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Ethics approval
This study was performed in line with the principles of the Declaration of Helsinki and approved by the Human Research Ethics Committees at Edith Cowan University (Ref. no. 2019-00311-SCHOFIELD, 07/05/2019), Sir Charles Gairdner Hospital (Ref. no. 03094, 20/12/2019), and St John of God Hospital, Subiaco (Ref. no. 1516,...
PMC10132425
Consent to participate
All participants provided written informed consent.
PMC10132425
Competing interests
The authors declare no competing interests.
PMC10132425
References
PMC10132425
2. Materials and Methods
This pilot study used a prospective descriptive design. Institutional review board approval was obtained from the University. Study inclusion criteria for women are (1) between the ages of 18 and 42, (2) menstrual cycle length of 21 to 42 days, (3) had not used depot medroxyprogesterone acetate over the past 12 months,...
PMC9960263
3. Results
PMC9960263
3.1. Participant Demographics
A total of 30 women consented to participate. The mean age was 33.47 (range 26–42, SD 4.76). All participants were Caucasian and had some college education. All 30 participants initiated the testing and charting. One participant achieved a desired pregnancy after the first cycle and withdrew from the study. The partici...
PMC9960263
3.2. Cycle Data and Ovulation Detection
The 30 participants contributed 84 menstrual cycles. The average cycle length was 28.82 days (range 24–38, SD 3.62). The LH surge was detected in 94% of the cycles by the CBFM, 82% by the Premom LH test strips, and 95% by EAH LH test strips. The correlation of the Premom peak day with the CBFM first peak was r = 0.99; ...
PMC9960263
3.3. User Satisfaction and Ease-of-Use Rating
Overall, the participants reported significantly higher satisfaction and ease-of-use ratings for the CBFM compared to the Premom LH testing or the EAH LH testing. For the Premom LH group, the mean score for the CBFM was 51.29 (SD 4.56) vs. 43.07 (SD 11.82) for the Premom testing (t = 2.66; df = 13; When comparing the i...
PMC9960263
4. Discussion
In the 1980s, scientists determined that one of the best predictors of the beginning of the fertile phase was the rise in estrogen and the urine metabolite E3G [Both monitoring systems are intended for women who want to become pregnant and target the most fertile days of the menstrual cycle. Premom and EAH LH testing h...
PMC9960263
5. Conclusions
There is a boom in reproductive mobile health monitoring systems and more women are exploring these options for fertility monitoring or family planning purposes [
PMC9960263
Author Contributions
Conceptualization, Q.M. and R.J.F.; methodology, Q.M. and R.J.F.; software, Q.M.; formal analysis, Q.M. and R.J.F.; data curation, Q.M.; writing—original draft preparation, Q.M.; writing—review and editing, Q.M. and R.J.F. All authors have read and agreed to the published version of the manuscript.
PMC9960263
Institutional Review Board Statement
The study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of Marquette University on January 28, 2020 (Approval number: HR-3553).
PMC9960263
Informed Consent Statement
Informed consent was obtained from all subjects involved in the study.
PMC9960263
Data Availability Statement
Not applicable.
PMC9960263
Conflicts of Interest
The authors declare no conflict of interest.
PMC9960263
References
Comparison of the demographic parameters between the two study groups.Abbreviations: BMI, body mass index; LH, luteinizing hormone.Menstrual cycle parameters for the two study groups based on the CBFM.Abbreviations: CBFM, Clearblue Fertility Monitor; LH, luteinizing hormone.Premom quantitative LH levels in relation to ...
PMC9960263
Background
While audit & feedback (A&F) is an effective implementation intervention, the design elements which maximize effectiveness are unclear. Partnering with a healthcare quality advisory organization already delivering feedback, we conducted a pragmatic, 2 × 2 factorial, cluster-randomized trial to test the impact of variat...
PMC10173488
Methods
SECONDARY
Eligible physicians worked in nursing homes in Ontario, Canada, and had voluntarily signed up to receive the report. Groups of nursing homes sharing physicians were randomized to (A) physicians’ individual prescribing rates compared to top-performing peers (the top quartile) or the provincial median and (B) risk-framed...
PMC10173488
Results
Two hundred sixty-seven physicians (152 clusters) were randomized: 67 to arm 1 (median benchmark, benefit framing), 65 to arm 2 (top quartile benchmark, benefit framing), 75 to arm 3 (median benchmark, risk framing), and 60 to arm 4 (top quartile benchmark, risk framing). There were no significant differences in the pr...
PMC10173488
Conclusions
Risk framing and a top quartile comparator have the potential to achieve change. Further work to establish the strategies most likely to enhance A&F engagement, particularly with physicians who may be most likely to benefit from feedback, is required to support meaningfully addressing intricate research questions conce...
PMC10173488
Trial registration
ClinicalTrials.gov,
PMC10173488
Supplementary Information
The online version contains supplementary material available at 10.1186/s13012-023-01271-6.
PMC10173488
Keywords
Head-to-head trials investigating ways to optimize audit and feedback impact are lacking but feasible within organizations already delivering feedbackThis head-to-head trial was unable to fully determine the effect of theory- and evidence-based variations in (i) the benchmark used for comparison (median vs. top quarti...
PMC10173488
Background
Audit and Feedback (A&F) involves measuring a provider’s practice, comparing it to a benchmark, and relaying this information back to the provider to encourage change [In A&F reports, provider data are often compared to an average: for example, the median prescribing rate for physicians is a specific region. However, a...
PMC10173488
Methods
Our methods are described in detail in the published protocol [
PMC10173488
Trial design
This was a 2 × 2 factorial, pragmatic, cluster-randomized trial with an embedded process evaluation. The trial is registered on ClinicalTrials.gov (NLM identifier: NCT02979964).
PMC10173488
Setting
This trial took place in the province of Ontario, Canada. Ontario Health (OH—formerly Health Quality Ontario at the time of the study), the provincial advisor on quality in healthcare, supports quality improvement through various initiatives. One such initiative is their “Practice Reports,” whereby confidential, aggreg...
PMC10173488
Participants
Eligible physicians were those working in the nursing home sector in Ontario who had (i) voluntarily signed up to receive their report prior to randomization and (ii) consistently had > 5 residents that they cared for in the nursing home setting (to allow for adequate data capture). The participating research ethics bo...
PMC10173488
Interventions and mechanisms of action
Full details of the history of the report and its re-design in preparation for this trial were reported previously [
PMC10173488
Manipulated feature 1—The benchmark
Previously, the report compared physicians’ data to provincial and regional averages. OH felt that a benchmark of the top 10% of peers used in previous research [
PMC10173488
Manipulated feature 2—Information framing
We developed a “risk-framed” and a “benefit-framed” version of the report. The risk-framed version focused on the proportion of residents prescribed high-risk medication. Risk-framing was presented visually (a graph demonstrating the percentage of patients at risk, with red colouring), and in text form (“Thus, four var...
PMC10173488
Outcomes
SECONDARY
The primary outcome was the mean number of central nervous system (CNS)-active medications per resident per month, with the primary endpoint for analysis being 6 months post-intervention. CNS-active medications included antipsychotics, opioids, benzodiazepines, and antidepressants (including tricyclic antidepressants a...
PMC10173488
Data collection
depression, pain
In this pragmatic trial, we used provincial health administrative data to assess baseline characteristics and outcomes. Data were compiled from (1) the Ontario Drug Benefits database, which covers nearly all prescriptions in nursing homes; (2) the Canadian Institute for Health Information databases covering all inpatie...
PMC10173488
Randomization
To prevent contamination due to physicians working across multiple homes, the unit of randomization was groups of one or more nursing homes sharing physicians. All eligible physicians were included in the clusters. An independent statistician randomized these clusters independently to the two factors (resulting in four...
PMC10173488
Sample size
We anticipated having approximately 160 clusters, with an average of 350 beds per cluster. In a 2 × 2 factorial design assuming no interaction and similar effects for each factor, a test of each intervention at 6 months in an ANCOVA design would achieve 90% power to detect an absolute mean difference of 0.3 in the prim...
PMC10173488
Blinding
BLIND
Participants were not explicitly blinded, but the risks of this were felt to be minimal, given that the physician were not aware of the variations being tested nor the outcome measures. The analysts were blind to allocation status.
PMC10173488
Data analysis
REGRESSION, SECONDARY
Descriptive characteristics of nursing home residents included variables assessed as part of the RAI assessment: therefore, only those residents for whom a recent RAI assessment had been completed were included in the analysis of resident characteristics at baseline. Primary outcome analyses included the broader popula...
PMC10173488
Process evaluation
Physicians who downloaded their report were sent an email invitation to complete a questionnaire which assessed the proposed mechanisms of action outlined in Fig. Questionnaire participants who indicated interest were invited to take part in a telephone interview. The interview topic guide focused on report use and ide...
PMC10173488
Results
PMC10173488
Recruitment
Cluster and participant flow through the study is presented in Additional file
PMC10173488
Report engagement
Of the 266 physicians analyzed, 76 (28.6%) in 60 clusters downloaded their report at the December 2016 release (19 (28.4%) physicians (13 clusters) in arm 1, 17 (26.6%) physicians (15 clusters) in arm 2, 23 (30.7%) physicians (16 clusters) in arm 3, and 17 (28.3%) physicians (16 clusters) in arm 4).
PMC10173488
Baseline resident characteristics
Baseline characteristics of nursing home residents for whom a recent RAI assessment had been completed in each arm and overall (December 1, 2016) are summarized in Table Baseline resident characteristicsAnalyses of baseline characteristics restricted to nursing home residents for whom a recent RAI assessment had been c...
PMC10173488
Effects of A&F variants on monthly number of CNS-active medications prescribed
REGRESSION
Primary outcome analyses included the broader population of included physicians’ residents (i.e., not only those with a recent RAI assessment). The mean number of CNS-active medications prescribed per resident at the baseline month (December 1, 2016) and at the last follow-up time point (July 1, 2017) are displayed in ...
PMC10173488
Participants’ intentions to adjust their prescribing were high before receiving the report
All participants highlighted their pre-existing intention to review medications and appropriately adjust their prescribing. Some also acknowledged that the report may have enhanced this. This corresponded to the CFIR domain “Yeah so whether I look at this report or not I know for myself that I need to minimize the use ...
PMC10173488
A comparator representing a higher target has the potential to influence prescribing behaviour change, if physicians identify with it
Participants indicated that comparing their performance to others was a key motivation for using the report. Participants who received the median comparator and those that received the top quartile comparator (a higher target) indicated that they aimed to achieve similar prescribing rates to the comparator. It also app...
PMC10173488
Benefit-framed feedback is not immediately actionable and impedes report usability
Those receiving the benefit-framed report were vocal about the framing and found it difficult and time-consuming to visualize and interpret their data. They preferred a risk-framed report as this format matches other reports they receive and is viewed as more practical. Benefit framing therefore appears to decrease rep...
PMC10173488
Indicator selection may have hindered behaviour change efforts
Participants stated that of the three indicators, responding to the antipsychotic medication indicator by appropriately adjusting their prescribing was more of a priority than responding to the benzodiazepine indicator. Prioritisation of the “three or more specified CNS-active medications” indicator (i.e., the trial pr...
PMC10173488
Physicians value the report and suggested enhancements to help them monitor and discuss progress on improvement efforts at specific facilities
dementia
Participants noted that in summarizing prescribing data over a period of time, the report provides data not otherwise available and complements individual resident data already available. Some noted that the report informs discussions with other nursing home team members by “armoring” them with information. However, al...
PMC10173488
Discussion
PMC10173488
Summary of findings
We investigated the impact of variations in the benchmark used for comparison, and in information framing, on the effectiveness of A&F. In accordance with theory and evidence, we hypothesized that greater improvements in practice would be achieved when feedback recipients were compared to the top quartile rather than t...
PMC10173488
Interpretation and implications for the design and delivery of A&F
fits
Around 35% of eligible physicians signed up for the report. However, under 30% of the physicians who signed up subsequently downloaded their reports. We therefore could not answer our relatively intricate research questions due to a lack of engagement. Previous work with this report showed that antipsychotic prescribin...
PMC10173488
Strengths and limitations
This trial demonstrates a successful partnership between researchers and health systems stakeholders to pragmatically investigate the impact of variations in the design of A&F focused on a topic of clinical importance in our context and already delivered at scale. This is the first in a series of studies aimed at optim...
PMC10173488
Conclusions
fits
This head-to-head trial of A&F delivered at scale found no impact of variations in either the benchmark used for comparison, or the framing of information, on physician prescribing of CNS-active medications to nursing home residents. However, we could not fully answer our research questions due to a lack of engagement ...
PMC10173488
Acknowledgements
We are grateful to all of the participants for taking part in this research. We would also like to thank the staff at Ontario Health Quality for their work on the development and implementation of the intervention and Yingbo Na for running the trial analysis.
PMC10173488
Authors’ contributions
JP
NMI led the development of the protocol, obtained the funding, led the development of the study design, and contributed to all other aspects of the study. NMc contributed to the process evaluation methods; led the process evaluation data collection, analysis, and interpretation; contributed to the interpretation of the...
PMC10173488
Funding
This study was funded by the Ontario SPOR SUPPORT Unit, which is supported by the Canadian Institutes of Health Research and the Province of Ontario. The funding source had no role in the study design, collection, analysis or interpretation of the data, writing the manuscript, or the decision to submit the paper for pu...
PMC10173488
Availability of data and materials
Trial data access is governed by the policies at ICES. Process evaluation data are available from the corresponding author on reasonable request.
PMC10173488
Declarations
PMC10173488
Ethics approval and consent to participate
Ethics approval was granted by the University of Toronto Research Ethics Board (#00032455) and the Women’s College Hospital Research Ethics Board (#2016–0122-E) for the trial and the Ottawa Health Science Network Research Ethics Board (#20160934-01H) for the process evaluation. Ethics approval included approval of a de...
PMC10173488
Consent for publication
Not applicable.
PMC10173488
Competing interests
JP
JP is an Associate Editor of Implementation Science, and JMG and NMI are members of the editorial board. They were not involved in any decisions made about this manuscript. The authors declare that they have no other competing interests.
PMC10173488
References
PMC10173488
Background:
RLS, neurological disease
RESTLESS LEGS SYNDROME (RLS), NEUROLOGICAL DISEASE
Restless legs syndrome (RLS) is a common neurological disease that has a significant impact on daily activities and quality of life, for which there is often no satisfactory therapy. Complementary medicine, such as acupressure and hydrotherapy, is used to treat patients with RLS; however, the clinical evidence is uncle...
PMC10313283
Methods:
Anxiety, restless-legs syndrome, RLS-severity, RLS, Depression
DISEASE, COLD
This is a randomized, controlled, open-label, exploratory, clinical study with 3 parallel arms, comparing both self-applied hydrotherapy (according to the German non-medical naturopath Sebastian Kneipp) and acupressure in addition to routine care in comparison to routine care alone (waiting list control) in patients wi...
PMC10313283
Conclusion:
RLS
In the case of clinically relevant therapeutic effects, feasibility, and therapeutic safety, the results will be the basis for planning a future confirmatory randomized trial and for helping to develop further RLS self-treatment concepts.
PMC10313283
1. Introduction
PMC10313283
1.1. Background and rationale
loss of social networks, comorbidity, Willis-Ekbom disease, WED, anxiety, sleep disorders, RLS/WED, neurological disorder, inflammation, autoimmune diseases, metabolic diseases, depressive, polyneuropathy, RLS-, RLS, depression, cardiac and renal diseases, sleep-related
DISORDER, WILLIS-EKBOM DISEASE, NEUROLOGICAL DISORDER, PARKINSON DISEASE, DIABETES MELLITUS, AUTOIMMUNE DISEASES, NEURODEGENERATIVE DISEASES, INFLAMMATION, DISEASE, METABOLIC DISEASES, DISORDERS, RESTLESS LEGS SYNDROME (RLS), WED, IRON DEFICIENCY, MULTIPLE SCLEROSIS, POLYNEUROPATHY, COLD, DISEASES
Restless legs syndrome (RLS), also known as Willis-Ekbom disease (WED), is a common neurological disorder characterized by agonizing sensations in the legs, occurrence at rest, and compelling urge to move the legs (or arms or sometimes other body parts).RLS symptoms of any frequency and severity occur in 5% to 10% of t...
PMC10313283
1.2. Study aims
RLS
The aim of this clinical study is to assess the feasibility and effects of self-administered acupressure and Kneipp hydrotherapy in patients with RLS, and to gather preliminary information on both study interventions as a basis for conducting a high-quality confirmatory trial including a valid sample size calculation.
PMC10313283
2. Methods
PMC10313283
2.1. Study design
RESTLESS LEGS SYNDROME
The HYDRAC study (HYDRotherapy and ACupressure for Restless legs syndrome) is a prospective, parallel, 3-armed, interventional, exploratory clinical study. The study will be conducted for 12 weeks per patient, including a self-treatment phase of 6 weeks and a follow-up phase for another 6 weeks with optional self-treat...
PMC10313283
2.2. Patients and recruitment
long-coronavirus disease syndrome, Raynaud disease, psoriasis, RLS, dermatological disease
ACUTE INFECTION, VIRUS, RAYNAUD DISEASE, CIRCULATORY DISORDERS, DISEASE, ATOPIC DERMATITIS, RECRUITMENT, PSORIASIS, CORONAVIRUS, HEART, SEVERE ACUTE RESPIRATORY SYNDROME, DERMATOLOGICAL DISEASE
A total of 51 patients (n = 17 in each arm) included in the trial. Patients who meet the following inclusion criteria will be included in the study: age between 18 and 75 years; diagnosis of RLS confirmed by a trained medical specialist (“Facharzt”) in accordance with the diagnostic criteria,Patients who meet any of th...
PMC10313283
2.3. Study physicians
acupuncture/acupressure
Both study physicians (JS and JK) fulfill the following requirements: knowledge of data protection, ICH-good clinical practice guidelines, content and procedure of the study, and instructions for the study interventions. They received detailed instruction and supervision by long-standing experts in hydrotherapy accordi...
PMC10313283
2.4. Study interventions
PMC10313283
2.4.1. Hydrotherapy according to Kneipp
RESTLESS LEGS SYNDROME, COLD
Patients in the hydrotherapy group will be trained by the study physicians on the day of randomization and will receive an illustrated manual. Hydrotherapy should be performed semi-standardized with obligatory and optional affusions. The patients perform the treatments twice daily for 6 weeks. After week 6, further tre...
PMC10313283
2.4.2. Acupressure
RESTLESS LEGS SYNDROME
Patients in the acupressure group will be trained by the study physicians after inclusion and randomization, and will also receive an illustrated manual. Acupressure should be performed in a standardized manner with a 6 acupuncture point set according to the rules and principles of Chinese Medicine,HYDRAC study: Scheme...
PMC10313283
2.4.3. Waiting list group
Patients in the waitlist group continue to take their routine medication and will not receive any additional training during the intervention and follow-up periods. They have the option to receive free hydrotherapy or acupressure training by one of the study physicians after completing the study.Medically necessary tre...
PMC10313283
2.4.5. Blinding procedures
Due to the nature of Kneipp hydrotherapy and acupressure, patients and study physicians cannot be blinded. To minimize bias, all outcomes at baseline and 6 and 12 weeks after randomization will be evaluated by the same independent, experienced investigators blinded to the group assignment. After the completion of the s...
PMC10313283
2.4.6. Randomization
Randomization will be performed centrally based on a computer-generated randomization list (generated using R software (version 4.1.2)) and will be block randomization with variable block length. Allocation to the 3 groups will be in a 1:1:1 ratio. Randomization will be performed at the end of the inclusion examination...
PMC10313283
2.5. Sample size calculation
RLS
As this is an exploratory study to generate the first results and further queries about the effect of hydrotherapy and acupressure in patients with RLS, we did not make a sample size estimation. As we expect about 10% of the patients to drop out of the study before week 12; 17 randomized patients per group (51 randomiz...
PMC10313283
2.6. Attendance and drop-outs
The attendance of each patient is recorded by the return and evaluation of diaries and questionnaires. Dropouts and reasons for dropout will be recorded in the study database.
PMC10313283
2.7. Statistical methods
REGRESSION
All data collected are analyzed descriptively: means, standard deviation, median and quartile, or frequencies and percentages (overall and separated by intervention group). Endpoints are analyzed graphically and in an exploratory manner, and depending on the scale, performed using analysis of covariance or logistic reg...
PMC10313283
2.8. Data collection and management
The personally identifiable data are entered and managed in a password-protected MS Access database and serve as a re-identification list. The database resides on a separate project drive, with limited accessibility. Data from the survey instruments are entered in pseudonymized form into a SoSci-Survey online database ...
PMC10313283
2.9. Withdrawal criteria and management
massive deterioration
ADVERSE EVENT
Patients may or must withdraw from the study if the continuation of the study imposes an unreasonable burden on the patient because of the patient condition, if a serious adverse event occurs and a causal relationship is established by the study director, if patients request withdrawal from the study and/or there is a ...
PMC10313283
2.10. Oversight and monitoring
PMC10313283
2.10.1. Safety monitoring
EVENTS, ADVERSE EVENT
Together with the study documents, all patients will receive the necessary contact information to report any serious events directly to the Institute of Social Medicine, Epidemiology and Health. Serious Adverse Events must be reported by the study physicians to the study management within 24 hours of being known.
PMC10313283
2.10.2. Dissemination plans
The authors intend to publish the results of this study in peer-reviewed journals and present them at local and international conferences. A summary of the results can be provided to the patients who participated at their request.
PMC10313283
3. Discussion
Restless Legs Syndrome, RLS/WED, anxiety, RLS-severity, RLS, depression
RECRUITMENT, RESTLESS LEGS SYNDROME
The present exploratory RCT will be the first to investigate whether there is evidence for the effects of self-applied Kneipp hydrotherapy and acupressure in patients with RLS and whether it is reasonable to conduct a subsequent confirmatory study in a larger patient population.Our requirement is that the inclusion and...
PMC10313283
3.1. Strength and limitations of the study
RLS
This study is the first to investigate 2 non-drug therapy options for RLS that could expand the current treatment spectrum through self-applicable, openly accessible, and cost-effective measures. On the one hand, both therapies can be implemented in addition to the existing routine therapy, and, on the other hand, they...
PMC10313283
Acknowledgments
We would like to thank the entire study team, including Margit Cree and Katharina Kleinsteuber (members of the HYDRAC study secretary) for their outstanding work on this study.
PMC10313283
Abbreviations:
RESTLESS LEGS SYNDROME
restless-legs-syndromerestless-legs-syndrome quality of life questionnairestatistical package for social sciencesWillis-Ekbom diseaseMT and JS contributed equally to this work.Trial registration: This study was registered in the German Clinical Trial Registry (number DRKS00029960) on August 09, 2022.Ethics approval and...
PMC10313283
References
PMC10313283
Background
EMA
Ecological momentary assessments (EMAs) are short, repeated surveys designed to collect information on experiences in real-time, real-life contexts. Embedding periodic bursts of EMAs within cohort studies enables the study of experiences on multiple timescales and could greatly enhance the accuracy of self-reported inf...
PMC10623229
Objective
EMA
We aimed to evaluate the effects of study design features on EMA response rates.
PMC10623229
Methods
EMA
Embedded within an ongoing cohort study (Health@NUS), 3 bursts of EMAs were implemented over a 7-month period (April to October 2021). The response rate (percentage of completed EMA surveys from all sent EMA surveys; 30-42 individual EMA surveys sent/burst) for each burst was examined. Following a low response rate in ...
PMC10623229
Results
Participants (N=384) were university students (n=232, 60.4% female; mean age 23, SD 1.3 y) in Singapore. Changing the reward structure did not significantly change the response rate (
PMC10623229
Conclusions
EMA
Small changes to the implementation strategy (SMS text messages instead of emails) may have contributed to increasing the response rate over time. Changing the available rewards did not lead to a significant difference in the response rate, whereas changing the schedule length did lead to a significant difference in th...
PMC10623229
Trial Registration
ClinicalTrials.gov NCT05154227; https://clinicaltrials.gov/ct2/show/NCT05154227
PMC10623229
Methods
EMA
This study evaluated participants’ response rates to the first 3 bursts of EMA surveys nested within an ongoing prospective cohort study, Health@NUS (ClinicalTrials.gov NCT05154227).
PMC10623229
Health@NUS
EMA
Full details of Health@NUS are available elsewhere [The schedule for the first burst of Health@NUS EMA surveys was designed based on the available literature [
PMC10623229