Use of a values inventory as a discussion aid about end-of-life care: A pilot randomized controlled trial

2015 ◽  
Vol 14 (4) ◽  
pp. 330-340 ◽  
Author(s):  
Shailaja Menon ◽  
Laurence B. McCullough ◽  
Rebecca J. Beyth ◽  
Marvella E. Ford ◽  
Donna Espadas ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
End Of Life ◽  
Medical Center ◽  
Controlled Trial ◽  
Intervention Group ◽  
Outpatient Setting ◽  
Control Group ◽  
Randomized Controlled ◽  
Eol Care ◽  
Pilot Randomized Controlled Trial

AbstractObjective:We examined the utility of a brief values inventory as a discussion aid to elicit patients' values and goals for end-of-life (EoL) care during audiotaped outpatient physician–patient encounters.Method:Participants were seriously ill male outpatients (n = 120) at a large urban Veterans Affairs medical center. We conducted a pilot randomized controlled trial, randomizing 60 patients to either the intervention (with the values inventory) or usual care. We used descriptive statistics and qualitative methods to analyze the data. We coded any EoL discussions and recorded the length of such discussions.Results:A total of 8 patients (13%) in the control group and 13 (23%) in the intervention group had EoL discussions with a physician (p = 0.77). All EoL discussions in the control group were initiated by the physician, compared with only five (38%) in the intervention group. Because most EoL discussions took place toward the end of the encounter, discussions were usually brief.Significance of results:The outpatient setting has been promoted as a better place for discussing EoL care than a hospital during an acute hospitalization for a chronic serious illness. However, the low effectiveness of our intervention calls into question the feasibility of discussing EoL care during a single outpatient visit. Allowing extra time or an extra visit for EoL discussions might increase the efficacy of advance care planning.

scholarly journals Medication Adherence Support of an In-home Electronic Medication Dispensing System for Individuals living with Chronic Conditions: A Pilot Randomized Controlled Trial

2021 ◽  
Author(s):  
Mubashir Arain ◽  
Armghan Ahmad ◽  
Venus Chiu ◽  
Lorena Kembel
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Chronic Conditions ◽  
Controlled Trial ◽  
Medication Management ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Abstract Background: Medication adherence is challenging for older adults due to factors such as the number of medications, dosing schedule, and the duration of drug therapy. The objective of this study was to examine the effectiveness of an in-home electronic medication dispensing system (MDS) on improving medication adherence and health perception in older adults with chronic conditions. Methods: A pilot Randomized Controlled Trial (RCT) was conducted using a two-arm parallel assignment model. The intervention group used an MDS as their medication management method. The control group continued to use their current methods of medication management. Block randomization was used to assign participants into the intervention or control group. The inclusion criteria included 1) English speaking 2) age 50 and over 3) diagnosed with one or more chronic condition(s) 4) currently taking five or more oral medications 5) City of Calgary resident. Participants were recruited from a primary care clinic in Alberta, Canada. The study was open label where knowledge about group assigned to participants after randomization was not withheld. Medication adherence was captured over a continuous, six-month period and analyzed using Intention-to-Treat (ITT) analysis. Results: A total of 91 participants were assessed for eligibility and 50 were randomized into the two groups. The number of participants analyzed for ITT was 23 and 25 in the intervention and control group, respectively. Most of the demographic characteristics were comparable in the two groups except mean age of the intervention group, which was higher compared to the control group (63.96±7.86 versus 59.52±5.93, p-value=0.03). The average recorded adherence over 26 weeks was significantly higher in the intervention group than the control group (98.35%±2.15% versus 91.17%±9.76%, p<0.01). The self-rated medication adherence in the intervention group also showed a significant increase from baseline to 6-month (7.63±1.63 versus 9.13±0.81, p<0.01). The control group showed a non-significant increase (7.20±1.74 versus 8.27±2.09, p=0.07). Conclusion: MDS can be an effective, long-term solution to medication non-adherence in older adults experiencing chronic conditions and taking multiple medications. The technology induces better consistency and improvement in medication taking behaviour than simple, non-technological intervention. Trial Registration: Registered with ClinicalTrials.gov on April 09, 2020 with identifier NCT04339296.

scholarly journals Differential Diagnosis Assessment in Ambulatory Care With an Automated Medical History–Taking Device: Pilot Randomized Controlled Trial

10.2196/14044 ◽  
2019 ◽  
Vol 7 (4) ◽  
pp. e14044 ◽  
Author(s):  
Adrien Jean-Pierre Schwitzguebel ◽  
Clarisse Jeckelmann ◽  
Roberto Gavinio ◽  
Cécile Levallois ◽  
Charles Benaïm ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Differential Diagnosis ◽  
Controlled Trial ◽  
Intervention Group ◽  
Differential Diagnoses ◽  
Control Group ◽  
History Taking ◽  
Randomized Controlled ◽  
Diagnosis Accuracy ◽  
Pilot Randomized Controlled Trial

Background Automated medical history–taking devices (AMHTDs) are emerging tools with the potential to increase the quality of medical consultations by providing physicians with an exhaustive, high-quality, standardized anamnesis and differential diagnosis. Objective This study aimed to assess the effectiveness of an AMHTD to obtain an accurate differential diagnosis in an outpatient service. Methods We conducted a pilot randomized controlled trial involving 59 patients presenting to an emergency outpatient unit and suffering from various conditions affecting the limbs, the back, and the chest wall. Resident physicians were randomized into 2 groups, one assisted by the AMHTD and one without access to the device. For each patient, physicians were asked to establish an exhaustive differential diagnosis based on the anamnesis and clinical examination. In the intervention group, residents read the AMHTD report before performing the anamnesis. In both the groups, a senior physician had to establish a differential diagnosis, considered as the gold standard, independent of the resident’s opinion and AMHTD report. Results A total of 29 patients were included in the intervention group and 30 in the control group. Differential diagnosis accuracy was higher in the intervention group (mean 75%, SD 26%) than in the control group (mean 59%, SD 31%; P=.01). Subgroup analysis showed a between-group difference of 3% (83% [17/21]-80% [14/17]) for low complexity cases (1-2 differential diagnoses possible) in favor of the AMHTD (P=.76), 31% (87% [13/15]-56% [18/33]) for intermediate complexity (3 differential diagnoses; P=.02), and 24% (63% [34/54]-39% [14/35]) for high complexity (4-5 differential diagnoses; P=.08). Physicians in the intervention group (mean 4.3, SD 2) had more years of clinical practice compared with the control group (mean 5.5, SD 2; P=.03). Differential diagnosis accuracy was negatively correlated to case complexity (r=0.41; P=.001) and the residents’ years of practice (r=0.04; P=.72). The AMHTD was able to determine 73% (SD 30%) of correct differential diagnoses. Patient satisfaction was good (4.3/5), and 26 of 29 patients (90%) considered that they were able to accurately describe their symptomatology. In 8 of 29 cases (28%), residents considered that the AMHTD helped to establish the differential diagnosis. Conclusions The AMHTD allowed physicians to make more accurate differential diagnoses, particularly in complex cases. This could be explained not only by the ability of the AMHTD to make the right diagnoses, but also by the exhaustive anamnesis provided.

scholarly journals Text Messaging Adherence Intervention for Adolescents and Young Adults with Chronic Kidney Disease: Pilot Randomized Controlled Trial and Stakeholder Interviews (Preprint)

2020 ◽  
Author(s):  
Cyd Eaton ◽  
Margaret Comer ◽  
Cozumel Pruette ◽  
Kevin Psoter ◽  
Kristin Riekert
Keyword(s):  
Randomized Controlled Trial ◽  
Young Adults ◽  
Medication Adherence ◽  
Active Control ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Significant Group ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

BACKGROUND Up to one-third of adolescents and young adults (11-21 years old) with chronic kidney disease exhibit suboptimal rates of adherence to renal-protective antihypertensive medications. Mobile health interventions may promote higher adherence to these medicines in these individuals, but empirical research is needed to inform best practices for applying these modalities. OBJECTIVE In this multiphase investigation, we developed and tested a theoretically informed text messaging intervention based on the COM-B model, a well-established health intervention framework stating that capability, opportunity, and motivation interactively modify health behaviors, to improve participants’ antihypertensive medication adherence in a pilot randomized controlled trial. Qualitative data on user experiences were obtained. METHODS In phase 1, intervention messages (Reminder+COM-B Message) were developed via stakeholder engagement of participants and pediatric nephrologists. In phase 2, the Reminder+COM-B Message intervention was tested against a Reminder-only Message active control condition in an 8-week pilot randomized controlled trial. The primary outcome was daily electronically monitored antihypertensive medication adherence and secondary outcomes included pre-post participant surveys of adherence self-efficacy, adherence barriers, outcome expectancies for taking medicine, and motivation for and importance of taking medicine. In phase 3, qualitative interviews related to user experiences were conducted with participants in the Reminder+COM-B Message intervention group. RESULTS Following phase 1, 34 participants (mean age 16.59 years, 41% female, 38% African American/Black, 35% hypertension diagnosis) completed the phase 2 pilot randomized controlled trial (n=18 in the Reminder+COM-B Message intervention group, n=16 in the Reminder-only Message active control group). All participants in the Reminder+COM-B Message intervention group completed a phase 3 qualitative interview. Overall, study procedures were feasible and the Reminder+COM-B Message intervention was acceptable to the participants (eg, 15/18 participants reported reading the majority of messages sent to them, 0/18 reported that the messages reduced their desire to take medicine). Prerandomization, there were no significant group differences in the rate of change in daily adherence over time. However, postrandomization, there was a significant group by time interaction (B=.01, <i>P</i>=.04) in which daily adherence decreased significantly over time in the Reminder-only Message active control group but remained stable in the Reminder+COM-B Message intervention group. There were no significant differences between groups in pre-post changes in survey responses. Qualitative interviews revealed participants’ perceptions of how the Reminder+COM-B Message intervention changed adherence behavior and highlighted several areas for improving the intervention (eg, adapt messaging timing, intensity, and content to match daily adherence, send praise when medicine is taken). CONCLUSIONS The Reminder+COM-B Message intervention was feasible and acceptable to adolescents/young adults and demonstrated potential to promote participants’ daily medication adherence beyond simple reminders. Further research is needed to determine the Reminder+COM-B Message intervention’s mechanisms of adherence behavior change and to incorporate qualitative participant feedback into a modified version of this intervention to enhance its acceptability. CLINICALTRIAL ClinicalTrials.gov NCT03651596; https://clinicaltrials.gov/ct2/show/NCT03651596

scholarly journals Text Messaging Adherence Intervention for Adolescents and Young Adults with Chronic Kidney Disease: Pilot Randomized Controlled Trial and Stakeholder Interviews

10.2196/19861 ◽  
2020 ◽  
Vol 22 (8) ◽  
pp. e19861
Author(s):  
Cyd Eaton ◽  
Margaret Comer ◽  
Cozumel Pruette ◽  
Kevin Psoter ◽  
Kristin Riekert
Keyword(s):  
Randomized Controlled Trial ◽  
Young Adults ◽  
Medication Adherence ◽  
Active Control ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Significant Group ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Background Up to one-third of adolescents and young adults (11-21 years old) with chronic kidney disease exhibit suboptimal rates of adherence to renal-protective antihypertensive medications. Mobile health interventions may promote higher adherence to these medicines in these individuals, but empirical research is needed to inform best practices for applying these modalities. Objective In this multiphase investigation, we developed and tested a theoretically informed text messaging intervention based on the COM-B model, a well-established health intervention framework stating that capability, opportunity, and motivation interactively modify health behaviors, to improve participants’ antihypertensive medication adherence in a pilot randomized controlled trial. Qualitative data on user experiences were obtained. Methods In phase 1, intervention messages (Reminder+COM-B Message) were developed via stakeholder engagement of participants and pediatric nephrologists. In phase 2, the Reminder+COM-B Message intervention was tested against a Reminder-only Message active control condition in an 8-week pilot randomized controlled trial. The primary outcome was daily electronically monitored antihypertensive medication adherence and secondary outcomes included pre-post participant surveys of adherence self-efficacy, adherence barriers, outcome expectancies for taking medicine, and motivation for and importance of taking medicine. In phase 3, qualitative interviews related to user experiences were conducted with participants in the Reminder+COM-B Message intervention group. Results Following phase 1, 34 participants (mean age 16.59 years, 41% female, 38% African American/Black, 35% hypertension diagnosis) completed the phase 2 pilot randomized controlled trial (n=18 in the Reminder+COM-B Message intervention group, n=16 in the Reminder-only Message active control group). All participants in the Reminder+COM-B Message intervention group completed a phase 3 qualitative interview. Overall, study procedures were feasible and the Reminder+COM-B Message intervention was acceptable to the participants (eg, 15/18 participants reported reading the majority of messages sent to them, 0/18 reported that the messages reduced their desire to take medicine). Prerandomization, there were no significant group differences in the rate of change in daily adherence over time. However, postrandomization, there was a significant group by time interaction (B=.01, P=.04) in which daily adherence decreased significantly over time in the Reminder-only Message active control group but remained stable in the Reminder+COM-B Message intervention group. There were no significant differences between groups in pre-post changes in survey responses. Qualitative interviews revealed participants’ perceptions of how the Reminder+COM-B Message intervention changed adherence behavior and highlighted several areas for improving the intervention (eg, adapt messaging timing, intensity, and content to match daily adherence, send praise when medicine is taken). Conclusions The Reminder+COM-B Message intervention was feasible and acceptable to adolescents/young adults and demonstrated potential to promote participants’ daily medication adherence beyond simple reminders. Further research is needed to determine the Reminder+COM-B Message intervention’s mechanisms of adherence behavior change and to incorporate qualitative participant feedback into a modified version of this intervention to enhance its acceptability. Trial Registration ClinicalTrials.gov NCT03651596; https://clinicaltrials.gov/ct2/show/NCT03651596

scholarly journals Medication Adherence Support of an In-home Electronic Medication Dispensing System for Individuals living with Chronic Conditions: A Pilot Randomized Controlled Trial

2020 ◽  
Author(s):  
Mubashir Arain ◽  
Armghan Ahmad ◽  
Venus Chiu ◽  
Lorena Kembel
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Chronic Conditions ◽  
Controlled Trial ◽  
Medication Management ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Abstract Background: Medication adherence is challenging for older adults due to factors, such as the number of medications, dosing schedule, and the duration of drug therapy. The objective of this study was to examine the effectiveness of an in-home electronic medication dispensing system (MDS) on improving medication adherence and health perception in older adults with chronic conditions.Methods: A pilot Randomized Controlled Trial (RCT) was conducted using a two-arm parallel assignment model. The intervention group used an MDS as their medication management method. The control group continued to use their current methods of medication management. Block randomization was used to assign participants into the intervention or control group. The inclusion criteria included 1) English speaking 2) age 50 and over 3) diagnosed with one or more chronic condition(s) 4) currently taking five or more oral medications 5) City of Calgary resident. Participants were recruited from a primary care clinic in Alberta, Canada. The study was open label where knowledge about group assigned to participants after randomization was not withheld. Medication adherence was captured over a continuous, six-month period and analyzed using Intention-to-Treat (ITT) analysis.Results: A total of 91 participants were assessed for eligibility and 50 were randomized into the two groups. The number of participants analyzed for ITT was 23 and 25 in the intervention and control group, respectively. Most of the demographic characteristics were comparable in the two groups except mean age of the intervention group, which was higher compared to the control group (63.96±7.86 versus 59.52±5.93, p-value=0.03). The average recorded adherence over 26 weeks was significantly higher in the intervention group than the control group (98.35%±2.15% versus 91.17%±9.76%, p<0.01). The self-rated medication adherence in the intervention group also showed a significant increase from baseline to 6-month (7.63±1.63 versus 9.13±0.81, p<0.01). The control group showed a non-significant increase (7.20±1.74 versus 8.27±2.09, p=0.07).Conclusion: MDS can be an effective, long-term solution to medication non-adherence in older adults experiencing chronic conditions and taking multiple medications. The technology induces better consistency and improvement in medication taking behaviour than simple, non-technological intervention.Trial Registration: Registered with ClinicalTrials.gov on April 09, 2020 with identifier NCT04339296.

scholarly journals Medication adherence support of an in-home electronic medication dispensing system for individuals living with chronic conditions: a pilot randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mubashir Aslam Arain ◽  
Armghan Ahmad ◽  
Venus Chiu ◽  
Lorena Kembel
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Chronic Conditions ◽  
Controlled Trial ◽  
Medication Management ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Abstract Background Medication adherence is challenging for older adults due to factors such as the number of medications, dosing schedule, and the duration of drug therapy. The objective of this study was to examine the effectiveness of an in-home electronic medication dispensing system (MDS) on improving medication adherence and health perception in older adults with chronic conditions. Methods A pilot Randomized Controlled Trial (RCT) was conducted using a two-arm parallel assignment model. The intervention group used an MDS as their medication management method. The control group continued to use their current methods of medication management. Block randomization was used to assign participants into the intervention or control group. The inclusion criteria included 1) English speaking 2) age 50 and over 3) diagnosed with one or more chronic condition(s) 4) currently taking five or more oral medications 5) City of Calgary resident. Participants were recruited from a primary care clinic in Alberta, Canada. The study was open-label where knowledge about group assigned to participants after randomization was not withheld. Medication adherence was captured over a continuous, six-month period and analyzed using Intention-to-Treat (ITT) analysis. Results A total of 91 participants were assessed for eligibility and 50 were randomized into the two groups. The number of participants analyzed for ITT was 23 and 25 in the intervention and control group, respectively. Most of the demographic characteristics were comparable in the two groups except the mean age of the intervention group, which was higher compared to the control group (63.96 ± 7.86 versus 59.52 ± 5.93, p-value = 0.03). The average recorded adherence over 26 weeks was significantly higher in the intervention group than the control group (98.35% ± 2.15% versus 91.17% ± 9.76%, p < 0.01). The self-rated medication adherence in the intervention group also showed a significant increase from baseline to 6-month (Z=-2.65, p < 0.01). The control group showed a non-significant increase (Z=-1.79, p = 0.07). Conclusion The MDS can be an effective, long-term solution to medication non-adherence in older adults experiencing chronic conditions and taking multiple medications. The technology induces better consistency and improvement in medication taking behaviour than simple, non-technological intervention. Trial registration Registered with ClinicalTrials.gov on April 09, 2020 with identifier NCT04339296.

scholarly journals The efficacy of the novel zinc-containing desensitizer CAREDYNE Shield on dentin hypersensitivity: a study protocol for a pilot randomized controlled trial

2020 ◽  
Author(s):  
Takashi Matsuura ◽  
Megumi Mae ◽  
Masayuki Ohira ◽  
Yasunori Yamashita ◽  
Ayako Nakazono ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Study Protocol ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Dentin Hypersensitivity ◽  
Root Caries ◽  
The Novel ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Abstract Background: Dentin hypersensitivity (DH) is a condition characterized by short and sharp pain which will arise in response to tactile, chemical, thermal, evaporative or osmotic stimuli. The painful symptoms cause discomfort in patients and reduce their quality of life. Recently, the novel zinc-containing desensitizer CAREDYNE Shield has been developed as a new type of desensitizer that acts by inducing chemical occlusion of dentinal tubules, and releasing zinc ion for root caries prevention. However, the clinical effectiveness of CAREDYNE Shield on DH remains unclear. Therefore, the aim of this study is to evaluate the effectiveness of CAREDYNE Shield on DH by comparing with that of another desensitizer Nanoseal commonly used in Japan.Methods/Design: This study protocol is a two-arm parallel pilot randomized controlled trial. Forty DH patients will be randomly allocated to two groups. Participants in the intervention group will be treated with CAREDYNE Shield, while those in the control group will be treated with Nanoseal. The primary outcome is the reduction of pain intensity in response to air stimuli measured with a five-points verbal response scale from baseline to four weeks after the intervention, and Fisher's exact test will be used for analyses.Discussion: CAREDYNE Shield can be casually applied to subgingival areas and proximal surfaces because it reacts with only tooth substance. Furthermore, zinc has been reported to reduce the demineralization of enamel and dentin and inhibit biofilm formation, plaque growth and dentin collagen degradation. Therefore, CAREDYNE Shield may be expected to be a useful novel desensitizer that acts not only as a desensitizer but also as a root caries inhibitor.Trial registration:UMIN Clinical Trials Registry (UMIN-CTR), UMIN000038072. Registered on 21st September 2019.Trial statusThis study (protocol version number: version 1.4.0; approved on 22 October 2019) is ongoing. The recruitment of participants began in December 2019 and will be continued until November 2020 (1).

Wristband Accelerometers to motiVate arm Exercises after Stroke (WAVES): a pilot randomized controlled trial

2019 ◽  
Vol 33 (8) ◽  
pp. 1391-1403 ◽  
Author(s):  
Ruth H Da-Silva ◽  
Sarah A Moore ◽  
Helen Rodgers ◽  
Lisa Shaw ◽  
Louise Sutcliffe ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Total Sample ◽  
Control Group ◽  
Intervention Participant ◽  
Serious Adverse Events ◽  
Post Stroke ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Objective: To evaluate the feasibility of a multicentre, observer-blind, pilot randomized controlled trial (RCT) of a wristband accelerometer with activity-dependent vibration alerts to prompt impaired arm use after stroke. Design: Parallel-group pilot RCT. Setting: Four English stroke services. Participants: Patients 0–3 months post stroke with a new arm deficit. Intervention: Participants were randomized to wear a prompting or ‘sham’ wristband during a four-week self-directed therapy programme with twice-weekly therapy review. Main outcomes: Recruitment, retention and adherence rates, safety and completion of assessments were reported. Arm recovery was measured by Action Research Arm Test (ARAT) and Motor Activity Log (MAL) without statistical comparison. Results: In total, 33 patients were recruited (0.6 per month/site; median time post stroke: 26 days (interquartile range (IQR):15.5–45)). Baseline, four-week and eight-week median (IQR) ARAT for the control group ( n = 19) were 15 (2–35), 35 (15–26) and 31 (21–55) and those for the intervention group (n = 14) were 37 (16–45), 57 (29–57) and 57 (37–57), respectively; for MAL Amount of Use, the corresponding values in the control group were 0.2 (0.0–1.2), 1.1 (0.3–2.9) and 1.2 (0.7–2.9) and in the intervention group were 1.4 (0.5–2.6), 3.8 (1.9–4.5) and 3.7 (2.1–4.3). Four participants withdrew from the study. Wristbands were worn for 79% of the recommended time. The intervention and control group participants received a median of 6.0 (IQR: 4.3–8.0) and 7.5 (IQR: 6.8–8.0) therapy reviews. A median of 8 (IQR: 6–10) prompts were delivered per intervention participant/day. Research assessments were completed for 28/29 and 25/28 patients at four and eight weeks. Eight serious adverse events were reported, all unrelated to the intervention. Conclusion: A multicentre RCT of wristband accelerometers to prompt arm activity early after stroke is feasible. A total sample of 108 participants would be required.

scholarly journals The efficacy of a novel zinc-containing desensitizer CAREDYNE Shield on dentin hypersensitivity: study protocol for a pilot randomized controlled trial

2020 ◽  
Author(s):  
Takashi Matsuura ◽  
Megumi Mae ◽  
Masayuki Ohira ◽  
Yasunori Yamashita ◽  
Ayako Nakazono ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Study Protocol ◽  
Controlled Trial ◽  
Intervention Group ◽  
Verbal Response ◽  
Control Group ◽  
Dentin Hypersensitivity ◽  
Root Caries ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Abstract Background: Dentin hypersensitivity (DH) is a condition characterized by short and sharp pain which will arise in response to tactile, chemical, thermal, evaporative or osmotic stimuli. The painful symptoms cause discomfort to the patients and decrease their quality of life. Recently, a novel zinc-containing desensitizer CAREDYNE Shield is developed. It is a new type of desensitizer which acts as a desensitizer by inducing chemical occlusion of dentinal tubules, and releases zinc ion for root caries prevention. However, the clinical effectiveness of CAREDYNE Shield on DH is still unclear. Therefore, the aim of this study is to evaluate the effectiveness of CAREDYNE Shield on DH by comparing with that of another desensitizer Nanoseal commonly used in Japan.Methods/Design: This study protocol is a two-arm parallel pilot randomized controlled trial. Forty DH patients will be randomly allocated into 2 groups. Participants in the intervention group will be treated with CAREDYNE Shield; participants in the control group will be treated with Nanoseal. Primary outcome is the reduction of pain intensity in response to air stimuli measured with 5-points verbal response scale from baseline to 4 weeks after the intervention and Fisher's exact test will be used for analysis.Discussion: CAREDYNE Shield can be casually applied to subgingival areas and proximal surfaces because it reacts with only tooth substance. Moreover, zinc is reported to reduce the demineralization of enamel and dentin and inhibit biofilm formation, plaque growth and dentin collagen degradation. Therefore, CAREDYNE Shield may be expected to become a novel useful desensitizer which act not only as a desensitizer but also as a root caries inhibitor.

scholarly journals Differential Diagnosis Assessment in Ambulatory Care With an Automated Medical History–Taking Device: Pilot Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Adrien Jean-Pierre Schwitzguebel ◽  
Clarisse Jeckelmann ◽  
Roberto Gavinio ◽  
Cécile Levallois ◽  
Charles Benaïm ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Differential Diagnosis ◽  
Controlled Trial ◽  
Intervention Group ◽  
Differential Diagnoses ◽  
Control Group ◽  
History Taking ◽  
Randomized Controlled ◽  
Diagnosis Accuracy ◽  
Pilot Randomized Controlled Trial

BACKGROUND Automated medical history–taking devices (AMHTDs) are emerging tools with the potential to increase the quality of medical consultations by providing physicians with an exhaustive, high-quality, standardized anamnesis and differential diagnosis. OBJECTIVE This study aimed to assess the effectiveness of an AMHTD to obtain an accurate differential diagnosis in an outpatient service. METHODS We conducted a pilot randomized controlled trial involving 59 patients presenting to an emergency outpatient unit and suffering from various conditions affecting the limbs, the back, and the chest wall. Resident physicians were randomized into 2 groups, one assisted by the AMHTD and one without access to the device. For each patient, physicians were asked to establish an exhaustive differential diagnosis based on the anamnesis and clinical examination. In the intervention group, residents read the AMHTD report before performing the anamnesis. In both the groups, a senior physician had to establish a differential diagnosis, considered as the gold standard, independent of the resident’s opinion and AMHTD report. RESULTS A total of 29 patients were included in the intervention group and 30 in the control group. Differential diagnosis accuracy was higher in the intervention group (mean 75%, SD 26%) than in the control group (mean 59%, SD 31%; <italic>P</italic>=.01). Subgroup analysis showed a between-group difference of 3% (83% [17/21]-80% [14/17]) for low complexity cases (1-2 differential diagnoses possible) in favor of the AMHTD (<italic>P</italic>=.76), 31% (87% [13/15]-56% [18/33]) for intermediate complexity (3 differential diagnoses; <italic>P</italic>=.02), and 24% (63% [34/54]-39% [14/35]) for high complexity (4-5 differential diagnoses; <italic>P</italic>=.08). Physicians in the intervention group (mean 4.3, SD 2) had more years of clinical practice compared with the control group (mean 5.5, SD 2; <italic>P</italic>=.03). Differential diagnosis accuracy was negatively correlated to case complexity (<italic>r</italic>=0.41; <italic>P</italic>=.001) and the residents’ years of practice (<italic>r</italic>=0.04; <italic>P</italic>=.72). The AMHTD was able to determine 73% (SD 30%) of correct differential diagnoses. Patient satisfaction was good (4.3/5), and 26 of 29 patients (90%) considered that they were able to accurately describe their symptomatology. In 8 of 29 cases (28%), residents considered that the AMHTD helped to establish the differential diagnosis. CONCLUSIONS The AMHTD allowed physicians to make more accurate differential diagnoses, particularly in complex cases. This could be explained not only by the ability of the AMHTD to make the right diagnoses, but also by the exhaustive anamnesis provided.

Sign in / Sign up

Export Citation Format

Share Document