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Participants and Study Recruitment Procedures | RECRUITMENT, DISEASE | Recruitment was conducted at the Guangzhou Lingnan Community Support Center (hereinafter, Lingnan), a local MSM-friendly HIV testing clinic supported by the Guangzhou Center for Disease Control and Prevention (CDC) [Potential participants were recruited according to the unit of an egocentric social network, which included 1 core member (ego) and several network members (alters), with the tie of HIV e-report delivery. The e-reports were only accessible to MSM who had undergone HIV testing at Lingnan. Ego recruiters were defined as MSM who underwent offline HIV testing at Lingnan and met the inclusion criteria. After agreeing to participate in this study as recruiters and filling in the written consent form, they shared their e-reports via the WeChat (Tencent Holdings Ltd.) mini-program “ChaBei” (an app for online booking of HIV test appointments, online-to-offline referral, offline clinic testing registration, and HIV e-report delivery) to their WeChat MSM contacts. Egos were randomly assigned to the exchangeable HIV e-report or regular HIV e-report group through the WeChat mini-program “ChaBei.” Alters were the MSM contacts who received and read the shared reports; those who click the link will be candidate alters in our study. An online page that provides study details will be presented to the candidate alters after they read the content of ego’s report. Those interested in this study will be asked to complete the screening questionnaire and eligible individuals will fill in an online consent form and become alters.The specific details of e-reports distributed through “ChaBei” were described in our published protocol [ | PMC10337306 | |
Assessments | PMC10337306 | |||
Recruitment Outcomes | ’ transformation, MSM, alter-egos | RECRUITMENT | The first recruitment outcome was whether egos recruited alters completing online enrollment by delivering HIV e-reports. Egos who successfully recruited alters were defined as ego-RA; otherwise they were defined as ego-NRA. For the first outcome, egos were the target population for analysis. The second recruitment outcome was alters’ transformation into alter-egos. Alters were considered to have transformed into offline ego recruiters for the subsequent recruitment wave (hereinafter “alter-egos”) when they had transformed from online to offline egos after they tested for HIV at Lingnan and received an HIV e-report. For the second outcome, alters were the target population for analysis. Alter-egos delivering HIV e-reports to their friends in the MSM community could expand recruitment in subsequent waves. From these data, we created 2 dichotomous dependent variables: (1) whether ego successfully recruited alters; and (2) whether alter transformed into alter-ego.Additionally, when e-report online delivery was identified as a significant influencing factor for recruitment, it was further applied as a dependent variable to explore its influencing factors. | PMC10337306 |
Independent Variables | PMC10337306 | |||
Associations Between Egos’ Characteristics and Alters’ Online Enrollment | type of HIV e-report | The following egos’ characteristics were included as independent variables to analyze their influence on alters’ online enrollment: demographic characteristics, socioeconomic status, MSM-related information, and HIV e-report delivery information. Demographic characteristics were age, marital status, education level, length of residence in Guangzhou, and registered permanent residence. The socioeconomic status variable was monthly income. MSM features contained sexual orientation, sex roles, main venues to make gay friends, and anal sexual intercourse. HIV e-report online delivery information included type of HIV e-report, the number and duration of viewing own/others’ e-report, the number of times forwarding the e-report, and the number of people/times clicked on e-report. | PMC10337306 | |
Associations Between Alters’ Characteristics and Alters’ Transformation into Alter-Egos | sexual behavior, HIV testing, preference for HIV testing, ’ transformation, HIV testing social norms, infection, alter-egos | INFECTION, RECRUITMENT | The following alters’ characteristics were included as independent variables to analyze their influence on alters’ transformation into offline ego recruiters (alter-egos) for the second recruitment wave: demographic characteristics, socioeconomic status, MSM-related information, HIV e-report delivery information, HIV/sexually transmitted infection (STI) testing information, high-risk sexual behavior, HIV-related information, and social network characteristics. HIV/STI testing information included HIV testing, preference for HIV testing, STI testing, and self-report STI status. High-risk sexual behavior included having regular/casual partners in the past 3 months, having unprotected anal intercourse (UAI) with regular/casual partners in the past 3 months, and awareness of the HIV status of regular/casual partners. HIV-related information included intervened by any HIV prevention program, HIV risk perceptions, HIV stigma, and HIV testing social norms.The variables included in the egocentric social network analysis were similarity of characteristics, which is defined as the degree of consistency of demographic characteristics between each respondent (ego) and each of his associates (alter); and strength of relational ties, which is measured by the degree of relational intimacy. Demographic characteristics such as age, education, marriage, and income were collected from egos and alters, and similarities in social attributes between them were calculated using an edit distance algorithm [where | PMC10337306 |
Data Collection | WeChat-based, sexual behavior, ’ | RECRUITMENT, RECRUITMENT | Egos’ demographic characteristics, socioeconomic status, and MSM-related information were collected face-to-face through well-trained surveyors in Lingnan using an electronic standardized questionnaire.Alters’ demographic characteristics, socioeconomic status, MSM-related information, HIV/STI testing information, high-risk sexual behavior, and HIV-related information were collected online using an electronic standardized questionnaire.Recruitment outcomes, egos’ and alters’ HIV e-report online delivery information, and alters’ social network data were obtained from participant recruitment logs and data recorded through the WeChat-based data portal. | PMC10337306 |
Data Analysis | PMC10337306 | |||
Descriptive Analysis of Overall Recruitment | RECRUITMENT, RECRUITMENT | The social network visualization graph was used to show the overall recruitment situation. Recruitment outcomes were compared between the 2 arms of the RCT. Continuous variables with normal or near-normal distribution are described as the mean (SD) and were compared between groups using the Student | PMC10337306 | |
Regression Analysis of Recruitment-Associated Factors | Two-part, alter-egos | REGRESSION, RECRUITMENT | Two-part models were fitted to estimate correlates of alters who had successfully enrolled. In the first part, a logistic regression model was used to estimate the probability of alters who successfully enrolled among those to whom egos had forwarded e-reports. In the second part, for egos that successfully recruited alters, the number of alters recruited was estimated using ordinary least squares regression. In addition, factors associated with e-report delivery were analyzed using logistic regression. As a relatively small percentage of alters transformed into alter-egos in the subsequent recruitment waves, Firth’s penalized likelihood [ | PMC10337306 |
Qualitative Analysis | ’ transformation | RECRUITMENT, PBC | Qualitative interviews were conducted to understand the facilitators of and barriers to online alters’ transformation into offline egos for subsequent recruitment waves. The qualitative interviews were focused on 2 primary topics: alters’ demand for appointment-based HIV testing services and the utilization of e-reports. All the recorded data were transcribed into text and imported into ATLAS.ti 6.2 (ATLAS.ti GmbH) software for analysis. The textual information was coded according to the research objectives and interview outline, and the comparative method was used for multistage data thematic analysis, data mining by coding and categorizing, and screening meaningful content.All data management and statistical analyses were conducted using RStudio for Windows (version 1.4.1103; RStudio, PBC). A social network visualization graph was obtained using Gephi 0.9.4 for Windows (Gephi Team). All tests were 2-sided, and significance was set at | PMC10337306 |
Ethical Considerations | The study was reviewed and approved by the Ethics Committee of Sun Yat-sen University (Institutional Review Board number 054/19; February 28, 2019) and confirmed by Lingnan before the study. Participation in this study was voluntary and all data were made anonymous. We included only those that had provided written or online informed consent. Egos received a compensation of 20 RMB (≈US $3) for each alter recruited, and alters received a compensation of 50 RMB (≈US $7.5) after completing the questionnaire. Compensation was issued through a reward (E-Red Pocket) on WeChat. | PMC10337306 | ||
Results | PMC10337306 | |||
Recruitment Outcomes and Associated Factors at First Wave | PMC10337306 | |||
Qualitative Results About Barriers for Alters’ Transformation into Offline Alter-Egos | PMC10337306 | |||
Overview | WeChat-based | Qualitative interviews were conducted with 8 participants: 5 alters (A1-A5) and 3 alter-egos (B1-B3). The major barriers to transformation from online alters to offline egos (ie, the reasons why online alters did not undergo HIV testing at Lingnan and thus did not transform into alter-egos) were (1) low awareness of the functions of the WeChat-based mini-program “ChaBei” for booking HIV testing services, (2) limited access to HIV e-reports at offline testing facilities, and (3) no demand for offline HIV testing. | PMC10337306 | |
Awareness of the Functions of the WeChat-Based Mini-Program “ChaBei” | WeChat-based | SAID | “ChaBei” is a WeChat-based tool to promote HIV testing in Guangzhou, China. Some participants believed in the authenticity and anonymity of HIV e-reports. B1 stated, “I think testing at healthcare facilities will be more accurate than self-testing.” B3 said, “I think Lingnan Center’s e-reports are as reliable as hospitals’ test reports.” Some alters were educated about the functions of “ChaBei” by egos when the egos forwarded them the e-reports. These alters then proceeded to make appointments on “ChaBei” and underwent testing. B1 stated, “My friend said that this place could do the testing for free, so I booked an appointment.” However, some MSM were not familiar with “ChaBei” and expressed that the mini-program was not well advertised and not well known. A1 said, “There are probably few people using this app at the moment, and you need to make advertisements for ChaBei.” Consequently, they were not familiar with the functions of “ChaBei.” A5 said, “I didn’t use this mini-program because I don’t know how to use it.” They were also concerned about privacy problems. A1 said, “I don’t know about the mini-program, so I’m worried about its privacy.” These barriers prevented alters from opening HIV e-reports and using the mini-program to make appointments. | PMC10337306 |
Inadequate Access to HIV e-Reports at Offline Testing Service Facilities | At the time of this study, “ChaBei” was a recently developed app and initially only allowed appointment booking at Lingnan; therefore, participants who tested at Lingnan were able to obtain HIV e-reports. Despite 60% of MSM in Guangzhou undergoing HIV testing at Lingnan [ | PMC10337306 | ||
Demand for Offline HIV Testing | sexual behavior, alter-egos | SAID | The alter-egos preferred regular offline HIV testing. B2 stated, “I find it convenient to book tests online.” B3 said, “I am mainly in the habit of regular testing.” Among alters who did not transform, some expressed that they did not have high-risk sexual behavior or regular testing habits. A5 said, “I don’t need to get tested; I haven’t had high-risk sexual behavior.” Some preferred self-testing. A2 stated, “I am most used to using test strips because it is convenient and I can test whenever I want.” | PMC10337306 |
Discussion | PMC10337306 | |||
Principal Findings | communicable disease, MSM | COMMUNICABLE DISEASE, RECRUITMENT | This study assessed the use of HIV e-reports as a tool for recruiting MSM participants for an HIV testing study via social networks. Similar to offline recruitment, MSM egos forwarded their e-reports to more MSM peers (thus, to larger active social networks) and were thus more likely to recruit alters for the study. However, unlike offline recruitment, the success and sustainability of online recruitment were found to depend on high levels of familiarity and awareness among MSM, with the “ChaBei” tool used for delivering e-reports to their network associates. Remarkably, the exchangeable e-report associated with alter’s transformation into offline ego means that it might promote MSM to test HIV offline to get their own e-report for exchange with others. This indicates that promoting awareness and increasing recognition of online communicable disease reporting tools are crucial for effectively reaching and recruiting high-risk individuals.This study recruited sufficient eligible alters (n=1162) from the distribution of HIV e-reports in online social networks, although the recruitment was conducted over 2 years during the COVID-19 pandemic. Compared with traditional recruitment methods in previous studies, the recruitment methods in this study showed improved recruitment efficiency. For example, Rhodes et al [Egos in the regular HIV e-reports group had a higher probability of successful recruitment on alters’ online enrollment, which may be attributed to the increased accessibility of others’ test results in the regular HIV e-report group. After the regular e-reports were forwarded, report receivers could directly see the test results [Egos who forwarded e-reports to more MSM recruited more alters and more frequently viewed their own and others’ e-reports. The number of times e-reports were forwarded showed a strong positive association with the size of the social network, which is consistent with previous studies that used social networks for participant recruitment [Our recruitment strategy demonstrated an effective and sustainable recruitment mechanism. e-Reports were forwarded many times in social networks in the first, second, and third waves, creating multiple recruitment waves ( | PMC10337306 |
Limitations | MAY | This study has several limitations that should be acknowledged. First, the implementation of this study was affected by the COVID-19 pandemic, particularly during the lockdown period (February to May 2020) in China during which HIV testing services were disrupted. Second, this study lacked sufficient resources to investigate alters who failed to be recruited by egos, which is essential to guide future efforts for e-report promotion in such populations. Third, this was a baseline analysis for an RCT targeting alters; as such, available data on egos’ characteristics were insufficient. Therefore, qualitative interviews were conducted to explore the reasons for forwarding and not forwarding e-reports. | PMC10337306 | |
Conclusions | communicable diseases, WeChat-based, communicable disease, infectious disease | COMMUNICABLE DISEASES, RECRUITMENT, INFECTIOUS DISEASE, REGRESSION, COMMUNICABLE DISEASE | This study recruited sufficient MSM to participate in an HIV testing intervention study through the delivery of HIV e-reports in social networks using a WeChat-based mini-program “ChaBei.” The delivery of e-reports was acceptable in MSM social networks. The HIV e-report exchange mechanism might promote MSM to test HIV offline to get their own e-report for exchange in the community and thus achieve sustainability of recruitment. Further, promoting awareness and increasing recognition of online communicable disease reporting tools are key to ensuring the success and sustainability of online recruitment. This study provides a feasible and sustainable recruitment strategy to trace the direct contacts of individuals with communicable diseases for early testing and participation in infectious disease research.This study was supported by the National Natural Science Foundation of China (grants 71974212, 72204059), Guangdong Basic and Applied Basic Research Foundation (grant 2020A1515010737), and Science and Technology Program of Guangzhou, China (grant 202201010078). Mr Qi Liu, Mr Gang Meng, and Mr Jie Lu (Guangzhou Lingnan Community Support Center) assisted with WeChat-based mini-program development and ego offline recruitment. Tailing Chen, Sha Chen, and Jinyue Li (all from School of Public Health); Minghui Zhang (from School of Life Science); and Yijun Guo (from School of Pharmaceutical Science, Sun Yat-sen University) assisted with offline and online recruitment. Professional English language editing support was provided by AsiaEdit.Authors' Contributions: JSL wrote the manuscript and conducted all statistical analyses. FSH participated in the research design, data collection design, and manuscript revision. YHL is the co-principal investigator responsible for the online part of this project, including research design, WeChat-based mini-program design, management, and supervision. XRF conducted baseline and follow-up data collection, quality control, project implementation, and manuscript revision. JLQ and QLY participated in the research design, data collection design, project launch, beginning of baseline data collection, beginning of baseline quality control, and beginning of baseline project implementation. JG, JHL, and DRX participated in the research design, data collection design, and part of human and funding resources support during the project implementation. YZG is the co-principal investigator responsible for site works, including research design, WeChat-based mini-program design, clinic and telephone data collection, management, and supervision. CH is the principal investigator of this project in the management and leadership of the research project.Conflicts of Interest: None declared.Characteristics of egos and alters, results of regression models, results of the null model, and an image showing social networks containing the 3 waves of recruitment.The CONSORT-eHEALTH checklist (V 1.6.1). | PMC10337306 |
Abbreviations | DISEASE | Center for Disease Control and Preventionmen who have sex with menmultivariate-adjusted odds ratiorandomized controlled trialsocial network strategysexually transmitted infectionunprotected anal intercourseJoint United Nations Programme on HIV/AIDS | PMC10337306 | |
Data Availabilty | The data sets generated during or analyzed during this study are available from the corresponding author on reasonable request. | PMC10337306 | ||
Key Points | PMC10701610 | |||
Question | ASCVD, CKD, chronic kidney disease | ATHEROSCLEROTIC CARDIOVASCULAR DISEASE, EVENTS, ASCVD | Among adults older than 65 years with chronic kidney disease (CKD) stages 3 to 4 and no history of atherosclerotic cardiovascular disease (ASCVD), is new statin use associated with lower risk of mortality or major adverse cardiovascular events (MACE)? | PMC10701610 |
Findings | In this cohort study of 14 828 participants, a target trial emulation of statin initiation found that statins were significantly associated with a 9% lower risk of all-cause mortality. There was a numerically lower risk of MACE, but the results were not statistically significant. | PMC10701610 | ||
Meaning | CKD, chronic kidney disease | EVENTS, ASCVD | These findings suggest that in older adults with CKD stages 3 to 4 without prior ASCVD, statin initiation may lower risk of mortality and MACE.This cohort study uses target trail emulation to evaluate the association of statin use with all-cause mortality and major adverse cardiovascular events among US veterans older than 65 years with chronic kidney disease stages 3 to 4. | PMC10701610 |
Importance | death, ASCVD, CKD, chronic kidney disease | ATHEROSCLEROTIC CARDIOVASCULAR DISEASE, ASCVD | There are limited data for the utility of statins for primary prevention of atherosclerotic cardiovascular disease (ASCVD) and death in adults with chronic kidney disease (CKD). | PMC10701610 |
Objective | CKD | EVENTS | To evaluate the association of statin use with all-cause mortality and major adverse cardiovascular events (MACE) among US veterans older than 65 years with CKD stages 3 to 4. | PMC10701610 |
Design, Setting, and Participants | CKD | ASCVD | This cohort study used a target trial emulation design for statin initiation among veterans with moderate CKD (stages 3 or 4) using nested trials with a propensity weighting approach. Linked Veterans Affairs (VA) Healthcare System, Medicare, and Medicaid data were used. This study considered veterans newly diagnosed with moderate CKD between 2005 and 2015 in the VA, with follow-up through December 31, 2017. Veterans were older than 65 years, within 5 years of CKD diagnosis, had no prior ASCVD or statin use, and had at least 1 clinical visit in the year prior to trial baseline. Eligibility criteria were assessed for each nested trial, and Cox proportional hazards models with bootstrapping were run. Analysis was conducted from July 2021 to October 2023. | PMC10701610 |
Exposure | Statin initiation vs none. | PMC10701610 | ||
Main Outcomes and Measures | stroke | STROKE, SECONDARY, MYOCARDIAL INFARCTION, TRANSIENT ISCHEMIC ATTACK | Primary outcome was all-cause mortality; secondary outcome was time to first MACE (myocardial infarction, transient ischemic attack, stroke, revascularization, or mortality). | PMC10701610 |
Results | CKD | Included in the analysis were 14 828 veterans. Mean (SD) age at CKD diagnosis was 76.9 (8.2) years, 14 616 (99%) were men, 10 539 (72%) White, and 2568 (17%) Black. After expanding to person-trials and assessing eligibility at each baseline, there were 151 243 person-trials (14 685 individuals) of nonstatin initiators and 2924 person-trials (2924 individuals) of statin initiators included. Propensity score adjustment via overlap weighting with nonparametric bootstrapping resulted in covariate balance, with mean (SD) follow-up of 3.6 (2.7) years. The hazard ratio for all-cause mortality was 0.91 (95% CI, 0.85-0.97) comparing statin initiators to noninitiators. The hazard ratio for MACE was 0.96 (95% CI, 0.91-1.02). Results remained consistent in prespecified subgroup analyses. | PMC10701610 | |
Conclusions and Relevance | CKD | ASCVD | In this target trial emulation of statin initiation in US veterans older than 65 years with CKD stages 3 to 4 and no prior ASCVD, statin initiation was significantly associated with a lower risk of all-cause mortality but not MACE. Results should be confirmed in a randomized clinical trial. | PMC10701610 |
Introduction | death, ASCVD, CKD, chronic kidney disease | ATHEROSCLEROTIC CARDIOVASCULAR DISEASE, ASCVD | Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of death among older adults with chronic kidney disease (CKD).While some evidence supports statin use for primary prevention of ASCVD in patients with moderate CKD, few older adults were included in clinical trials, | PMC10701610 |
Methods | PMC10701610 | |||
Ethics | This study was approved, and the requirement for obtaining patient informed consent was waived due to its retrospective nature, by the VA Boston institutional review board. This study followed the Strengthening the Reporting of Observational Studies in Epidemiology ( | PMC10701610 | ||
Target Trial Specification | The first step of the target trial emulation framework is to specify the hypothetical pragmatic trial protocol that would be used to address the question of interest. | PMC10701610 | ||
Specification and Emulation of Target Trials Evaluating Statin Therapy Initiation Effectiveness on Mortality Following Diagnosis of Stage 3 or 4 CKD Using Observational Data From VA Electronic Health Records, January 1, 2005, to December 31, 2017 | TIA, death, CKD, chronic kidney disease, Dialysis or stage 5, stroke, ASCVD, End-stage heart failure, dementia, Active liver disease, peripheral artery disease, andCKD stage | MYOCARDIAL INFARCTION, PERIPHERAL ARTERY DISEASE, TRANSIENT ISCHEMIC ATTACK, HYPERLIPIDEMIA, STROKE, CANCER, DISEASE, RHABDOMYOLYSIS, SENSITIVITY, SECONDARY, CKD STAGE 5, ATHEROSCLEROTIC CARDIOVASCULAR DISEASE, PERIPHERAL VASCULAR DISEASE, TYPE 2 DIABETES, ASCVD, TIA | Aged >65 y with a first diagnosis of stage 3 or 4 CKD between January 1, 2005, and September 30, 2015, inclusive.No prior diagnosis of ASCVD including myocardial infarction, coronary revascularization, transient ischemic attack, stroke, peripheral vascular disease, or peripheral artery disease at baseline.No prior exposure to statins before baseline.User of VA health care system within one year prior to baseline.No enrollment in hospice.Known body mass index within 1 year of baseline.No contraindications for statin therapy:Dialysis or stage 5 CKD,Rhabdomyolysis,Active liver disease,End-stage heart failure,Active chemotherapy, radiation indicating active cancer, andEnd-stage dementia.Same as for the target trial, except:Considered key criteria based on Initiation of a new statin therapy at baseline orNo statin therapy initiation at baseline.Same as for the target trial, except:Initiation defined by receipt or fill of any statin ≥30 d supply at baseline.Individuals randomly assigned to a treatment strategy at baseline. Individuals and their treating physicians are aware of assigned treatment.Patients were classified according to the treatment assignment that is compatible with the observed data at baseline. Randomization was emulated by adjusting for baseline covariates.Risk of death (all-cause mortality) over the follow-up period. Secondary outcome of MACE or death considered.Same as for the target trial.Follow-up starts at baseline and goes until death, outcome (specific to analysis), or the end of the study period (December 31, 2017), whichever happens first.Same as for the target trial.Intention-to-treat effect, ie, initiation of treatment.Observational analogue of the intention-to-treat effect, or the prescription and fill of statin therapy within the data sources available.Intention-to-treat analysis, Cox proportional hazards model to estimate the relative risks of outcome between treatment groups.Sensitivity analyses considered by entire analytic process to the following subgroups by:Age (66-74 and ≥75 y).Sex (male and female),Race (White, Black, and other),Cardiovascular disease risk (high and low),Frailty (frail and nonfrail),Prevalent type 2 diabetes (yes and no),Code for hyperlipidemia, andCKD stage (3 and 4).Same as intention-to-treat analysis, except that patients may be enrolled in multiple person-trials for statistical efficiency and confidence bounds estimated using non-parametric bootstrapping. To adjust for imbalance in baseline confounders, propensity score overlap weighting was used.Sensitivity analyses conducted, in full, within the trials corresponding to each subgroup.Abbreviations: ASCVD, atherosclerotic cardiovascular disease; CKD, chronic kidney disease; Other race includes American Indian or Alaska Native, Asian, and Native Hawaiian or Pacific Islander individuals.Baseline, or time zero, would be defined as the date of randomization to initiating or not initiating statins. Only person-trials within the first 5 years following CKD diagnosis would be considered, and individuals who progressed to CKD stage 5 or requiring dialysis would be excluded, as these are considered contraindications for statin initiation. Those in the treatment group, or statin initiators, would receive at least one 30-day supply of a statin at the time of randomization. Those randomized to noninitiation would not receive any statins at the time of randomization, and both the clinician and patient would be aware of treatment assignment.The outcome for the target trial would be ascertained as the first date of death or end of study, whichever occurs first. In an analysis for secondary outcomes of MACE, the outcome would include any occurrence of MI, TIA, stroke, coronary revascularization, or death during follow-up. Time to MACE outcome would be measured as the first occurrence of a MACE, and follow-up would end at this date or end of study, whichever comes first.In a target trial study of statin initiation, the intention-to-treat analysis would include those who filled a statin prescription at baseline, while inclusion in the per-protocol analysis would be based on the patient’s adherence to taking the medication as directed.We additionally would conduct the following subgroup analyses by stratifying on key factors: age (66-74 vs ≥75 years), sex, race (Black or African American, White, other [American Indian or Alaska Native, Asian, or Native Hawaiian or Pacific Islander], vs unknown), specific CKD stage (3 vs 4), risk of ASCVD, frailty, and prevalent type 2 diabetes and hyperlipidemia. | PMC10701610 |
Target Trial Emulation | TIA, stroke, ASCVD, PVD | STROKE, PVD, CKD STAGE 3, ASCVD, TIA | To emulate the previously described target trial, we used a nested trials design with data from the VA Corporate Data Warehouse (CDW)To be considered regular VA users, individual person-trials were assessed for at least 1 clinical visit at VA in the prior year, as measured by a record in the outpatient domain or having a weight measurement in the vitals domain (for calculation of BMI). CKD stage 3 or 4 was identified by at least 1 inpatient or 2 outpatient diagnoses, defined by Veterans with a CKD stage 3 or 4 diagnosis entered the cohort, and their index date was assigned as soon as they had been either a user in VA for a full year or turned 66 years. Patients with any statin use or diagnosis of ASCVD at any time prior to the index date were excluded. ASCVD was defined as a history of MI, TIA, stroke, PVD, or coronary revascularization using a previously published algorithm. | PMC10701610 |
Exposure and Outcomes | We identified statin prescriptions using their US generic and trade names and adjudicated drug names in VA pharmacy and CMS records. | PMC10701610 | ||
Variables | Age, sex, and race | PMC10701610 | ||
Statistical Analysis | Frailty, CKD | For the hypothetical trial, we would try to randomize individuals such that all factors that could possibly affect the outcome would be balanced between the treatment groups. In the emulation setting, there is the potential for confounding by indication, thus we used propensity score weighting methods to ensure the treatment groups, conditional on these confounders, would be exchangeable at baseline. Variables used in the propensity score calculation included age, sex, race, BMI, smoking status (current vs former or never), blood pressure medications (yes vs no), nonstatin prescriptions (yes vs no), polypharmacy (yes vs no), comorbidities as listed previously (yes vs no for each), specific CKD stage (3 vs 4), Frailty Index,We used overlap weighting to minimize the influence of extreme propensity scores on the model output.As a final sensitivity analysis, we considered a new user design, assuming eligibility assessment at CKD diagnosis and selecting the first eligible baseline for each treatment and individual, ie, 1 row for statin initiators at time of statin initiation and 1 row for each eligible individual at index or date of initial CKD diagnosis.All analyses were conducted in SAS Enterprise Guide version 8.3 (SAS Institute). Two-sided | PMC10701610 | |
Baseline Characteristics of Eligible Person-Trials in the Target Trial Emulation of Statin Initiation for the Prevention of All-Cause Mortality and Major Adverse Cardiovascular Events Among US Veterans Older Than 65 Years Free of ASCVD, Diagnosed With Moderate CKD, 2005 to 2015 | Frailty, CKD, chronic kidney disease, COPD | CHRONIC OBSTRUCTIVE PULMONARY DISEASE, COPD, ATHEROSCLEROTIC CARDIOVASCULAR DISEASE, HEART, ASCVD | Abbreviations: AHA, American Heart Association; ACC, American College of Cardiology; ASCVD, atherosclerotic cardiovascular disease; BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); CKD, chronic kidney disease; COPD, chronic obstructive pulmonary disease; eGFR, estimated glomerular filtration rate.The Frailty Index’s range is 0 to 1, with higher scores indicating worse frailty. | PMC10701610 |
Association of Statin Initiation and Risks of All-Cause Mortality and MACE in Eligible Person-trials of US Veterans Older Than 65 Years With Moderate CKD Diagnosis in the Previous 5 Years Between 2005 and 2017 | stroke, death, CKD, chronic kidney disease | STROKE, EVENT, MYOCARDIAL INFARCTION, TRANSIENT ISCHEMIC ATTACK | Abbreviations: CKD, chronic kidney disease; HR, hazard ratio; MACE, major adverse cardiovascular event.Confidence intervals computed using 500 nonparametric bootstrap resamples.Time to first transient ischemic attack or stroke, myocardial infarction, revascularization, or death. | PMC10701610 |
Association Between Statin Initiation and All-Cause Mortality in US Veterans Older Than 65 Years and Free of Atherosclerotic Cardiovascular Disease (ASCVD) With Stage 3 or 4 Chronic Kidney Disease (CKD) | HEART | Other race includes Asian or Pacific Islander or Hawaiian or American Indian or Alaska Native. AHA indicates American Heart Association; HR, hazard ratio. | PMC10701610 | |
Secondary Outcome | Over the follow-up period there were a total of 57 722 MACEs: 988 (34%) and 56 734 (38%) among statin initiator vs noninitiator person-trials. After propensity score overlap weighting, statin initiation had 4% lower risk of MACE (hazard ratio, 0.96; 95% CI, 0.91-1.02), but the results were not statistically significant ( | PMC10701610 | ||
Association Between Statin Initiation and Major Adverse Cardiovascular Events in US Veterans Older Than 65 Years and Free of Atherosclerotic Cardiovascular Disease (ASCVD), With Stage 3 to 4 Chronic Kidney Disease (CKD) | HEART | Other race includes Asian or Pacific Islander or Hawaiian or American Indian or Alaska Native. AHA indicates American Heart Association; HR, hazard ratio. | PMC10701610 | |
Sensitivity Analysis: New User Design | deaths, CKD | CVD, EVENTS | When the study was expanded to include all 16 694 eligible veterans older than 65 years, free of CVD, and with a new diagnosis of CKD 3 or 4, there were 6931 deaths and 8199 MACE events. After propensity score overlap weighting was applied, the hazard ratio for mortality was 0.68 (95% CI, 0.62-0.76) and for MACE was 0.84 (95% CI, 0.76-0.92) (eTable in | PMC10701610 |
Discussion | nondialysis CKD, ASCVD, CKD, cardiovascular disease | CARDIOVASCULAR DISEASE, EVENT, EVENTS, KIDNEY DISEASE, ASCVD | In this target trial emulation of statin initiation in US veterans older than 65 years with CKD stages 3 to 4 and no prior ASCVD, statin initiation was associated with a lower risk of all-cause mortality but not with MACE. In a less restrictive analysis that included all eligible veterans, results suggested a greater protective association for statins with both all-cause mortality and MACE. These results call into question the growing movement to deprescribe statins for primary prevention in older adults with CKD.Current Kidney Disease Improving Global Outcomes guidelines recommend initiation of statins in older patients with moderate CKD due to the established risk of ASCVD in this population.Our study supports prior literature on the role of statins for primary ASCVD prevention in CKD.Additional post hoc analyses of primary prevention trials focusing on individuals with nondialysis CKD have been mixed. One reported no statistically significant mortality benefit for statins at any stage of CKD,Chronologic age is established as the strongest nonmodifiable risk factor for ASCVD. Coupled with the hyperinflammatory state of CKD,Our study specifically assessed the role of age in addition to CKD level when considering statins for primary prevention. Results were consistent for every age group. The decision to prescribe is multifactorial, and these data support the use of statins for primary prevention for any older adult with CKD.Clinical trials, such as the Statins in Reducing Events in the Elderly (STAREE)This study has several strengths. Our data included linked electronic health record, clinical, and claims data with more than a decade of follow up. Using this large data set, we were able to focus on the role of statins for primary prevention among older adults with CKD stages 3 to 4, a population typically underrepresented in clinical trials. An adequate event rate was ensured due to the overall greater burden of cardiovascular disease among our population of veterans compared with the general population. | PMC10701610 |
Limitations | This study has several limitations. First, this is a study of US veterans who are predominantly male and White. As a result, our findings may not be generalizable to other populations. Second, there may be residual unmeasured confounding due to the nature of administrative claims data, despite the target trial emulation and propensity score methods. Third, we did not evaluate the per-protocol effect size for statin use after the initial prescription, although we have previously shown that most individuals prescribed a first statin continue to fill prescriptions for statins over time. | PMC10701610 | ||
Conclusions | CKD | ASCVD | Among US veterans older than 65 years with CKD stages 3 to 4 and no prior ASCVD, statin initiation was associated with a lower risk of all-cause mortality compared with no statin initiation. Results should be confirmed in a randomized clinical trial. However, until such trials are completed, these data argue against withholding or deprescribing statins for primary prevention in older patients with CKD stages 3 to 4. | PMC10701610 |
Background | hand pain, peripheral nerve disease, numbness, CTS | PERIPHERAL NERVE DISEASE, CARPAL TUNNEL SYNDROME, ENTRAPMENT NEUROPATHY | Carpal tunnel syndrome (CTS) is a prevalent entrapment neuropathy resulting in hand pain, numbness and/or weakness, which significantly impairs hand function in daily activities. Repetitive peripheral magnetic stimulation (rPMS) is a potential therapeutic option for focal peripheral nerve disease and may be beneficial for CTS treatment. We aimed to compare the effects of rPMS and conventional therapy in the management of CTS. | PMC10200096 |
Methods | Carpal Tunnel, CTS | DISEASE PROGRESSION | A blinded assessor randomly assigned 24 participants with electrodiagnostically-confirmed mild or moderate CTS to either rPMS or conventional therapy. Both groups were briefed on disease progression and tendon-gliding exercises. In the intervention group, the rPMS protocol, five sessions of rPMS—with a frequency of 10 Hz, 10 pulses/train, and 100 trains/session—were performed over a period of 2 weeks, with three sessions in the first week and two sessions in the second week. At baseline and the end of the second week, the Boston Carpal Tunnel Questionnaire, pinch strength, and electrodiagnostic results were evaluated. | PMC10200096 |
Results | The rPMS group demonstrated significantly greater within-group improvement in symptom severity scores (2.3 | PMC10200096 | ||
Conclusions | Five sessions of rPMS resulted in significant reduction in symptom severity, improvement in pinch strength and increase in SNAP amplitude. Future research should investigate the clinical utility of rPMS using a larger sample and longer treatment and follow-up durations. | PMC10200096 | ||
Introduction | painless, CTS | CARPAL TUNNEL SYNDROME, ENTRAPMENT NEUROPATHIES, ENTRAPMENT NEUROPATHY | Carpal tunnel syndrome (CTS) is an entrapment neuropathy of the median nerve at the wrist that accounts for 90% of all entrapment neuropathies (Treatment of CTS consists of either surgical or non-surgical management. Generally, surgical treatment is reserved for patients with severe symptoms (Repetitive peripheral magnetic stimulation (rPMS) is a relatively painless, non-invasive and well-tolerated therapy. rPMS emits magnetic field-induced electrical pulses that stimulate sensorimotor nerve fibers and muscle fiber mechanoreceptors ( | PMC10200096 |
Materials and Methods | carpal tunnel syndrome, TCTR | CARPAL TUNNEL SYNDROME, MAY | This research was reviewed and approved by the Khon Kaen University Ethics Committee (Ref. HE 621319) and was registered in August 2020 with the Thai Clinical trials registry (TCTR 20200828002). The research was conducted in accordance with the principles of the Helsinki Declaration. The study was an assessor-blinded pilot randomized controlled trial. From September 2020 to May 2021, we enrolled patients with mild to moderate carpal tunnel syndrome who visited our outpatient clinic. Before inclusion, each participant received a thorough explanation of the study protocol and provided written informed consent. Our inclusion criteria were: age at least 18 years and mild to moderate symptom severity. According to electrodiagnostic criteria ( | PMC10200096 |
Sample size considerations | For pilot studies, it is recommended that each group contain at least 12 participants ( | PMC10200096 | ||
Procedures | Participants were randomly assigned by computer randomization to either conventional therapy or to the rPMS group in a block-of-four design. The nursing assistant, who was not responsible for the allocations, informed the responsible physician about the treatment allocation. The control group ( | PMC10200096 | ||
Set-up of rPMS therapy. | PMC10200096 | |||
Outcome measures | CTS | A blinded assessor performed the outcome measurements. The control and rPMS groups were evaluated at the end of the second week. If patients had bilateral CTS, the intervention and evaluation were performed on the side with the more severe involvement, as determined by electrodiagnosis results. | PMC10200096 | |
Primary outcome | CTS | Baseline data regarding CTS symptoms were collected | PMC10200096 | |
Secondary outcomes | Hand pinch strength was evaluated using pinch gauges at an elbow flexion of 90 degrees. Three tests were conducted, and the mean was reported in pounds (lbs) (Median nerve electrodiagnostic measurement was performed at a room temperature of 32 °C using Medtronic Keypoint G4 (Natus Medical Incorporated, Pleasanton, CA, USA). Median motor nerve recording was done using a surface-recording electrode placed on the abductor pollicis brevis (APB) muscle. The stimulating electrode was placed 8 cm from the active electrode at the APB muscle on the median nerve between the palmaris longus tendon, flexor carpi radialis tendon and elbow. We recorded the onset latency and compound muscle action potential (CMAP) amplitude. In addition, antidromic sensory nerve conduction studies evoked at the wrist were recorded from the middle finger: in this case, the stimulating electrode was first positioned 14 cm away from the active electrode which was around the proximal phalanx, and then at the elbow. A minimum of 20 sensory nerve action potentials were averaged. In addition, the peak latency and sensory nerve action potential (SNAP) amplitude were recorded. If the CMAP amplitude was less than 5 mV or there was no response, electromyography (EMG) was performed. | PMC10200096 | ||
Statistical analysis | REGRESSION | Continuous data are presented by mean and standard deviation for normally distributed data. Median and interquartile ranges are presented in non-normally distributed data. We conducted intention to treat analysis and missing data were addressed using multiple imputation. Paired t-tests were used to compare pre- and post-treatment within-group outcomes. We used a multiple linear regression model to determine difference between groups, with follow-up values as dependent variables ( | PMC10200096 | |
Results | CTS | Twenty-four participants were enrolled. They were divided into two groups of 12. The rPMS group’s age was 49.7 ± 10.4 years (mean ± standard deviation), and most were female (11/12 = 91.7%). In the control group, the age was 52.3 ± 7.2 years, and eight (66.7%) were female. The respective median duration of working time in the rPMS and control groups was 8 and 7 hours/day. The median duration of CTS symptoms in both groups was 3.5 months ( | PMC10200096 | |
Baseline characteristics of participants ( |
Data are reported as | PMC10200096 | ||
Flow diagram of the study. | Only the rPMS group demonstrated significant improvement in symptom severity scores (SSS) determined by the Thai version of the Boston Questionnaire (2.3 | PMC10200096 | ||
Severity of CTS pre and post-treatment in the rPMS and control groups. |
Marginal homogeneity test. | PMC10200096 | ||
Discussion | peripheral nerve injuries, hand pain, pain, CTS | PMS | The purpose of the study was to compare the therapeutic effects of five sessions of repetitive Peripheral Magnetic Stimulation (rPMS) PMS creates a magnetic field that induces an electrical current flow that improves sensory and motor nerve fiber function, which may explain improved symptoms and hand function. rPMS is a novel treatment method and growing evidence suggests that it may be an effective treatment option for treating CTS or other peripheral nerve injuries. rPMS parameters for pain relief and restoration of sensorimotor nerve function vary from 600 to 4,500 pulses (In the PMS group, pinch strength was improved from 10.6 to 13.8 lbs. This finding agrees with previous studies. After rPMS treatment, there was a significant improvement in symptom severity scores (SSS) as measured by the Thai version of the Boston Questionnaire. In accordance with the findings of Although the improvement in DSL in the rPMS group was not significant, the increase in SNAP amplitude was. Previous research on CTS treatment trended to concentrate on distal motor and sensory latency (DML and DSL) parameters, but not SNAP amplitude. For instance, a recent meta-analysis revealed that therapeutic ultrasound in CTS significantly improved DML with a mean effect size of 0.09 ms (Although there was no significant difference between the severity category of the two treatment groups, the rPMS group appeared to have better results than the control group, as two out of 12 participants (16.7%) changed from mild or moderate CTS to normal electrophysiologic findings. If the conversion rate remains high in a study with a larger sample size, rPMS would be a promising treatment for CTS.This research has several limitations. First, the duration of treatment was brief, so the long-term effect is unknown. Second, patients in the rPMS group reported improved hand pain | PMC10200096 |
Conclusions | Five sessions of rPMS resulted in significant improvements in symptom severity, pinch strength, and neurophysiological parameters; however, there was no significant positive effect of rPMS when comparing all outcomes between the two groups. Future research should investigate the clinical utility of rPMS using a larger population sample and a longer treatment and follow-up. | PMC10200096 | ||
Supplemental Information | PMC10200096 | |||
Raw data. | Click here for additional data file. | PMC10200096 | ||
Consort checklist. | Click here for additional data file. | PMC10200096 | ||
Trial registry number and protocol. | Click here for additional data file.We thank Miss Jitjira Chaiyarit, Clinical Epidemiology Unit, for biostatistical consultation and Mr. Bryan Roderick Hamman—under the aegis of the Publication Clinic, Khon Kaen University, Thailand—for assistance with the English-language presentation of the manuscript. | PMC10200096 | ||
Additional Information and Declarations | PMC10200096 | |||
Competing Interests | The authors declare that they have no competing interests. | PMC10200096 | ||
Human Ethics | The following information was supplied relating to ethical approvals (Khon Kaen University Ethics Committee granted Ethical approval to carry out the study within its facilities (Ethical approval reference: HE 621319). | PMC10200096 | ||
Data Availability | The following information was supplied regarding data availability:The raw data are available in the | PMC10200096 | ||
Clinical Trial Registration | TCTR | The following information was supplied regarding Clinical Trial registration:TCTR 20200828002 | PMC10200096 | |
References | PMC10200096 | |||
Background | Providing individualized care based on the context and preferences of the patient is important. Knowledge on both prognostic risk stratification and blended eHealth care in musculoskeletal conditions is increasing and seems promising. Stratification can be used to match patients to the most optimal content and intensity of treatment as well as mode of treatment delivery (i.e. face-to-face or blended with eHealth). However, research on the integration of stratified and blended eHealth care with corresponding matched treatment options for patients with neck and/or shoulder complaints is lacking. | PMC9996840 | ||
Methods | This study was a mixed methods study comprising the development of matched treatment options, followed by an evaluation of the feasibility of the developed Stratified Blended Physiotherapy approach. In the first phase, three focus groups with physiotherapists and physiotherapy experts were conducted. The second phase investigated the feasibility (i.e. satisfaction, usability and experiences) of the Stratified Blended Physiotherapy approach for both physiotherapists and patients in a multicenter single-arm convergent parallel mixed methods feasibility study. | PMC9996840 | ||
Results | pain | In the first phase, matched treatment options were developed for six patient subgroups. Recommendations for content and intensity of physiotherapy were matched to the patient’s risk of persistent disabling pain (using the Keele STarT MSK Tool: low/medium/high risk). In addition, selection of mode of treatment delivery was matched to the patient’s suitability for blended care (using the Dutch Blended Physiotherapy Checklist: yes/no). A paper-based workbook and e-Exercise app modules were developed as two different mode of treatment delivery options, to support physiotherapists. Feasibility was evaluated in the second phase. Physiotherapists and patients were mildly satisfied with the new approach. Usability of the physiotherapist dashboard to set up the e-Exercise app was considered ‘OK’ by physiotherapists. Patients considered the e-Exercise app to be of ‘best imaginable’ usability. The paper-based workbook was not used. | PMC9996840 | |
Conclusion | Results of the focus groups led to the development of matched treatment options. Results of the feasibility study showed experiences with integrating stratified and blended eHealth care and have informed amendments to the Stratified Blended Physiotherapy approach for patients with neck and/or shoulder complaints ready to use within a future cluster randomized trial. | PMC9996840 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12891-023-06272-6. | PMC9996840 | ||
Keywords | PMC9996840 | |||
Background | MSK pain, disability, shoulder complaints, pain | Musculoskeletal (MSK) pain conditions are substantial contributors to global disability [To guide physiotherapists in achieving patient-centered care, stratified care is one possible approach [A first approach to stratified care in patients with neck and shoulder complaints is to match content and intensity of physiotherapy treatment to the patient’s risk of persistent disabling pain, using the Keele STarT MSK Tool [A second approach to individualize care is to match the mode of physiotherapy treatment delivery to the patient’s suitability for blended treatment. With the introduction of new technologies within physiotherapy, generally two modes of delivery of physiotherapy treatment can be distinguished: a traditional treatment consisting of face to face physiotherapy guidance, and a blended treatment in which physiotherapy sessions are integrated with technology such as a smartphone application to help patients manage their MSK pain independently, in the home environment [Despite tools being available to identify patients’ (i) risk of persistent disabling pain (Keele STarT MSK Tool) and (ii) suitability for blended physiotherapy care, no study has yet combined these approaches to individualize primary care nor developed suitable matched treatments for each patient subgroup. Therefore, this study aimed to: (1) develop physiotherapy-specific matched treatment options as part of a new Stratified Blended Physiotherapy approach for patients with neck and/or shoulder complaints that matches the values of end-users; and (2) investigate feasibility of the Stratified Blended Physiotherapy approach for patients with neck and/or shoulder complaints prior to determining its effectiveness in a future cluster randomized trial [ | PMC9996840 | |
Methods | PMC9996840 | |||
Study design | This study was a two phase, mixed methods study comprising first the development of matched treatment options, followed by evaluating feasibility of the developed Stratified Blended Physiotherapy approach. | PMC9996840 | ||
Phase 1 - development of matched treatment options | The first phase comprised the development of physiotherapy-specific matched treatment options. To support the agreement about matched treatment options, three focus groups were conducted. An exploratory, descriptive phenomenological approach was used, with thematic analyses. | PMC9996840 | ||
Phase 2 - feasibility of the stratified blended physiotherapy approach | The second phase investigated the feasibility of the developed Stratified Blended Physiotherapy approach for patients with neck and/or shoulder complaints. Feasibility was evaluated in a multicenter single-arm convergent parallel mixed methods study. Both quantitative and qualitative data were collected independently and analyzed in parallel. These quantitative and qualitative results were compared to look for patterns and contradictions to identify possible improvements to the Stratified Blended Physiotherapy approach. | PMC9996840 | ||
Participants | PMC9996840 | |||
Phase 1 - development of matched treatment options | Twenty-five stakeholders with expertise in the field of eHealth, stratified care and neck and/or shoulder complaints were invited to one of three focus groups, including physiotherapists, researchers, eHealth entrepreneurs, teachers and physiotherapy policy officers. All stakeholders had a background in physiotherapy. Participants were identified from the authors’ professional networks, and invited by email. | PMC9996840 | ||
Phase 2 - feasibility of the stratified blended physiotherapy approach | biceps tendinosis, fracture, MSK pain, rupture, shoulder instability, trauma | SYSTEMIC DISEASE, SUBACROMIAL PAIN SYNDROME |
Twenty-eight physiotherapists working in primary care were invited to participate in the feasibility study. These physiotherapists were also from the authors’ professional network, and were different to those in the first phase. Physiotherapists were eligible to participate if they treated at least four new patients with neck and/or shoulder complaints per month.
Patients with sufficient mastery of the Dutch language were eligible for participation if they had experience of subacromial pain syndrome, biceps tendinosis, shoulder instability or non-specific MSK pain of the neck and/or shoulder (not caused by acute trauma (fracture or rupture) or by systemic disease) [ | PMC9996840 |
Data collection | PMC9996840 | |||
Phase 1 - development of matched treatment options | Pain | Three focus groups were conducted in September and October 2018. The focus groups were facilitated by authors CK and MvT and lasted approximately one hour. In all three focus groups, a facilitator provided a study overview and a brief overview of a similar recently developed blended intervention for a different patient group (e-Exercise Low Back Pain [ | PMC9996840 | |
Phase 2 - feasibility of the stratified blended physiotherapy approach | ’ | RECRUITMENT, RECRUITMENT | Participating physiotherapists received a four-hour training session on how to integrate the Stratified Blended Physiotherapy approach into their daily practice and the study procedures. Physiotherapists were asked to aim for the inclusion of at least two patients. Recruitment of patients for the feasibility study lasted from April 2019 until June 2019. During the initial registration, eligible patients were verbally informed about the study and invited to participate in the data collection by the participating physiotherapy practice secretariat. Every potentially eligible patient who was not invited by the physiotherapy practice secretariat, was invited by participating physiotherapists. If the patient agreed to participate in the data collection, contact details were sent to the researcher via a secure messenger service. Thereafter, the researcher sent an information letter to the patient by email. Subsequently, the researcher contacted the patient by phone to check whether the patient read an understood the information letter. If so, the researcher screened the eligibility criteria. After informing the participant about the study and the assessment of their eligibility, an informed consent form was sent to the participant by mail. After consenting to participate, the patient was asked to send the signed informed consent form back to the research team. An extra screening of the eligibility criteria was performed by the physiotherapist during the first physiotherapy session.
A digital questionnaire was sent to the patients three months after the first physiotherapy session. There was no maximum number of patients that could be included per physiotherapist. Physiotherapists received a questionnaire at the end of the patient recruitment period. Quantitative data collection in the feasibility study consisted of three measures:
Patients’ satisfaction with treatment was measured with the Global Perceived Effect – Dutch Version scale (GPE-DV) [Whether a patient received a smartphone app or paper-based workbook and subsequently patient willingness to recommend either the smartphone app or paper-based workbook was evaluated using the Net Promoter Score (NPS) [Patients’ experienced usability of the smartphone app and physiotherapists’ experienced usability of the physiotherapist dashboard was evaluated with the System Usability Scale (SUS) [
Qualitative data collection consisted of semi-structured interviews with both patients and physiotherapists. All physiotherapists and patients were consecutively invited by e-mail to participate in a semi-structured interview. Semi-structured interviews were held after patients completed the intervention. An exploratory, descriptive phenomenological approach was used, with thematic analyses [ | PMC9996840 |
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