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Strengths and Limitations
ADVERSE EVENTS, RECRUITMENT
Strengths of the study included multicountry representation from a diversity of clinical settings, good per protocol intervention completion rates (83% NICU MT, 60% postdischarge MT), high study retention rates (95%), and use of a wide array of psychometrically strong measurement tools. Lack of adverse events or longer...
PMC10220519
Conclusions
In this RCT, parent-led, infant-directed singing facilitated by a music therapist did not have clinically important effects on parental mental health or infant development. Parent-led music therapy supported by a music therapist was safe and well-accepted by parents. Building on qualitative findings
PMC10220519
Objectives
JIA, genicular nerve block, pain
JUVENILE IDIOPATHIC ARTHRITIS, UNILATERAL KNEE ARTHRITIS
This study aimed at evaluating the effect of genicular nerve block (GNB) in juvenile idiopathic arthritis (JIA) patients with persistent unilateral knee arthritis on pain, inflammatory parameters, function, and range of motion.
PMC9935707
Methods
JIA, Swelling, tenderness, pain
UNILATERAL KNEE ARTHRITIS, RHEUMATISM
A total of 104 JIA patients were diagnosed according to the International League Against Rheumatism (ILAR) criteria with persistent unilateral knee arthritis. They were allocated randomly into 2 groups: group 1 treated with GNB, while group 2 was treated with intra-articular triamcinolone (TA) only. Visual analogue sca...
PMC9935707
Results
tenderness, PD, swelling, pain
VAS pain, tenderness, swelling, and SOLAR grey scale (GS) and power Doppler (PD) scores were significantly reduced after 2 weeks in both groups (
PMC9935707
Conclusion
inflammation, JIA, pain
INFLAMMATION
GNB was able to control pain and improve function and inflammation of the knee joint in JIA patients. Though steroid attained better results after 2 weeks, GNB achieved an equivalent longer-term improvement after 12 weeks.
PMC9935707
Keywords
Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB).
PMC9935707
Introduction
rheumatoid arthritis, JIA, mono-articular knee arthritis, fracture, pain, osteopenia, hemiplegic, Chronic recurrent knee arthritis, RA
RHEUMATOID ARTHRITIS, INFLAMMATORY ARTHRITIS, UNILATERAL KNEE ARTHRITIS, INFLAMMATION, DISEASE, OSTEOPENIA, REMISSION, KNEE ARTHRITIS, ADHESION, JOINT INFLAMMATION
JIA is the commonest chronic inflammatory arthritis in children. Its prevalence is 1/1000. It is characterized by a heterogeneous pattern of joint inflammation for at least 6 weeks. Age at onset is usually < 16 years. The clinical presentation, prognosis, and response to treatment are very heterogeneous. The knee, ankl...
PMC9935707
Methods
PMC9935707
Patients
JIA
DISEASE
First, we obtained an ethical committee approval from the faculty of Medicine Al-Azhar University (0000016) and then we recruited JIA patients (no condition for disease duration) diagnosed after ILAR criteria [A total of 198 JIA cases were enrolled in the study. Out of them, 87 cases were excluded either due to the pre...
PMC9935707
Randomization and blinding
Randomization was done using the 1:1 allocation. For every two participants, the first child selected a group number from a box and the following was allocated to the opposite group. Moreover, participants were also blinded for the nature of the injected substance. Clinical evaluation, initial US evaluation, randomizat...
PMC9935707
Study design
Tenderness, Juvenile arthritis disease
HAND SWELLING
Participants were enrolled from the rheumatology clinics in Al-Azhar University Faculty of Medicine. They were monitored at baseline, after 2 weeks, and 12 weeks. The different outcome measures including clinical examination, Lysholm score, SOLAR score, and VAS were assessed in each visit. Juvenile arthritis disease ac...
PMC9935707
GNB
PD
PERIOSTEUM
Participants were asked to sit supine with a pillow supporting the popliteal fossa. The examined part was sterilized, and a 12 MHz linear probe (Toshiba Aplio 400 US system) was arranged. The transducer was turned sagittal at the front of the distal end of the femur. The probe was moved from medial or lateral to detect...
PMC9935707
Intra-articular steroid injection
knee flexion
STERILE, INFILTRATION
The participant was supine, with 30° knee flexion. The probe was directed axially, and the quadriceps tendon was recognized with the suprapatellar recess below. The sterile technique was considered for injection. The needle was introduced from the lateral side to medial one after infiltration anesthesia using 2 ml 1% l...
PMC9935707
Outcome measures
PMC9935707
VAS on pain
pain
VAS for the involved knee was also done at the same intervals. The VAS was mounted from 0 to 10. Grade 0 equals no pain and 10 signifies the worst possible pain [
PMC9935707
Semi-quantitative score for swelling and tenderness
tenderness, swelling, Swelling
Swelling and tenderness were measured using a semi-quantitative score graded from 0 to 3; a score of 0 means no swelling nor tenderness and a score of 3 means maximum swelling and tenderness [
PMC9935707
JADAS-ESR
interphalangeal joints, JIA, active joints, metacarpophalangeal joints
DISEASE
JADAS includes 4 domains: physician global assessment of disease activity (0 means no activity and 10 means maximum activity), parent/patient global assessment of well-being (0 means very well and 10 means very poor), number of active joints, and an inflammatory marker ESR. We used JADAS27 version. The JADAS27 includes...
PMC9935707
Lysholm score
It was used for knee function assessment at 0-, 2-, and 12-week intervals. This questionnaire has 8 subsets. A score between 95 and 100 means excellent functional performance, good 84–94, fair 65–83, and poor < 64 (Fig. Comparison of the outcome between the two study groups:
PMC9935707
SOLAR score
PD, GS
We considered the SOLAR score for sonographic evaluation of the knee in active and control groups at 0-, 2-, and 12-week intervals. A semi-quantitative 0–3 grey GS and PD scores were used. The suprapatellar midline longitudinal scan, medial longitudinal scan, lateral longitudinal scan, and posterior longitudinal scan w...
PMC9935707
Statistical analysis
Quantitative data were expressed as means and standard deviations (SD). We used the Shapiro–Wilk test as numerical means of assessing normality of the quantitative values. Qualitative data were stated as frequencies (No.) and percentages (%). Independent sample Regarding the sample size, we planned a study of a continu...
PMC9935707
Discussion
JIA, active joints, knee arthritis, oligoarticular JIA, capsular calcification, synovitis, arthritis, pain, avascular necrosis, atrophy, ankle arthritis, rheumatoid
KNEE ARTHRITIS, SYNOVITIS, OSTEOARTHRITIS, DISEASE, HYPOPIGMENTATION, ARTHRITIS, OSTEOARTHRITIS KNEE, AVASCULAR NECROSIS, ATROPHY, BLIND, ANKLE ARTHRITIS, DISEASES, COMPLICATIONS
Persistent knee arthritis in JIA was always considered a difficult situation. In many patients, escalating systemic treatment failed to control arthritis. Local therapy was considered a practical alternative, as it can control arthritis without change in systemic treatment plans [It was known that GNB is effective in a...
PMC9935707
Limitations of the study
KNEE ARTHRITIS
The small sample size is considered the chief shortcoming of the study. This can be attributed to the inclusion criteria which emphasized persistent knee arthritis. Gait analysis before and after injection should be considered in the study, but unfortunately, there is no expert for gait analysis in the university. TA h...
PMC9935707
Conclusion
JIA, knee arthritis, knee joints, nerve block
INFLAMMATORY ARTHRITIS, DISEASE, KNEE ARTHRITIS, COMPLICATIONS
GNB could be considered a promising therapy for persistent knee arthritis in JIA patients. It can control disease activity in the knee joints based on different clinical and sonographic outcome measures. Its effect is comparable to intra-articular medications (steroid in particular) with an even better carry-on effect....
PMC9935707
Author contribution
All the authors have read, reviewed, taken part in writing, and approved this trial. The 1st author guaranteed blinding. The 3rd and last authors performed GNB and intra-articular injections. The 2nd, 4th, and 5th authors applied the outcome measures.
PMC9935707
Funding
Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB).
PMC9935707
Data availability
Yes.
PMC9935707
Declarations
PMC9935707
Ethics approval and consent to participate
This study was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice and was approved by the appropriate institutional review boards. Written informed consent to participate in the study was obtained from the patients’ parents or legal guardians.
PMC9935707
Disclosures
None related to the study.
PMC9935707
References
PMC9935707
Background
Physical activity behavioral interventions to change individual-level drivers of activity, like motivation, attitudes, and self-efficacy, are often not sustained beyond the intervention period. Interventions at both environmental and individual levels might facilitate durable change. This community-based study seeks to...
PMC10470135
Methods
The study design is a prospective, cluster randomized controlled trial, with housing developments (
PMC10470135
Discussion
We hypothesize participants living in developments in any of the three intervention groups (E only, I only, and E+I combined) will increase minutes of moderate intensity physical activity more than participants in control group developments. We expect delivery of an intervention package targeting environmental and soci...
PMC10470135
Trial registration
Clinical Trails.gov PRS
PMC10470135
Keywords
PMC10470135
Background
Half of all U.S. adults do not participate in regular physical activity and women consistently report less activity than men [Evidence suggests that characteristics of the environments in which people live can facilitate or inhibit physical activity [On the other end of the spectrum, individual level interventions deli...
PMC10470135
Methods/design
PMC10470135
Participants
The study setting is family-designated public housing developments in the City of Boston managed by the Boston Housing Authority (
PMC10470135
Design of the Community Walks study
SECONDARY, ADVERSE EVENT, EVENT
The design of this study, called Community Walks, is a prospective, cluster randomized controlled trial with housing developments as the unit of randomization. A total of 12 developments (8 managed by Boston Housing Authority and 4 privately managed) will be recruited to participate. Four arms will be compared: environ...
PMC10470135
Formative research
fatigue
From August 2020 to February 2021, we conducted four videoconference meetings with our established community advisory board comprised of Spanish- and English-speaking residents from Boston public housing developments. The first meeting was used to introduce the individual-level telephone physical activity program and a...
PMC10470135
Recruitment – public housing developments and residents
PMC10470135
Recruiting public housing developments
Developments are eligible for selection as one of our study sites if they have at least 100 units. A statistician conducted the randomization stratified by management company (Boston Housing Authority/Private) using a computer program, such that 3 developments went to the E group, 3 developments went to the I group, 3 ...
PMC10470135
Recruitment and screening of the evaluation cohort
RECRUITMENT
We propose to recruit 50 participants per development in the evaluation cohort. Eligibility criteria include being able to speak English or Spanish, being 18 years old or older, being a public housing resident from one of our study sites, not planning to move within the next 2 years, having access to a phone, not curre...
PMC10470135
Intervention overview: role of the HLA
In all intervention developments, community health workers (termed Healthy Living Advocates or HLAs in this program) serve as intervention delivery agents and have been a successful way to partner with public housing communities for engagement activities and clinical trials [
PMC10470135
Intervention overview
PMC10470135
Environmental level intervention: improving the walkability of the public housing development environment
These activities aim to change multiple aspects of the housing development to enable walking as an easy, natural part of life. Our IRB determined that informed consent is not required of people who join environmental-level activities.
PMC10470135
Walking trails and maps
EVENTS, -20
WalkMassachusetts, a non-profit walkability and pedestrian safety advocacy organization serving the Commonwealth of Massachusetts, will mark walking trails surrounding each of the intervention developments with signage indicating walking trail status, duration, directions, and distance. There will be at least one short...
PMC10470135
The process of developing the walking routes
Neighborhood walkability (obtained by assessment using the MAPS tool section 2.7.1) plus feedback from meetings with the managers, local community meetings, and the HLAs with lived experience in these neighborhoods, was used to inform the construction of the walking routes, and subsequent maps created by a professional...
PMC10470135
Structured walking groups
EVENTS, RECRUITMENT
HLAs will organize walking groups and adjust scheduling around work and childcare commitments of participants. Groups will begin meeting twice weekly and will occur more frequently as participation increases. The main recruitment strategies employed for these groups will be from flyers, from tables with posterboard dis...
PMC10470135
Advocacy training meetings
Leaders at WalkMassachusetts will host a 2-session advocacy training meeting at least once per year in each E and E+I development for the HLAs and interested residents. Residents will receive a $25 gift card for attending. The topics covered will be how to: evaluate the walkability of their neighborhood, report issues ...
PMC10470135
Individual level intervention: automated ehealth phone program for physical activity
Phone2Health is based upon a previously tested telephone program designed to increase physical activity among urban African American adults [HLAs will facilitate access to the Phone2Health program for residents who live in developments randomized to receive the I and E+I intervention. The HLAs will obtain verbal inform...
PMC10470135
Combined intervention (environmental plus individual level)
The environmental plus individual intervention combines all activities of the environmental intervention and all activities of the Phone2Health program.
PMC10470135
Environment-level assessments
We will conduct two types of assessments of the built environment at all study public housing developments. First, we will measure access to physical activity resources and walkability at all 12 public housing developments using the Microscale Audit for Pedestrian Streetscapes-abbreviated tool [
PMC10470135
Individual-level measures: evaluation cohort
All eligible and consented participants will be sent a link to complete the surveys; if needed, the Research Assistant will administer surveys in person or over the phone. The Research Assistant will conduct the screening and baseline surveys and will also conduct the follow-up surveys at 12 months and 24 months for ea...
PMC10470135
Primary outcome measurement: physical activity
Our primary outcome is minutes of moderate intensity daily physical activity. Participants will wear an ActiGraph GT3X+ accelerometer-based device on their hip and the device will be initialized to collect raw data at 30 Hz. The participant will be instructed to wear the device during waking hours every day for 7 days,...
PMC10470135
Process measures
EVENT
Process measures will be evaluated to monitor implementation of the intervention and to document receipt of the intervention. The HLAs will fill out a checklist after each physical activity event or promotion activity of the Phone2Health program. This information will help investigators determine intervention dosage an...
PMC10470135
Analysis plan
REGRESSION, SECONDARY
We will “deconstruct” the intervention for the measurement of adherence to the intervention protocol and use these adherence indices in secondary analyses. Adherence data will be collected based on 1) what, how much, and when individual elements were delivered in each development, and 2) what was reported as received b...
PMC10470135
Aim 1 (primary aim)
Hypothesis 1: Participants living in developments in any of the three intervention groups will increase minutes of moderate intensity physical activity more than participants in control group developments at 24 month follow up.
PMC10470135
Within group analysis
Preliminary analysis will examine within group differences in each of the study groups from baseline to the end of the intervention at 2 years. Minutes of moderate or greater intensity activity per week will be examined using paired t-test if the distribution is approximately normal or the nonparametric Wilcoxon signed...
PMC10470135
Between group analysis
REGRESSION
The between group hypothesis is tested in three separate bivariate analyses comparing each intervention group to the control group in two primary outcomes based on the cluster-randomized design. We examine change in each primary outcome pre-intervention to post-intervention: 1) the number of minutes of moderate or grea...
PMC10470135
Statistical analysis
This hypothesis is tested in two separate bivariate analysis - one comparing the multilevel intervention group (E+I) to the environment intervention only group (E) and the other comparing the multilevel intervention group (E+I) to the individual level intervention only group (I).Hypothesis 3: Participants living in dev...
PMC10470135
Statistical analysis
REGRESSION
To examine this hypothesis, we exploit our study design which has a multifactorial design embedded in a cluster randomized controlled trial. Multifactorial experimental designs combine the rigor of experimental design with the ability to produce results on the effectiveness of alternate approaches to multicomponent int...
PMC10470135
Aim 2: mediation/moderation
We will evaluate the mediator effects of motivation, self-efficacy, neighborhood walkability, support from HLAs, and fidelity and moderator effects (i.e., sleep, financial strain, public housing development characteristics, neighborhood social cohesion, and access to physical activity resources) on physical activity be...
PMC10470135
Statistical analysis
Mediation and moderation are examined using variables at both levels, as such we will use multilevel structural equation models and path analysis to examine multilevel mediation and multilevel moderation within and across levels [
PMC10470135
Handling missing data
While the mechanism giving rise to the missing data cannot be determined by the observations, the sensitivity of parameter estimates to missing data assumptions can be studied by fitting multiple models that make different assumptions about the missing data process  [
PMC10470135
Sample size
PMC10470135
Aim 1 - within group analysis sample size
A sample size of 21 achieves 90% power to detect a mean of paired differences of 3.0 with a significance level of 0.05 using a two-sided paired t-test. A sample size of 34 achieves >90% power to detect a difference of 3.0 with a significance level of 0.05 using a two-sided Wilcoxon Signed-Rank test. Assuming at least 2...
PMC10470135
Aim 1 - between group analysis sample size
We power the multivariable analysis based on test for two means in a 2-level hierarchal design with level 2 randomization. Sample sizes of 96 subjects in each group, which were obtained by sampling 3 clusters with an average of 32 subjects per cluster, achieve >90% power to detect a difference between the group means o...
PMC10470135
Aim 2 – mediation
REGRESSION
The test of mediation effect is based on Sobel’s test. A sample size of 395 achieves 90% power to detect a mediation effect of at least 0.04 as measured by the product of two regression coefficients 0.20 (primary predictor) and 0.20 (mediator) when the significance level is 0.05.
PMC10470135
Aim 2 – moderation
PMC10470135
RCP method
A total sample size of 480 observations, were obtained by sampling 3 level-2 units (PHD) in the control group, 3 level-2 units (PHD) in I only group, 3 level-2 units (PHD) in the E only group, and 3 level-2 units (PHD) in the E+I group. Finally, 40 level-1 units (individuals with repeated measurements) were obtained fr...
PMC10470135
LMS method
REGRESSION
A total sample size of 492 level-1 units (individuals), which were obtained by sampling 3 level-2 units (PHD) in the control group, 3 level-2 units (PHD) in I only group, 3 level-2 units (PHD) in the E only group, and 3 level-2 units (PHD) in the E+I group, with an average of 41 level-1 units (individuals) per level-2 ...
PMC10470135
Aim 3 - qualitative interviews
We will conduct qualitative interviews with 40 key informants to explore the future implementation of the multilevel physical activity intervention using the Consolidated Framework for Implementation Research as our conceptual model [Interviewers will follow a semi-structured interview guide with sections corresponding...
PMC10470135
Discussion
The Community Walks study addresses a gap in the literature to test multilevel interventions in low-income populations and is nearly unique in its focus on this population, on a layered multilevel design, and on walking as the main form of physical activity. The environmental level intervention will be delivered by com...
PMC10470135
Trial status
MAY
Protocol Version 1.8, June 7, 2023.Recruitment Start Date: May 2, 2022.Recruitment Approximate End Date: September 4, 2023.
PMC10470135
Acknowledgements
The authors wish to express gratitude to Gianna Fernandez and Charmaine King, Healthy Living Advocates, for their guidance in intervention implementation. This paper is dedicated to the memory of Dr. Deborah Bowen.
PMC10470135
Authors’ contributions
LQ is the Principal Investigator, she conceived the study, led the proposal and protocol development. JD, MG, and SC contributed to the study design and evaluation plan. MA, MS, DR, JM, SM, JK, DC, IS and TW led aspects of program design and development. All authors read and approved the final manuscript.
PMC10470135
Funding
Funding Source: GovernmentFunding Details: NIH/National Institute on Minority Health & Health Disparities (NIMHD), Federal-NIH, Grant, 1R01MD015165.The funding source does not have a role in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript.
PMC10470135
Availability of data and materials
RECRUITMENT
Lisa Quintiliani, Julien Dedier, and Melody Goodman have Access to the final trial dataset. No contractual agreements limit access to dataset. The datasets generated and/or analyzed during the current study are not publicly available due to the research is still ongoing, but are available from the corresponding author ...
PMC10470135
Declarations
PMC10470135
Ethics approval and consent to participate
Boston University, Institutional Review Board (IRB), H-42219.Written, informed consent to participate is obtained from all participants. The research study staff member reviews the informed consent document, discuss risks and possible benefits of study participation, answer any questions that arise, and conclude by ask...
PMC10470135
Consent for publication
Not applicable.
PMC10470135
Competing interests
TW is the President of IEQ Technology, Inc., the company that deployed the Phone2Health program described in this study. All other authors declare that they have no conflicts of interests/competing interests.
PMC10470135
References
PMC10470135
1. Introduction
cancer, CIN
VIRUS, HPV INFECTION, CERVICAL LESIONS, CANCER, DISEASE, CIN, CERVICAL CANCER, CERVICAL CANCER, REGRESSION
In Uganda, the uptake of cervical cancer (CC) screening services is low, at 46.7%, among HIV-infected women, and only 9% of these women adhere to annual CC screening. Some studies have evaluated the possibility of community or home-based human papillomavirus (HPV) self-collected vaginal swabs, but not clinic-based HPV ...
PMC10454402
2. The Health Promotion Model for the Clinic-Based HPV Self-Sampling Approach
DISEASE, SECONDARY, CERVICAL CANCER
The health promotion model (HPM) has been chosen as the conceptual framework to guide this study, because health-promoting behavior is interpreted as a broad conceptualization, including the secondary prevention of CC. The theory could be used to interpret the effectiveness of clinic-based HPV self-sampling, in compari...
PMC10454402
3. Research Implications
PMC10454402
3.1. Study Site
Geographical areas where women have multiple sexual partners are key risk factors for HIV and HPV transmission. Luwero district is found in the central region of Uganda, where 19% of women have multiple sexual partners, which is a key risk factor for HIV and HPV transmission (UDHS, 2016). This provides the basis used t...
PMC10454402
3.2. The Intervention
As shown in
PMC10454402
3.3. The Study Population
The study approach would be to enroll all women attending the HIV clinic aged 25–49 years who had never been screened, had not been screened within the last year (those who had screened for >1 year with normal results), or had abnormal screening results at the clinic, and to obtain their consent to participate.
PMC10454402
3.4. The Phased Approach to Study Implementation
We propose using a phased approach, to allow step-by-step learning, as we implement the study procedures to determine the effectiveness of the clinic-based HPV self-sampling approach. The three phases that would guide this study are detailed below.
PMC10454402
3.4.1. Pilot Phase
RECRUITMENT
To understand the dynamics of testing the tools, randomization, and recruitment procedures, and the specimen collection, handling, transportation, and storage before shipment to the central laboratory, it is important to pilot the tools. A three-day pilot of the tools could be conducted at Mukono General Hospital, Muko...
PMC10454402
3.4.2. Baseline Phase
At baseline, a cross-sectional study design would be used to determine the factors associated with the prevalence of, and those associated with the uptake of, HPV testing in both arms. We could, further, estimate the differences in the viability of the samples between the clinic-based and control groups.
PMC10454402
3.4.3. Effectiveness Phase
SECONDARY, RECRUITMENT
A prospective randomized controlled single-blinded trial has been considered to estimate the efficacy of clinic-based versus home-based HPV self-sampling among HIV-infected women at the HIV clinic. As women came to the HIV clinic, they could prospectively be randomized to clinic-based or home-based HPV self-sampling. T...
PMC10454402
3.5. Recruitment
cancer, CIN, CIN3, Cancer
CANCER, CANCER, CIN
To obtain robust outcomes, all midwives involved in the study would be initially trained in the study procedures. All eligible women attending the HIV clinic would be educated on the different procedures for the collection of samples for HPV testing. Women could prospectively be recruited and randomized as they came to...
PMC10454402
3.6. Sample Size
STIS
It has been estimated that a total of 382 HIV-infected women would determine the effectiveness of the clinic-based HPV sampling approach. In each arm, i.e., the clinic-based and the home-based HPV self-sampling, there would be 191 participants. The required powered sample for this sub-study has been determined based on...
PMC10454402
3.7. Sampling Procedures
An electronic sampling frame of women aged from 25 to 49 years would be obtained via the Luweero district hospital HIV clinic. The women’s history of CC screening could be reviewed in their files. All women who had not been screened at all, not been screened within the last three years, had abnormal screening results, ...
PMC10454402
3.8. Sample Collection Procedures
Those who took up screening in both groups would be educated on the sampling procedure, and given a Qvintip kit to collect their samples. The Qvintip dry-based sample collection kit can be transported at room temperature, and is, therefore, appropriate to use in developing countries, as it does not require cold-chain t...
PMC10454402
3.9. Data Analysis
REGRESSION, EVENTS
To determine the factors associated with the uptake, and HPV prevalence at baseline (0 months) in clinic-based versus home-based HPV self-sampling from the baseline data, descriptive statistics, as well as univariate, bivariate, and multivariate logistic regression would be considered. The difference in uptake over the...
PMC10454402