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PMC10390614
Introduction
postoperative pain, LFCN block, pain, fractures, femoral head necrosis, THA
DISEASES, COMPLICATIONS, DEEP VEIN THROMBOSIS
Total hip arthroplasty (THA) is a widely used method for treating hip fractures, femoral head necrosis, and other diseases. Early postoperative lower limb functional exercise and ambulation after THA are important for relieving pain and reducing the risk of complications such as deep vein thrombosis [At present, there ...
PMC10390614
Materials and methods
PMC10390614
Recruitment and randomization
This study was registered in the Chinese Clinical Trial Registry (ChiCTR2100051521) and secured by the Ethics Committee of the First Affiliated Hospital of Chongqing Medical University on 6/16/2021. After signing the informed consent, a total of 92 patients undergoing elective one- sided THA were enrolled over a period...
PMC10390614
Ultrasound-guided block procedures
anterior inferior iliac spine, fascia iliaca block, pain, femoral cutaneous nerve, transverse abdominus muscle
LOCAL INFILTRATION, INFILTRATED
Peripheral vein access was established after the patients entered operating room, and non-invasive blood pressure (NIBP), heart rate (HR), and peripheral capillary oxygen saturation (SpOPENG + LFCN block: The low-frequency curvilinear probe (3–5 MHz) of ultrasound (GE Logiq e, GE Healthcare, USA) was placed in a transv...
PMC10390614
Anesthesia and postoperative analgesia
nerve block, pain
Following the nerve block, patients received general anesthesia administered by an anesthesiologist who was blinded to the allocation result. All the patients were treated with 10 mg of intravenous dexamethasone before surgery. For anesthesia induction, propofol (2.0–2.5 mg/kg), sufentanil (0.4–0.5 μg/kg), and vecuroni...
PMC10390614
The primary outcome
Our primary outcome was “time to first walk”, defined as the duration between the end of surgery and the first time the patient was able to walk with the assistance of a walking aid under the guidance of a rehabilitation physician.
PMC10390614
The secondary outcomes
nerve block-related, paresthesia, postoperative nausea and vomiting, dislocation, pain, hip flexion, PONV
FLICKERING, PARESTHESIA, CONTRACTION, SECONDARY, COMPLICATIONS
The secondary outcomes postoperatively included intraoperative remifentanil consumption, the degree of hip flexion on the operative side at 6 h, 24 h, and 48 h, lower limb muscle strength of the operative side at 6 h, 24 h, and 48 h, static and dynamic pain scores at 6 h, 24 h, and 48 h, the number of rescue analgesia,...
PMC10390614
Sample size calculation
We used PASS 16.0 software to calculate the sample size. Based on our preliminary study, we estimated that the first postoperative walking time of the S-FICB group would be 27.6 ± 12.3 h and the PENG + LFCN group would be 18.5 ± 12.3 h value. Under these assumptions, with
PMC10390614
Statistical analysis
We performed statistical analysis using IBM SPSS Statistics 20.0 software. Continuous variables with normal distribution were expressed as mean (SD) or percentage (%), and we used median (range) to express continuous variables that presented skewed distribution. Student’s
PMC10390614
Acknowledgements
We thank Xiaohong Wang, Daiyu Chen, and Qian Yang for their help with writing the manuscript and their expertise.
PMC10390614
Author contributions
All authors contributed to the study conception and design. Material preparation, data collection, and analysis were performed by KH, CZ, and WD. The first draft of the manuscript was written by LL and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.
PMC10390614
Funding
No funds, grants, or other support was received.
PMC10390614
Data availability
The data that support the findings of this study are available from the corresponding author upon reasonable request.
PMC10390614
Declarations
PMC10390614
Conflict of interest
No conflicts of interest.
PMC10390614
References
PMC10390614
Abstract
PMC10320042
Introduction
Effective PrEP use is critical for impact, but data are limited on common patterns of continuation and coverage among persons using PrEP in real‐world settings.
PMC10320042
Methods
REGRESSION
Data are from the Partners Scale‐Up Project, a programmatic stepped‐wedge cluster‐randomized trial to integrate PrEP delivery in 25 Kenyan public health facilities conducted between February 2017 and December 2021. We evaluated PrEP continuation using visit attendance and pharmacy refill records, and computed medicatio...
PMC10320042
Results
Overall, 4898 persons initiated PrEP, 54% (2640) were female, mean age was 33 years (standard deviation 11) and 84% (4092) had partners living with HIV. PrEP continuation was 57%, 44%, and 34% at 1, 3, and 6 months, respectively. Four unique trajectories of PrEP coverage were identified: (1) one‐fourth (1154) exhibited...
PMC10320042
Conclusions
two‐fifths
In this analysis of a real‐world PrEP implementation programme in Kenya, we found four distinct patterns of PrEP continuation, with one‐third of users exhibiting consistent high continuation throughout 12 months and two‐fifths with immediate discontinuation patterns. These data may help guide tailored interventions to ...
PMC10320042
INTRODUCTION
MAY
Oral pre‐exposure prophylaxis is a highly effective HIV prevention strategy for men and women when taken with its effectiveness highly dependent on adherence [Access to oral PrEP in real‐world settings is gradually scaling up in many African settings, including in Kenya which officially launched PrEP implementation in ...
PMC10320042
METHODS
PMC10320042
Setting and population
Data are from the Partners Scale‐Up Project (ClinicalTrials.gov: NCT03052010) which has previously been reported [
PMC10320042
Procedures for PrEP initiation
The primary objective of the project was to sustainably catalyse scale‐up of PrEP delivery and to study the process of integrating PrEP services within existing public health structures. Thus, all direct PrEP delivery services, including PrEP demand creation, HIV risk assessment, PrEP eligibility determination, HIV tes...
PMC10320042
Procedures for follow‐up of clients on PrEP
Clients who initiated PrEP were followed according to the Kenya national PrEP guidelines [
PMC10320042
Data collection
For this programmatic project, all clinical and programme data were documented by the facility staff on MOH tools that include PrEP registers and the clinical encounter form which is the standard MOH form for documenting individual‐level clinical records for clients on PrEP, and pharmacy logs for tracking drug prescrip...
PMC10320042
Analysis
SECONDARY
The present analysis was restricted to the individuals’ first year of PrEP use. We conducted secondary data analysis of the parent Partners Scale‐Up Project to identify trajectories of PrEP continuation and coverage and factors associated with assignment to the different PrEP continuation trajectories. The primary outc...
PMC10320042
RESULTS
Overall, a total of 4898 individuals initiated PrEP in the Partners Scale‐Up project between February 2017 and June 2020; 2640 (54%) were female, mean age was 33 years (standard deviation 11), the majority were married and monogamous (75%), and 4092 (84%) reported to have a partner known to live with HIV (Table Baselin...
PMC10320042
Baseline demographic and behaviour characteristics by trajectory
Overall, among the 4898 persons who initiated PrEP, we identified four unique patterns of PrEP coverage during the first year of PrEP use classified as: (1) consistent high coverage, (2) high coverage, (3) moderate coverage, and (4) immediate discontinuation. The consistent high coverage group comprised 23.6% (1154) of...
PMC10320042
Patterns of coverage and continuation on PrEP by identified group trajectory
The graphic and quantitative representation of the four distinct trajectories of PrEP coverage are shown in Table Quantitative summary of quarterly PrEP coverage and continuation by group trajectoryViolin scatter plot of coverage (MPR) over 12 months, by group trajectory. *Presents the distribution of the PrEP coverage...
PMC10320042
Correlates of assignment to the respective trajectory class membership
REGRESSION
Results from the multinomial logistic regression model are presented in Figure Forest plot of relative risk ratios and 95% confidence intervals of being assigned to each trajectory relative to the “immediate discontinuation” group trajectory for various baseline demographic and behaviour characteristics.
PMC10320042
DISCUSSION
prevention‐effectiveness, HIV serodifferent couples
In this evaluation of a large programmatic PrEP project in Kenyan public health HIV care clinics, we found moderate continuation on PrEP with a high drop‐off for most clients within 6 months post‐initiation that was characterized by four unique PrEP continuation patterns. More than a third of the individuals exhibited ...
PMC10320042
CONCLUSIONS
In this analysis from a large real‐world PrEP implementation programme in Kenyan facilities, we found evidence of distinct patterns of persistence and continuation on PrEP, with more than one‐third of the study population exhibiting patterns of consistent high PrEP continuation throughout the first 12 months of use. Th...
PMC10320042
COMPETING INTERESTS
JMB is an employee of Gilead Sciences. KKM has received an Investigator Sponsored Research Grant from Gilead Sciences not related to this work awarded to the University of Washington. All other authors declare no competing interests.
PMC10320042
FUNDING
R01MH123267
The study was supported by the National Institute of Mental Health of the US National Institutes of Health (grants R01MH095507, R00MH118134, R01MH123267 and R01AI155086) and the Bill & Melinda Gates Foundation (grant OPP10556051). The project funders had no role in the study design or writing of the report.
PMC10320042
AUTHORS’ CONTRIBUTIONS
Study conceptualization and funding acquisition: KKM and JMB. Data collection tool development: KKM, EMI, JM, and SP. Data collection: KKM, EMI, BN, KN, EB, NM, JO, JM, and SP. Project administration: KKM, EMI, JMB, EB, NM, JO, and JM. Data analysis: TS and AP. Writing—original draft: AP and KKM. Writing—review and edi...
PMC10320042
Supporting information
Supplemental file 1: PrEP Rapid Assessment Screening Tool.Click here for additional data file.Supplemental file 2: Goodness of fit values for the different number of groups in the model.Click here for additional data file.Figure S1Click here for additional data file.
PMC10320042
ACKNOWLEDGEMENTS
We thank the men and women who participated in this project and the staff at implementing facilities and all the project staff for their motivation and dedication.
PMC10320042
DATA AVAILABILITY STATEMENT
Public sharing of individual participant data was not included in the informed consent form of the project and cannot be posted in a supplemental file or a public repository because of legal and ethical restrictions. De‐identified data underlying this project can be made available to interested researchers upon reasona...
PMC10320042
REFERENCES
PMC10320042
Background
Chronic pain, pain
CHRONIC PAIN
Chronic pain conditions involve numerous physical and psychological challenges, and while psychosocial self-management interventions can be of benefit for people living with chronic pain, such in-person treatment is not always accessible. Digital self-management approaches could improve this disparity, potentially bols...
PMC10492177
Objective
pain
CHRONIC PAIN
This randomized controlled trial aimed to evaluate the short-term efficacy of EPIO (ie, inspired by the Greek goddess for the soothing of pain, Epione), a digital self-management intervention, for people living with chronic pain.
PMC10492177
Methods
Patients (N=266) were randomly assigned to either the EPIO intervention (n=132) or a care-as-usual control group (n=134). Outcome measures included
PMC10492177
Results
pain
The participants were primarily female (210/259, 81.1%), with a median age of 49 (range 22-78) years and a variety of pain conditions. Analyses (n=229) after 3 months revealed no statistically significant changes for the primary outcome of pain interference (
PMC10492177
Conclusions
depression, pain
CHRONIC PAIN
Evidence-informed, user-centered digital pain self-management interventions such as EPIO may have the potential to effectively support self-management and improve psychological functioning in the form of reduced symptoms of depression and improved capacity to regulate thoughts, feelings, and behavior for people living ...
PMC10492177
Trial Registration
ClinicalTrials.gov NCT03705104; https://clinicaltrials.gov/ct2/show/NCT03705104
PMC10492177
Introduction
PMC10492177
Background
chronic pain, Chronic pain, pain
CHRONIC PAIN
Chronic pain conditions are common and can be disabling and distressing [Psychological treatment approaches such as cognitive behavioral therapy (CBT) [Digital solutions may have the potential to improve outreach and provide easy and relatively low-cost access to pain self-management interventions [In response to the i...
PMC10492177
Objectives
depression, fatigue, anxiety, pain
SECONDARY
This study aimed to examine short-term (ie, 3 months) efficacy findings from an RCT testing the digital pain self-management intervention program EPIO. It was hypothesized that participants receiving EPIO, compared with participants in a care-as-usual control group, would experience significant improvements in primary ...
PMC10492177
Methods
PMC10492177
Study Design
pain
A 2-armed RCT was used with participants randomly assigned to (1) the digital pain self-management intervention program EPIO or (2) a care-as-usual control group.
PMC10492177
Participants and Recruitment
pain, psychosis, psychological illness, migraine, chronic pain, cancer-related pain
MIGRAINE, CHRONIC PAIN
Participants were people living with chronic pain, recruited from November 2019 to February 2021 through a major medical institution (Oslo University Hospital, Norway), collaborating with local health care services and primary care practices, social media channels, and patient organizations’ web pages. The eligibility ...
PMC10492177
Study Procedure
chronic pain
CHRONIC PAIN
Patients living with chronic pain were verbally informed about the EPIO study by collaborating partners or through flyers at various health care sites. If interested, the patient’s contact information was forwarded to the project team, who then provided additional information about study participation to those interest...
PMC10492177
The EPIO Intervention Program
chronic pain
CHRONIC PAIN, MUSCLE RELAXATION
The app-based EPIO program consists of 9 CBT-based modules with aspects of ACT, each combining educational information (eg, thought challenges, coping strategies, values, and activity pacing) with practical and related exercises (eg, diaphragmatic breathing, progressive muscle relaxation, visualization, and mindfulness...
PMC10492177
Care-As-Usual Control Group
Participants in the care-as-usual control group completed the study outcome measures at baseline and at 3 months, without any additional follow-up from the research team. The project team did not seek to monitor or control any type of additional care potentially sought by participants in the care-as-usual control group...
PMC10492177
Data Collection and Outcome Measures
TSD
All questionnaires and outcome measures were completed by the participants (ie, self-report) using the secure TSD server. Participants completed a study-specific sociodemographic and disease-related questionnaire at baseline, and outcome measures were collected at baseline (ie, before randomization) and at 3 months (ie...
PMC10492177
Psychosocial Outcome Measures
PMC10492177
System Use, Usefulness, and Ease of Use
TSD
Details related to use and program progress (ie, system use) were collected automatically, stored on a secure research server (ie, TSD), and later extracted in accordance with informed consent and existing safety and privacy regulations. At the 3-month follow-up, participants completed a 6-item study-specific questionn...
PMC10492177
Power Analysis and Sample Estimates
eHealth interventions for comparable samples have shown a Cohen
PMC10492177
Statistical Analyses
depression, fatigue, anxiety, pain
REGRESSION
Baseline characteristics, usefulness, ease of use, and user patterns were summarized with means and SDs for normally distributed variables and medians and ranges for variables with skewed distributions. The type of distribution was assessed using the visual inspection of histograms and q-q plots and by comparing means ...
PMC10492177
Ethics Approval, Informed Consent, and Participation
TSD
The study was registered in ClinicalTrials.gov (NCT03705104) and approved by the Regional Committee for Medical and Health Research Ethics (REK 2018/8911) and the Hospital Privacy Protection Committee (ie, institutional review board equivalent; PVO 2017/6697). The study method and results were reported following the CO...
PMC10492177
Results
PMC10492177
Group Differences
SECONDARY
Primary and secondary outcomes, assessing between-group differences in changes from baseline to the 3-month follow-up, are reported in
PMC10492177
System Use, Usefulness, and Ease of Use
In total, 63 of 125 (50.4%) participants in the intervention group completed at least 6 of the 9 modules within the 3-month study period and were considered completers. There were no significant differences in sociodemographic variables or outcome measures (ie, MD in change) between program completers and noncompleters...
PMC10492177
Discussion
PMC10492177
Principal Findings
chronic pain, fatigue, anxiety, pain
CHRONIC PAIN, SECONDARY
In this RCT, people with chronic pain having access to the digital pain self-management intervention EPIO, compared with care-as-usual controls, did not report statistically significantly different changes in the primary outcome of pain interference on function after 3 months nor in the secondary outcomes of anxiety, H...
PMC10492177
Study Limitations, Strengths, and Future Directions
chronic pain, pain
CHRONIC PAIN
This study had several limitations. First, participants were recruited through social media and by collaborating with project partners, which may suggest that the study population consisted of highly motivated individuals. Therefore, it is not clear whether people with chronic pain would, in general, be interested in o...
PMC10492177
Conclusions
chronic pain, depressive symptoms, fatigue, pain
CHRONIC PAIN, RECRUITMENT
Digital pain self-management interventions, such as EPIO, delivered in a simple blended care model, may have the potential to support self-management and improve coping and psychological functioning for people living with chronic pain. Despite not showing a statistically significant impact on the primary outcome of pai...
PMC10492177
Abbreviations
Depression, Anxiety, Pain
acceptance and commitment therapyBrief Pain Inventorycognitive behavioral therapyConsolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and Online TelehealthChronic Pain Acceptance QuestionnaireHospital Anxiety and Depression Scalehealth-related quality of lifemean differenceMedical Res...
PMC10492177
Data Availability
Data sets from this study are, due to the nature of patient-sensitive information, not available for public sharing through public archives or repositories. However, deidentified data from this study will be made available in accordance with institutional standards upon contacting the corresponding author.
PMC10492177
Aims
The CHA
PMC10465382
Materials and methods
atrial fibrillation
ATRIAL FIBRILLATION
This is an observational analysis of 1127 atrial fibrillation patients previously enrolled in the MISOAC-AF trial. After a median 2.6-year follow-up period, baseline and follow-up CHA
PMC10465382
Results
The mean baseline, follow-up, and Delta CHA
PMC10465382
Conclusion
atrial fibrillation
ATRIAL FIBRILLATION
In atrial fibrillation patients, changes in CHA
PMC10465382
Trial registration
This is an observational, post-hoc analysis of the MISOAC-AF randomized controlled trial, registered on ClinicalTrials.gov (identifier: NCT02941978; registered: October 21, 2016).
PMC10465382
Supplementary Information
The online version contains supplementary material available at 10.1007/s00380-023-02278-1.
PMC10465382
Keywords
Open access funding provided by HEAL-Link Greece.
PMC10465382
Introduction
stroke, cardiac arrhythmias, arrhythmia, AF
CARDIAC ARRHYTHMIAS, ATRIAL FIBRILLATION (AF), ARRHYTHMIA, STROKE, DISEASE
Atrial fibrillation (AF) dominates the field of cardiac arrhythmias by being the most common arrhythmia globally, with a rapidly increasing occurrence and an extensive disease burden [As the majority of AF patients are among the elderly population, they present with an inconstant variety of stroke risk-contributing com...
PMC10465382
Materials and methods
PMC10465382
Study population
non-valvular Atrial Fibrillation
This study constitutes a post-hoc, observational analysis of the MISOAC-AF trial (Motivational Interviewing to Support Oral Anti Coagulation adherence in patients with non-valvular Atrial Fibrillation, ClinicalTrials.gov identifier: NCT02941978), a prospective randomized controlled trial, conducted in the cardiology wa...
PMC10465382
Data collection
All associated data, such as demographic and baseline clinical characteristics, personal information, medication history and baseline CHA
PMC10465382
Data processing and statistical analysis
stroke
STROKE, EVENTS, ISCHEMIC STROKE
The investigated outcome was the incidence of ischemic stroke. The electronic records were used in conjunction with the details provided during the follow-up interviews, to determine stroke events and the onset of any new comorbidities. All the above data were used to calculate the participants’ follow-up CHAFollowing ...
PMC10465382
Results
PMC10465382
Impact of the Delta CHA
The Kaplan–Meier curve for the stroke-free probability, for different Delta CHAKaplan – Meier analysis survival curves for separate groups of Delta CHA
PMC10465382
Predictive validity of the Delta CHA
The ROC curve for the baseline, follow-up, and Delta CHAReceiver operating characteristics (ROC) curve for the Baseline, Follow-up, and Delta CHA
PMC10465382
Discussion
stroke, CHF
CHF, STROKE
This observational study indicates the dynamic state of stroke risk in patients with AF, as assessed through the CHAThe predictive value of Delta CHAThe Delta CHAA more recent study appraised the association of Delta CHAEvidently, the previous studies enforced strict enrollment criteria to their participants. With the ...
PMC10465382
Limitations of the study
The observational nature of the study may involve limitations. The relatively small study sample may be a potential liability compared to previously performed research. However, the less restrictive enrollment criteria allowed a more adequate representation of real conditions. The determination of only two CHA
PMC10465382
Conclusions
stroke
STROKE
The stroke risk in AF patients is non-static, as demonstrated by the changes in their CHA
PMC10465382
Acknowledgements
None.
PMC10465382
Author contributions
AS and ID conceived the study. AS, ASP, AK, and DVM were responsible for patient enrollment and follow-up. ET, EG, OK, and AB were involved in data acquisition. ET, AS, and ASP performed the statistical analyses. AT and GG had the overall study supervision. ET and AT wrote the original draft of the manuscript. All auth...
PMC10465382
Funding
Open access funding provided by HEAL-Link Greece. No financial support was received for the present or the original (MISOAC-AF) study or publication of this article.
PMC10465382
Data availability
Anonymized data can be made available upon reasonable request to the corresponding author.
PMC10465382
Declarations
PMC10465382
Conflict of interest
The authors declare that they have no conflict of interest.
PMC10465382
Ethical approval
Study approval was obtained by the Ethics Committee of the Aristotle University of Thessaloniki (Reference 173/30.11.2015). The study was performed in line with the principles of the Declaration of Helsinki.
PMC10465382
Consent to participate
Written informed consent was obtained from the patients prior to their participation to this study.
PMC10465382
References
PMC10465382
Background
chronic whiplash-associated disorders, WADs
Neck-specific exercises (NSE) supervised by a physiotherapist twice a week for 12 weeks have shown good results in chronic whiplash-associated disorders (WADs), but the effect of exercise delivered via the internet is unknown.
PMC10337460