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References
PMC10470147
Key Points
PMC9941970
Question
INFLUENZA
What is the incremental effectiveness of providing a parent short message service (SMS) reminder nudge in addition to a clinician nudge alone (control) for children and adolescents with special risk medical conditions to improve influenza vaccine receipt?
PMC9941970
Findings
In this randomized clinical trial of 600 children and adolescents, a parent SMS reminder nudge increased vaccination uptake.
PMC9941970
Meaning
INFLUENZA
Results suggest that parent-clinician nudges are more effective for optimizing influenza vaccine receipt than clinician nudges alone.
PMC9941970
Importance
INFLUENZA
Children with chronic medical conditions are at increased risk of severe influenza. Uptake of influenza vaccination in children and adolescents with these identified special risk medical conditions (SRMCs) is suboptimal.
PMC9941970
Objective
INFLUENZA
To assess the effectiveness of Flutext-4U, a parent short message service (SMS) reminder nudge intervention, in increasing influenza immunization in children and adolescents with SRMCs.
PMC9941970
Design, Setting, and Participants
INFLUENZA
This randomized clinical trial was conducted at a tertiary pediatric hospital in Adelaide, South Australia, from April 15 to September 30, 2021. Children and adolescents aged 6 months to younger than 18 years with SRMCs and a subspecialist outpatient appointment over a 5-month period during the Australian seasonal infl...
PMC9941970
Interventions
Participants were randomly assigned (1:1 ratio) to control: clinician nudges (hospital vaccine availability, ease of access, and recommendation from hospital subspecialists) or SMS intervention (control conditions plus an additional SMS reminder nudge to parents), with randomization stratified by age group (<5 years, 5...
PMC9941970
Main Outcomes and Measures
INFLUENZA
The primary outcome was influenza vaccination, as confirmed by the Australian Immunisation Register.
PMC9941970
Results
INFLUENZA
A total of 600 participants (intervention group: 298 [49.7%]; mean [SD] age, 11.5 [4.6] years; 162 female participants [54.4%]; control group: 302 [50.3%]; mean [SD] age, 11.4 [4.7] years; 155 female participants [51.3%]) were included. Influenza vaccination was 38.6% (113 of 293) in the SMS intervention group compared...
PMC9941970
Conclusions and Relevance
INFLUENZA
Results of this randomized clinical trial suggest that an additional SMS reminder nudge for parents delivered in the tertiary care hospital setting to children and adolescents with SMRCs resulted in higher influenza vaccine uptake compared with clinician nudges alone.
PMC9941970
Trial Registration
ANZCTR Identifier:
PMC9941970
Introduction
death
INFLUENZA
Children and adolescents with special risk medical conditions (SRMCs) are a priority group for influenza immunization because of their increased risk of influenza-associated hospitalization, intensive care admission, mechanical ventilation, and death.Many reasons for low influenza immunization rates in children with SR...
PMC9941970
Methods
PMC9941970
Study Design
INFLUENZA
This was a parallel-group randomized clinical trial (RCT) conducted from April 15 to September 30, 2021, of the SMS intervention on receipt of influenza vaccine in children with SRMCs. The trial was approved by the Women’s and Children’s Health Network (WCHN) human research ethics committee, with a waiver of informed c...
PMC9941970
Study Location
The study was conducted at the Women’s and Children’s Hospital (WCH), 1 of 3 public pediatric and obstetric hospitals across metropolitan Adelaide, South Australia. The 295-bed hospital is the jurisdiction’s leading provider of specialist care for children; it includes care for all the pediatric specialties and has the...
PMC9941970
Participants
PMC9941970
Inclusion Criteria
Children and adolescents (aged 6 months to <18 years) with SRMCs were identified from the WCH’s outpatient department appointment lists. Eligibility screening was completed by pediatric specialists using criteria set out in the National Immunisation Program
PMC9941970
Randomization and Blinding
An independent statistician (not otherwise involved in the trial) prepared the randomization schedule. Parents were randomly assigned to study arm in a 1:1 ratio using ralloc.ado, version 3.7.6 in Stata, version 16 (StataCorp). Allocations were performed using randomly permuted blocks of size 4, stratified by child age...
PMC9941970
Control
INFLUENZA
In the control arm, influenza vaccine signage was placed around the hospital, and vaccine availability and ease of access were ensured. Clinician-level nudges comprised influenza vaccine reminder stickers on the front of hard-copy case notes and bookmarks at the relevant clinical notes page. The purpose of these nudges...
PMC9941970
Intervention
MessageMedia
FLU, INFLUENZA
The intervention comprised a parent-level nudge, in addition to clinician nudges. In the parent nudge, SMS reminders were sent to the child’s parent (using MessageMedia software) in a nondirective educational approach advising them that their child/adolescent was eligible for a funded influenza vaccine and that they co...
PMC9941970
Data Collection
INFLUENZA
The study coordinator (K.H.) followed up all study participants. Baseline demographic information were collected for all parent-child pairs including the child’s age, sex, Aboriginal or Torres Strait Islander status, medical specialty, postcode (to determine Index of Relative Socioeconomic Disadvantage and residential ...
PMC9941970
Outcomes
INFLUENZA
The primary outcome was receipt of at least 1 dose of influenza vaccine by September 30, 2021 (the end of the trial period), as confirmed on the AIR. Secondary outcomes were receipt of at least 1 dose of influenza vaccine during the optimal period (April 1-June 30) among children randomly assigned on or before June 15,...
PMC9941970
Sample Size
We planned to enroll at least 540 parents of children with SRMCs at the WCH. To have 80% power to detect a clinically meaningful 30% relative increase in the percentage of children vaccinated from 40% in the clinician-level (control) to 52% in the SMS intervention group, a sample size of 270 children per group was requ...
PMC9941970
Statistical Analysis
All analyses were undertaken on a modified intention-to-treat basis according to the statistical analysis plan, prespecified prior to database lock (
PMC9941970
Results
ADVERSE EVENTS, RECRUITMENT, INFLUENZA
Overall, 2831 children were screened for the trial; 2212 were deemed ineligible including prior receipt of influenza vaccine before study start, leaving 619 who were randomly assigned to the intervention and control groups. After randomization, 19 participants were excluded because they had already received the 2021 in...
PMC9941970
Baseline Characteristics of Trial Participants by Randomized Arm
Abbreviations: IRSD, Index of Relative Socioeconomic Disadvantage; SMS, short message service.
PMC9941970
Consolidated Standards of Reporting Trials (CONSORT) Flowchart
The per-protocol analysis included 293 participants from the control group and 283 participants from the short message service (SMS) intervention group (parents of children aged ≥0.5 and <18 years). AIR indicates Australian Immunisation Register.
PMC9941970
Influenza Vaccine Receipt
INFLUENZA
Influenza vaccination increased from 26.2% (79 of 302) in the control group to 38.6% (113 of 293) with the SMS intervention (adjusted OR [aOR], 1.79; 95% CI, 1.27-2.55;
PMC9941970
Effect of Intervention vs Control on Probability of Receiving Influenza Vaccine in 2021
REGRESSION, INFLUENZA
Abbreviation: OR, odds ratio.Adjusted for categorical child age group (<5, 5-14, >14 years).Risk difference derived from logistic regression model using standardization, with 95% CIs calculated using bootstrapping.Influenza vaccine receipt until September 30, 2021.Optimal period (defined as April 1-June 30) is restrict...
PMC9941970
Kaplan-Meier Estimates of Time to Influenza Vaccine Receipt
SMS indicates short message service.
PMC9941970
Parent Acceptability
INFLUENZA
A parent survey was completed by 242 of 600 participants (response rate of 40.3%). Respondents’ children were more likely to have received the 2021 influenza vaccine according to the AIR compared with overall trial participants (106 of 242 [43.8%] vs 192 of 595 [32.7%]). Parents were more likely to overreport their chi...
PMC9941970
Discussion
INFLUENZA
Results of this RCT suggest that a parent SMS nudge delivered in the context of tertiary care to children and adolescents with SRMCs increased influenza vaccine receipt. The SMS nudge intervention resulted in a more timely influenza vaccine receipt and during the optimal seasonal influenza period. This is an important ...
PMC9941970
Strengths and Limitations
In addition to the wavier of consent and RCT design, the strengths of our trial included high follow-up rates and clinician-level elements that can be implemented by most health care services. A trial limitation was the inability to implement an additional nudge in the form of a reminder letter to GPs (primary care–lev...
PMC9941970
Conclusions
INFLUENZA
Results of this RCT suggest that the addition of parent SMS nudge reminders delivered in the context of tertiary care to children and adolescents with SRMCs was superior to clinician nudges alone. This resulted in higher vaccine receipt in the optimal seasonal influenza period.
PMC9941970
Background
hemorrhoids
HEMORRHOIDS
Despite the benefits attributed to the use of local anesthesia (LA) for open hemorrhoidectomy (OH) in developed countries, this technique is still not considered as the first line technique in low-income countries such as Uganda; therefore, we aimed at comparing the cost of OH under LA versus Saddle block among patient...
PMC10666347
Methods
hemorrhoids
MAY, HEMORRHOIDS
This trial was conducted from December 2021 to May 2022 among patients with primary uncomplicated 3rd or 4th degree hemorrhoids. The operating time, and direct costs in (US$) including medical and non-medical were recorded. We analysed the cost in the two groups (local anesthesia versus saddle block) using SPSS version...
PMC10666347
Results
Findings of fifty-eight patients were analysed including 29 participants per group. There was a significant difference in operating time and cost among the two groups (p < 0.05). The mean operating time was 15.52 ± 5.34(SD) minutes versus 33.72 ± 11.54 min for OH under LA and SB respectively. The mean cost of OH under ...
PMC10666347
Conclusion
The use of local anesthesia for OH was found to have less operating time with high-cost effectiveness. Being affordable, local anesthesia can help to increase the turnover of patients who would otherwise wait for the availability of anesthesia provider. Policy makers should emphasize its applicability in low-income set...
PMC10666347
Trial registration
Pan African Clinical Trials Registry, PACTR202110667430356. Registered on 08/10/2021.
PMC10666347
Keywords
PMC10666347
Background
hemorrhoid, pain
HEMORRHOID, COMPLICATION
Open hemorrhoidectomy (OH) (Milligan and Morgan technique) has remained the standard of hemorrhoid surgery worldwide [The major problem in performing hemorrhoidectomy under LA is the pain that occurs during injection of the local anesthetic through the sensitive anoderm [The costs of anesthetic procedures have become a...
PMC10666347
Methods
hemorrhoids
HEMORRHOIDS
This cost benefit analysis is part of a randomized controlled trial that aimed at comparing outcome of open hemorrhoidectomy using local anesthesia versus saddle block among patients with primary uncomplicated 3rd or 4th degree hemorrhoids in Western Uganda; thus, part of the methodology has been previously described [
PMC10666347
Study design
This study was an economic evaluation by cost-benefit analysis from a double-blind randomized controlled trial, conducted in the departments of surgery at Kampala International University-Teaching Hospital (KIU-TH), Kitagata and Adventist Hospital in Western Uganda. The study was approved by the KIU local ethics commit...
PMC10666347
Study population and sample size determination
hemorrhoids
HEMORRHOIDS
Fifty-eight patients with uncomplicated 3rd or 4th degree hemorrhoids were randomized from 1st October 2021 to 2nd June 2022 to undergo OH either under local anesthesia (group A) or the saddle block (group B); (29 patients per group). Detailed methodology including patient selection, sample size determination and analy...
PMC10666347
Cost calculation
During this trial, we considered direct costs, including both medical and non-medical for all patients who underwent OH in the two groups. The materials used during and after open hemorrhoidectomy in both groups such as surgical blades, gloves, drugs among others, and the anesthetic fees were considered as medical dire...
PMC10666347
Data analysis
Data was statistically analysed using IBM Statistics SPSS for Windows 23.0. Quantitative data on direct, indirect, and total costs were presented as mean with standard deviation (SD). The mean operative time and standard deviation were computed for each technique of open hemorrhoidectomy. The difference in means was co...
PMC10666347
Results
PMC10666347
Overview of the findings
RECRUITMENT
The Consolidated Standards of Reporting Trials (CONSORT) diagram for patients’ recruitment is shown in the figure below. All participants (58) were randomized and followed up to day 7 post OH. The cost analysis was done without any missing data (Fig.  Consolidated standards of reporting trials flow diagram
PMC10666347
Operating time and cost analysis for open hemorrhoidectomy
Of the 58 patients included in this trial, 29 participants per group of anesthesia were considered. The operating time and hospital stay were significantly shorter in group A compared to group B (p < 0.001). The cost of OH was significantly lower in group A compared to group B (p = 0.04) (Table  Operating time and cost...
PMC10666347
Bottom-up charge technique for OH under LA versus OH under SB
The Table  ( Mean cost related to open hemorrhoidectomy by bottom-up charge technique per patient per group (Surgical blades, sutures, etc.) (Anesthesia fee, anesthetic drugs, and spine needle) (Antibiotics, analgesics, and fluids) (Gloves, syringes, canulation, urinary catheter, etc.) (Hospital stay cost, nursing care...
PMC10666347
Discussion
hemorrhoids
HEMORRHOIDS
In our cost-analysis comparison of OH under LA versus SB among patients with 3rd or 4th degree hemorrhoids at three major hospitals in rural Western Uganda, we found that the operating time was greater for SB compared to LA. This is contrary to findings of Younes et al. in Egypt [The use of local anesthesia has been sh...
PMC10666347
Study strengths and limitations
This trial had some limitations but also considerable strengths. In terms of limitations, the use of bottom-up technique for cost analysis of the two techniques was the major limitation in this study and this was due to lack of a standardized locally available price reference tool in the country for open haemorrhoidect...
PMC10666347
Acknowledgements
Not applicable.
PMC10666347
Authors’ contributions
RS, XFO
FKS was the principal investigator, conceived and designed the survey and critically reviewed the manuscript. SMK collected data. RS, XFO, BM, HL, SMK, JM, SFM, GNB, MAW, SMK, MML, BPK, BMV, JBM, AK and PK reviewed the manuscript development, revised the methodology and critically reviewed the manuscript. All authors r...
PMC10666347
Funding
Author FKS was supported by Safe Surgery in DRC (SS-DRC). The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
PMC10666347
Data Availability
The datasets used and/or analysed during the current study is available from the corresponding author on reasonable request.
PMC10666347
Declarations
PMC10666347
Ethics approval and consent to participate
This clinical trial was approved by Kampala International University Research Ethics Committee (KIU-REC) under reference number (KIU-REC-2021-24). Written informed consent was obtained from all the participants prior enrollment. All methods were carried out in accordance with relevant guidelines and regulations.
PMC10666347
Consent for publication
Not applicable.
PMC10666347
Competing interests
Authors declare no competing interest.
PMC10666347
References
PMC10666347
Purpose
RECTAL CANCER
To evaluate the pathological complete response (pCR) rate of locally advanced rectal cancer (LARC) after adaptive high-dose neoadjuvant chemoradiation (CRT) based on
PMC9816267
Methods
The primary endpoint was the pCR rate. Secondary endpoints were the predictive value of
PMC9816267
Results
acute radiation-induced toxicity
Eighteen patients (13 males, 5 females; median age 55 years [range, 41–77 years]) were enrolled in the trial. Patients underwent surgical resection at 8–9 weeks after the end of neoadjuvant CRT. No patient showed grade > 1 acute radiation-induced toxicity. Seven patients (38.8%) had
PMC9816267
Conclusions
Our results showed that a dose escalation on a reduced target in the final phase of CRT is well tolerated and able to provide a high pCR rate.
PMC9816267
Keywords
DEL
Open access funding provided by Università Cattolica del Sacro Cuore within the CRUI-CARE Agreement.
PMC9816267
Material and methods
PMC9816267
Study design and aims
This was a prospective phase II study approved by the local ethics committee and registered in an international public registry (NCT03479814). All patients enrolled in the study signed an informed consent.The primary aim was to assess the pCR rate after Flow chart of the study
PMC9816267
Eligibility criteria
tumor, skin cancer
TUMOR, CARDIOVASCULAR DISEASE, NEOPLASMS, METASTATIC DISEASE, SKIN CANCER, CERVICAL CARCINOMA, ONCOLOGY
Inclusion criteria were biopsy proven LARC with cT3-4N0-2M0 (any tumor site) or T2N1-2 M0 (only lower rectum) stage; age ≥ 18 years; Eastern Cooperative Oncology Group performance status ≤ 2; adequate hematological count and liver/renal function. Exclusion criteria were as follows: patients unfit for chemotherapy or su...
PMC9816267
Outcome measures
tumor, liver and renal function
TUMOR
At baseline, a clinical evaluation based on rectal examination and complete clinical history was performed. Subsequent assessments included colonoscopy with biopsy, routine blood tests with carcino-embryonic antigen (CEA), liver and renal function, trans-rectal ultrasound (TRUS), contrast-enhanced thorax-abdomen-pelvis...
PMC9816267
Radiotherapy planning
All patients were immobilised with full bladder in supine position using the Combifix™ frame and underwent a baseline
PMC9816267
PET-CT analysis and target volumes definition
All Two weeks after CRT start, an interim CTV definition
PMC9816267
Image analysis and interpretation criteria
The following metabolic
PMC9816267
Organs at risk (OARs)
The following OARs were considered: bowel (defined as the “bowel bag”), bladder, and femoral heads. The acceptability of dose distribution to the OaRs was evaluated based on the dose/volume constraints suggested by the quantitative analysis of normal tissue effects in the clinic (QUANTEC) guidelines [
PMC9816267
Intensity-modulated RT (IMRT)
IMRT was delivered using an Elekta Sinergy Linac (Elekta, Crowley, United Kingdom), equipped with standard multi leaf collimators, with 6–15 MV photon energy. During the first phase of CRT (IMRT-SIB on PTV1 and PTV2), a daily online check of the set-up was performed using an electronic portal imaging device, as previou...
PMC9816267
Chemotherapy
Concurrent chemotherapy was based on capecitabine (825 mg/m
PMC9816267
Surgery
Surgery was scheduled about eight weeks after the end of the CRT. The total mesorectal excision with pelvic autonomic nerve preservation was performed when technically feasible. However, the choice among surgical approaches (abdomino-perineal resection or low anterior resection) was based on physical examination and th...
PMC9816267
Follow-up
toxicity, death
ADVERSE EVENT, RECURRENCE
The first follow-up visit included physical examination and full blood count and was performed 4 weeks after surgery. Chest CT scan and abdominal-pelvic CT scan or MRI were performed every 6 months in the first 5 years and yearly thereafter. Local control was calculated from the date of diagnosis to the time of local–r...
PMC9816267
Sample size and statistical analysis
According to the Simon’s optimal two-stage design [
PMC9816267
Funding
DEL
Open access funding provided by Università Cattolica del Sacro Cuore within the CRUI-CARE Agreement.
PMC9816267
Declarations
PMC9816267
Ethical approval
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
PMC9816267
Conflict of interest
The authors declare no competing interests.
PMC9816267
References
PMC9816267
Introduction
Doctor et al
PMC9856831
Methods
death
REGRESSION
This randomized clinical trial was preregistered at ClinicalTrials.gov (Clinicians were included if they had prescribed an opioid within the 12 months before a patient’s death from July 1, 2015, to June 30, 2016. We analyzed 12 months of data before and after the intervention. We evaluated the change in total weekly MM...
PMC9856831
Results
We excluded clinicians who were no longer practicing at follow-up, eliminating 19 prescribers and 1 corresponding decedent (
PMC9856831
Study Flowchart
CURES indicates Controlled Substance Utilization Review and Evaluation System; ME, medical examiner.
PMC9856831
Adjusted Per-Prescriber Weekly MMEs After Intervention
Abbreviation: MME, morphine milligram equivalent.The difference in differences was –24.56 MMEs (95% CI, –34.19 to –14.71 MMEs).The difference in differences was –9.24 MMEs (95% CI, –14.00 to –4.39 MMEs).
PMC9856831
Discussion
death, overdose
This randomized clinical trial found that opioid prescribing continued to decrease well after receipt of a letter notifying the clinician of a fatal overdose. Awareness of being observed, an injunction from authority, and the availability of harm may explain this effect. The intervention was delivered at a low cost. Th...
PMC9856831
References
Trial Protocol Click here for additional data file. Data Sharing Statement Click here for additional data file.
PMC9856831
Purpose
SLEEP-DISORDERED BREATHING
In a cohort, observational prospective trial, we assessed the long-term dynamics of sleep-disordered breathing in patients with resistant hypertension after renal denervation and their association with blood pressure change at remote follow-up.
PMC10668416
Materials and methods
hypertension
HYPERTENSION
Twenty-eight patients with stable hypertension who were recruited for endovascular radiofrequency renal denervation in 2012–2019 and had valid both baseline and follow-up sleep study, were included in the analysis. All patients underwent physical examination, anthropometry, office and ambulatory blood pressure measurem...
PMC10668416
Results
apnea-hypopnea
SLEEP APNEA
The average follow-up comprised 30.1 ± 8.4 months. At long-term follow-up, no significant changes in creatinine level, estimated glomerular filtration rate, body mass index were registered. There was a significant increase in sleep apnea severity indices: the mean change in apnea-hypopnea index comprised 9.0(-21.1;25.2...
PMC10668416
Conclusions
hypertension
SLEEP APNEA, HYPERTENSION
Although the severity of sleep apnea worsens at > 12 months follow-up after renal denervation, this is not associated with hypertension exaggeration.
PMC10668416
Supplementary Information
The online version contains supplementary material available at 10.1186/s12890-023-02757-1.
PMC10668416
Keywords
PMC10668416
Introduction
hypopneas, HTN, hypoxia, ventricular arrhythmias, OSA, arousals, hypercapnia, SDB
SLEEP-DISORDERED BREATHING, VENTRICULAR ARRHYTHMIA, HYPOXIA, HTN, COLLAPSE, OBSTRUCTIVE SLEEP APNEA
Obstructive sleep apnea (OSA) characterized by the repetitive episodes of upper airway complete (apneas) or partial (hypopneas) collapse during sleep, is the most common type of sleep-disordered breathing (SDB) [Activation of sympathetic nervous system resulting from intermittent hypoxia and hypercapnia, altered chemor...
PMC10668416