technical capabilities and discusses its application to clinical research and includes examples where the Intel RealSense camera range has been used for the measurement of health outcomes. This review supports the use of the technology to develop robust, objective movement and mobility-based endpoints to enable accurate tracking of the effects of treatment interventions in clinical trials.
and log-odds ratios, calculated from the incidence data of each individual trial, were determined... more and log-odds ratios, calculated from the incidence data of each individual trial, were determined and A number of prospective randomized comparator combined using a fixed-effects meta-analysis apstudies have suggested that there is a reduction in proach. Patients who received maintenance of anpost-operative nausea and vomiting following mainaesthesia with propofol had a significantly lower tenance of anaesthesia with propofol compared with incidence of post-operative nausea and vomiting in inhalational agents. We analysed these studies in more comparison with inhalational agents regardless of indetail by examining the effects of induction agent, duction agent, choice of inhalation agent, presence/ choice of inhalation agent, presence/absence of niabsence of nitrous oxide, age of patient or use of trous oxide, age of patient or use of opiate on the opiate. incidence of emesis. A search of the Zeneca database MEDLEY was undertaken and prospective randomized
Journal of Comparative Effectiveness Research, Mar 1, 2020
We undertook qualitative research to understand more about older people and their interactions wi... more We undertook qualitative research to understand more about older people and their interactions with technology, specifically to evidence the question "can older people (seniors) manage electronic patient-reported outcomes solutions in clinical trials?". Methods: We undertook qualitative research interviews with older people and investigated the findings. Results: 7 of the 10 participants had a smartphone and 3 out of 10 had a feature phone (a mobile phone with buttons and no touchscreen). There was a shift from smartphone use by the younger participants to feature phone use by the oldest participants. Conclusion: The younger group of older individuals had similar experiences and attitudes toward touchscreen devices as the rest of the population. While the older participants expressed some reluctance toward unfamiliar technology, all participants were using technology and accepting of it.
This article presents a review of the research literature to identify the methodology used and ou... more This article presents a review of the research literature to identify the methodology used and outcome measures derived in the use of accelerometers to measure free-living activity in patients with COPD. Using this and existing empirical validity evidence we further identify standards for use, and recommended clinical outcome measures from continuous accelerometer data to describe pertinent measures of sedentary behaviour and physical activity in this and similar patient populations. We provide measures of the strength of evidence to support our recommendations and identify areas requiring continued research. Our findings support the use of accelerometry in clinical trials to understand and measure treatment-related changes in free-living physical activity and sedentary behaviour in patient populations with limited activity.
... 213 Breffni Martin 11 Future Developments and Applications: Emerging Technologies and New App... more ... 213 Breffni Martin 11 Future Developments and Applications: Emerging Technologies and New Approaches to Patients 237 Brian Tiplady and ... objects, or perform other tasks that reveal the quantitative capabilities of human sensory physiological mechanisms (Rosenblith, 1961 ...
BACKGROUND Patients’ informed consent to participate is fundamental to ethical clinical research.... more BACKGROUND Patients’ informed consent to participate is fundamental to ethical clinical research. Giving informed consent means agreeing to take part in the trial and having understood what is involved, including the risks and benefits of participation. Flawed informed consent processes, including missing dates and signatures, are common regulatory audit findings. Electronic consent (eConsent) uses digital technologies to enable the consenting process. It aims to improve participant comprehension and engagement with study information, and to address data quality concerns. OBJECTIVE This systematic literature review aimed to assess the effectiveness of eConsent in terms of patient comprehension, acceptability, usability, and study enrollment and retention rates, as well as effects on time patients took to perform the consenting process (“cycle time”) and on site workload, in comparison with traditional, paper-based consenting. METHODS The systematic review was conducted and reported in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. OVID Embase and OVID Medline were systematically searched for publications reporting original, comparative data on the effectiveness of eConsent in terms of patient comprehension, acceptability, usability, enrollment and retention rates, cycle time, and site workload. The methodological validity of studies that compared outcomes for comprehension, acceptability, and usability across paper consent and eConsent was assessed. Study methodologies were categorized as “high” if comprehensive assessments, such as established instruments, were used. RESULTS A total of 37 publications describing 35 studies (13,281 participants in total) were included. All studies comparing eConsenting and paper-based consenting for comprehension (20 studies [10 with “high” validity]), acceptability (8 studies [1 with “high” validity]), and usability (5 studies [1 with “high” validity]) reported either significantly better results with eConsent, better results but without significance testing, or no significant differences in overall results. No study reported better results with paper than eConsent. Among “high” validity studies, six studies on comprehension reported significantly better understanding for at least some concepts, the study on acceptability reported statistically significant higher satisfaction scores, and the study on usability reported statistically significant higher usability scores with eConsent than paper (all P<.05). Cycle times were increased with eConsent, potentially reflecting greater patient engagement with content. Data on enrollment and retention were limited. Comparative data from site staff and other study researchers indicated the potential for reduced workload and lower administrative burden with eConsent. CONCLUSIONS This systematic review showed that, compared with patients using paper-based consenting, patients using eConsent had a better understanding of the clinical trial information, showed greater engagement with content, and rated the consenting process as more acceptable and usable. eConsent solutions thus have the potential to enhance understanding, acceptability, and usability of the consenting process while inherently being able to address data quality concerns, including those related to flawed consenting processes. CLINICALTRIAL
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Papers by Bill Byrom