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Objective
This study examined whether NSE with internet support (NSEIT) and 4 physiotherapy sessions for 12 weeks were noninferior to the same exercises supervised by a physiotherapist twice a week for 12 weeks (NSE).
PMC10337460
Methods
NDI, pain, chronic WAD grade II, Whiplash Disability, neck-related disability
In this multicenter randomized controlled noninferiority trial with masked assessors, we recruited adults aged 18-63 years with chronic WAD grade II (ie, neck pain and clinical musculoskeletal signs) or III (ie, grade II plus neurological signs). Outcomes were measured at baseline and at 3- and 15-month follow-ups. The...
PMC10337460
Results
NDI
Between April 6, 2017, and September 15, 2020, 140 participants were randomly assigned to the NSEIT group (n=70) or the NSE group (n=70); 63 (90%) and 64 (91%), respectively, were followed up at 3 months, and 56 (80%) and 58 (83%), respectively, at 15 months. NSEIT demonstrated noninferiority to NSE in the primary outc...
PMC10337460
Conclusions
chronic WAD grades II
NSEIT was noninferior to NSE in chronic WAD and required less physiotherapist time. NSEIT could be used as a treatment for patients with chronic WAD grades II and III.
PMC10337460
Trial Registration
ClinicalTrials.gov NCT03022812; https://clinicaltrials.gov/ct2/show/NCT03022812
PMC10337460
Introduction
whiplash-associated disorders, WADs
VEHICLE ACCIDENT
A whiplash injury is common after a motor vehicle accident, and many individuals experience chronic and disabling whiplash-associated disorders (WADs) [
PMC10337460
Methods
PMC10337460
Design and Setting
This prospective multicenter randomized controlled trial (RCT) compared 2 groups: NSEIT for 12 weeks with 4 visits to the physiotherapist (NSEIT group) versus supervised NSE twice a week for 12 weeks (NSE group).
PMC10337460
Ethics Approval
The study was approved by the regional ethical review board in Linköping, Sweden (2016/135-31) and followed the Declaration of Helsinki. The study protocol has been published elsewhere [
PMC10337460
Participants and Randomization
dizziness, muscle soreness, headache, pain
ADVERSE EVENTS
Study information was provided to potential participants through reports in newspapers and the media, and individuals interested in participating in the study completed a small web-based survey. An apparently eligible participant was contacted for a telephone interview to further verify their medical history and abilit...
PMC10337460
Interventions
Ventral neck muscle endurance, muscle soreness, neurological pain, pain, increase neck pain, disability
Both interventions are described in The NSEIT group had 4 sessions at the physiotherapy clinic. The first session included a clinical examination and an introduction to the first exercises. In the follow-up sessions (weeks 2, 3, and 7), new exercises were introduced, progressed, and followed up to ensure correct perfor...
PMC10337460
Outcomes
disability, NDI
The outcome measures were reported using questionnaires on Linköping University’s website, Survey and Reports, at baseline and 3 and 15 months after baseline (ie, 12 months after the intervention ended). Ratings on a VAS and Patient-Specific Functional Scale (PSFS) were collected by the test leader. The participants fo...
PMC10337460
Statistical Analysis
SECONDARY
Sample size and power calculations were carried out using PASS (Power Analysis and Sample Size) software (version 13.0.8; NCSS, LLC) based on the primary outcome NDI [The noninferiority tests on primary and secondary outcomes were performed in R (version 3.6.0; R Foundation for Statistical Computing), using the package...
PMC10337460
Patients and the Public
RECRUITMENT
Patients were involved in developing the questionnaires. Before recruitment to the study started, the questionnaires were tested by patients to ensure readability and the inclusion of relevant questions. Patient satisfaction with the exercises, information, tests, and their total experience with the interventions were ...
PMC10337460
Results
PMC10337460
Within-Group Differences
NDI
Within-group differences and the proportion of responders in self-rated recovery are shown in There were no between-group differences in the proportion of responders to treatment (Proportion of responders to treatment at 3- and 15-month follow-up. Data labels above the bar show the absolute number and the total number ...
PMC10337460
Adverse Events
ADVERSE EVENTS, SIDE EFFECTS
No adverse events were reported. Side effects were reported by 31 participants (44%) in the NSEIT group and 39 participants (56%) in the NSE group (
PMC10337460
Discussion
PMC10337460
Principal Findings
decreased disability, disability, chronic WAD, pain
NSEIT was noninferior to NSE, and both groups demonstrated decreased disability and pain, with 47% (23/49)-58% (32/55) of the participants having a sustained clinically important change in disability and a ≥50% reduction in neck pain at the 15-month follow-up. The trial was the first to compare the efficacy of an inter...
PMC10337460
Comparison to Other Studies
chronic WAD grades II, shoulder and lower-limb disorders, pain, neck disability, chronic WAD, neck pain
ADVERSE EVENTS, MUSCULOSKELETAL DISORDERS
The present findings confirm results from other studies showing that an internet-based program may be as good as face-to-face visits in health care [To our knowledge, no studies have investigated if assessment, diagnosis, and the progression of exercises over the internet with or without face-to-face visits can be pref...
PMC10337460
Strengths and Limitations of the Study
WAD
The trial was a multicenter study involving 57 physiotherapists working in primary care clinics in 10 county councils, which enhanced the risk of less control over the delivered interventions. However, the physiotherapists received theoretical and practical training, including written information, and they could contac...
PMC10337460
Conclusion and Clinical Implications
whiplash injuries, chronic WAD grades II, pain, chronic pain, disability, whiplash-associated disorder
ADVERSE EVENTS, CHRONIC PAIN
Both the NSEIT and NSE groups demonstrated sustained clinically important changes in disability and pain for approximately 50% of participants. The results showed that NSEIT was not worse than NSE and could be used as a treatment in patients with chronic WAD grades II and III. The results add to previous studies, offer...
PMC10337460
Abbreviations
disorderWhiplash Disability
Global Rating ScaleNeck Disability Indexneck-specific exerciseneck-specific exercises with internet supportPatient-Specific Functional Scalerandomized controlled trialVisual Analog Scalewhiplash-associated disorderWhiplash Disability Questionnaire
PMC10337460
Data Availability
The data sets generated during this study are available from the corresponding author on reasonable request.
PMC10337460
Background
diabetes
DIABETES
Two polyclinics in Singapore modified systems and trained health professionals to provide person-centred Care and Support Planning (CSP) for people with diabetes within a clinical trial. We aimed to investigate health professionals’ perspectives on CSP to inform future developments.
PMC10585850
Methods
Qualitative research including 23 semi-structured interviews with 13 health professionals and 3 co-ordinators. Interpretive analysis, including considerations of how different understandings, enactments, experiences and evaluative judgements of CSP clustered across health professionals, and potential causal links betwe...
PMC10585850
Results
experiential learning
SAID
Both polyclinic teams introduced CSP and sustained it through COVID-19 disruptions. The first examples health professionals gave of CSP ‘going well’ all involved patients who came prepared, motivated and able to modify behaviours to improve their biomedical markers, but health professionals also said that they only occ...
PMC10585850
Conclusion
Health professionals’ interpretations of CSP, along with their communication skills, interact in complex ways with other features of healthcare systems and diverse patient-circumstance scenarios. They warrant careful attention in efforts to implement and evaluate person-centred support for people with long-term conditi...
PMC10585850
Supplementary Information
The online version contains supplementary material available at 10.1186/s12875-023-02168-5.
PMC10585850
Keywords
PMC10585850
Background
diabetes
DISEASE, CHRONIC DISEASES, DIABETES
Over recent decades, significant efforts have been made internationally to ensure that health services (and especially primary care) support the growing numbers of people with chronic diseases to manage these effectively in the context of their daily lives [The concept of person-centredness is variously explained and i...
PMC10585850
Methods
This was a qualitative, interpretive study. We conducted individual interviews with health professionals working directly with patients for CSP. For context, we also observed the training session for doctors and nurses involved in PACE-D and team huddles convened to support CSP implementation.
PMC10585850
Individual interviews
VAE, confusion, diabetes
DIABETES
All doctors and nurses who conducted CSP conversations for PACE-D were invited to take part, as were PACE-D coordinators (a new teamlet role introduced to help recruit patients, arrange appointments, and collect data for the trial). Eligible staff were identified and approached by a PACE-D administrator and subsequentl...
PMC10585850
Observation of training session and huddles
VAE
SAID
By invitation of PACE-D study leads, and with prior agreement from trainers, VAE was introduced to participating health professionals, as noted above, as one of several observers of the local CSP training session for health professionals and of the first lunchtime huddle sessions convened by the trainers to give the he...
PMC10585850
Results
diabetes
DIABETES
We interviewed 11 doctors, 2 nurses and 3 PACE-D coordinators. 7 doctors and 1 nurse were interviewed twice and 2 PACE-D coordinators asked to be interviewed together, so there were 23 interviews in total. 14 interviews (all in the second wave) were conducted online.Our sample includes all but 2 of the health professio...
PMC10585850
Understandings and reported enactments of CSP
PMC10585850
When CSP goes well: ‘ideal’ patient behaviours and outcomes
When asked early in their interviews for an example in which CSP went relatively well, participants gave strikingly similar responses. In both waves, all included most of the following elements: a patient comes to their CSP conversation actively ‘prepared’ (having read and reflected on their care planning letter), enga...
PMC10585850
Commonality and variation in professional enactments of CSP conversations
Beyond ideas about how patients would ideally engage with CSP, there was much commonality in health professionals’ descriptions of how they conducted CSP conversations and how these compared with pre-PACE-D ‘usual’ consultations and annual reviews. Consistent features included CSP conversations: being allocated more ti...
PMC10585850
Benefits of CSP beyond improvements in health behaviours and biomedical markers
DISEASE
Between them, participants identified various benefits of CSP independent of (but perhaps intermediate to) changes in patients’ health-related behaviours and improvements in biomedical makers. Benefits identified by at least some health professionals included patients: being better informed; feeling less rushed, more l...
PMC10585850
Variations in patients’ ability and willingness to engage
diabetes
DIABETES
Participants reported that many patients did not open or read, let alone reflect and write in care planning letters before their appointments. In the early stages of PACE-D they estimated that up to 30% of patients did not read the letter at all. They reported that this improved after it was agreed that PACE-D coordina...
PMC10585850
Organisational arrangements and policy priorities shaping delivery of CSP
PMC10585850
CSP training, professional huddles and PACE-D coordinator support
Health professionals spoke positively about the CSP training they received and the promise of the approach that it conveyed. Some described starting to use some of the ideas and techniques they learned immediately – before patients had been recruited for PACE-D. There were, however, some challenges associated with the ...
PMC10585850
Appointment scheduling and clinic session pressures
diabetes
MINOR, DIABETES
Both polyclinics scheduled all CSP conversations for two specific weekdays, but routine consultations, including walk-in appointments, were also allocated to these clinic sessions. Some participants found the intermittency of CSP conversations within clinic sessions challenging because they needed to keep switching gea...
PMC10585850
Teamlet working and record systems: challenges to continuity
Patients’ CSP conversation appointments were to a teamlet clinic session, not to a health professional. Teamlets were notionally staffed by two doctors and a nurse, but various leave and secondment arrangements (especially through COVID-19 disruptions) meant multiple health professionals rotated through the teamlets pr...
PMC10585850
A systemic focus on biomedical markers and diabetes
diabetic, diabetes
DIABETES
Although CSP training emphasised working with patients as persons and stressed the value of health professionals attending to patients’ concerns and priorities relating to their diabetes and broader wellbeing, participants were aware that the primary outcome of the PACE-D trial was HbA1c, and that their teamlet and pol...
PMC10585850
Health professionals’ evaluations of CSP
We have seen that health professionals varied in terms of how they interpreted and enacted CSP, including in response to the challenges posed in the polyclinic context. In this section, we examine their broader evaluative judgements.When asked for their overall evaluations of CSP and thoughts about whether CSP should b...
PMC10585850
Discussion
The health professionals who participated in the PACE-D trial have contributed to the implementation of CSP in a busy public sector primary care environment, and they sustained it through COVID-19. This is a significant achievement, especially given the documented pressures of working in Singapore’s polyclinics [The ex...
PMC10585850
Strengths and limitations of methods
In the context of the PACE-D trial, we observed CSP training, interviewed all doctors and nurses who conducted more than a handful of CSPs (half of them twice) and observed a series of professional huddles. We generated a rich dataset that supported detailed examination of both commonality and variation in health profe...
PMC10585850
Contribution to theoretical understanding
diabetes
DISEASE, DIABETES
As briefly noted in Our study supports and enables us to extend this previous work with more attention to temporal and teamworking considerations and the operation of interpretive emphases within complex and value-laden systems of healthcare provision. We develop here an analysis of how the interpretive emphases, value...
PMC10585850
Conclusions
CSP has been implemented and sustained in two busy polyclinics in Singapore. Health professionals’ accounts have illuminated some important challenges and variability of enactments and experiences of CSP. They supported an analysis that highlights the practical significance of health professionals’ interpretations of t...
PMC10585850
Acknowledgements
RECRUITMENT
We are extremely grateful to the health professionals who took part in interviews for this study and allowed observation of their team huddles. We also thank LIM Mui Eng and ANG Shu Lin for supporting the recruitment of health professionals and arrangement of interviews, Monica ASHWINI for arranging transcription and d...
PMC10585850
Authors’ contributions
V.A.E., T.W.Y., E.S.T., V.L. and W.H.T. conceived the study in discussions. V.A.E. conducted the interviews, observed and made field notes from the huddles, led the data analysis and drafted the manuscript. T.W.Y. and V.L. led the professional huddles and provided additional reflections on these. SM contributed to data...
PMC10585850
Funding
VAE
CHRONIC DISEASE
The PACE-D programme is funded by Singapore’s Ministry of Health. This study was funded by the Centre for Chronic Disease Prevention and Management of the National University Health System, Singapore. SM was supported by a Wellcome Trust Institutional Strategic Support Fund flexible returners award (University of Aberd...
PMC10585850
Availability of data and materials
The datasets generated and analysed during the current study are not publicly available due to the agreement made with participants to protect individual professional privacy. They may be available from the corresponding author on reasonable request subject to approval from the Yong Loo Lin School of Medicine, National...
PMC10585850
Declarations
PMC10585850
Ethics approval and consent to participate
Approval for this study was granted by National Healthcare Group Domain Specific Review Board (NHG DSRB Ref 2018/01288) and all methods were performed as stipulated in accordance with the guidelines and regulations. Written informed consent was obtained from all participants prior to the interviews. All study procedure...
PMC10585850
Consent for publication
Not applicable.
PMC10585850
Competing interests
The authors declare no competing interests.
PMC10585850
References
PMC10585850
Abstract
A full list of MRC Unit The Gambia StrepA Study Group members is in the Notes. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.
PMC10547459
Background
Immunity to
PMC10547459
Methods
A post hoc analysis was performed in 320 children randomized to receive LAIV at baseline (LAIV group) or not (control).
PMC10547459
Results
The point prevalence of
PMC10547459
Conclusions
Asymptomatic Understanding natural immunity to Epidemiological observations have demonstrated association between invasive
PMC10547459
METHODS
PMC10547459
Study Population and Design
VIRAL SHEDDING
We conducted a post hoc observational study nested within a randomized controlled trial of LAIV, studying immunogenicity, viral shedding and microbiome interactions in children aged 24–59 months in Sukauta, an urban region of The Gambia. The study (NCT02972957) was conducted over 2 years between February to April 2017,...
PMC10547459
Determination of
Participants had a nasopharyngeal swab taken at day 0 (immediately prior to LAIV receipt), days 7 and 21, using flocked swabs (FLOQSwabs) stored in RNAprotect (Qiagen). Samples were processed within 4 hours of collection and stored at −70°C until further processing. DNA was extracted from 200 μL of RNAprotect using the...
PMC10547459
Antibody Measurement
BLOOD, SEPARATION, INFLUENZA
Blood was collected in serum separation tubes from participants in the LAIV group, for study end points on influenza vaccine immunogenicity [Enzyme-linked immunosorbent assay (ELISA) optimization was performed to determine optimal To measure antibody titers to the additional vaccine antigens group A carbohydrate (GAC) ...
PMC10547459
Statistical Analysis
REGRESSION
All statistical analysis was performed in R (version 4.0.1). Comparison of Samples where optical density measured by ELISA fell below the detection limit of the standard curve, were allocated a random value between zero and the limit of detection. Antibody titers in Luminex data were interpolated using xPonent 4.2 soft...
PMC10547459
RESULTS
PMC10547459
infected skin sores
REGRESSION
A total of 320 participants were included in this study, of which 212 received LAIV ( Data are No. (%).Pearson χTo explore changes in colonization status within an individual over time in all children (n = 320), a generalized logistic mixed effects regression model was used to explore the odds of Factors Associated Wit...
PMC10547459
Serological Responses to
ELISA-quantified serum antibody titers at day 21 in 40/48 colonized participants were compared with those in 61 randomly selected noncolonized participants (all from the LAIV group due to sera availability). Missing serum was due to insufficient remaining material from the parent study. The age was not significantly di...
PMC10547459
DISCUSSION
autoimmunity
AUTOIMMUNITY
In this post hoc study of a randomized controlled trial in The Gambia, we analyzed the impact of LAIV on We also demonstrate that asymptomatic The definition of true Protection following asymptomatic colonization and Our study has several key limitations. Firstly, it was a post hoc analysis of a study that was not des...
PMC10547459
Supplementary Data
PMC10547459
Supplementary Material
Click here for additional data file.
PMC10547459
Notes
Lancefield
INFECTIOUS DISEASES, DISEASES
Presented in part: Lancefield Symposium for Streptococcal and Streptococcal Diseases, Stockholm, 7–10 June 2022 and European Congress of Clinical Microbiology and Infectious Diseases, 9–12 July 2021, Online.For the purpose of open access, the author has applied a CC BY public copyright licence to any Author Accepted ...
PMC10547459
References
PMC10547459
Abstract
Present affiliation: Departamento de Medicina, Dermatología y Toxicología, Unidad de Enfermedades Infecciosas, Hospital Clínico, Universitario de Valladolid, Valladolid, Spain.Members are listed in the Acknowledgements section.
PMC10775153
Background
bacteraemic urinary tract infections
Fosfomycin is a potentially attractive option as step-down therapy for bacteraemic urinary tract infections (BUTI), but available data are scarce. Our objective was to compare the effectiveness and safety of fosfomycin trometamol and other oral drugs as step-down therapy in patients with BUTI due to MDR
PMC10775153
Methods
REGRESSION
Participants in the FOREST trial (comparing IV fosfomycin with ceftriaxone or meropenem for BUTI caused by MDR-Ec in 22 Spanish hospitals from June 2014 to December 2018) who were stepped-down to oral fosfomycin (3 g q48h) or other drugs were included. The primary endpoint was clinical and microbiological cure (CMC) 5–...
PMC10775153
Results
Overall, 61 patients switched to oral fosfomycin trometamol and 47 to other drugs (cefuroxime axetil, 28; amoxicillin/clavulanic acid and trimethoprim/sulfamethoxazole, 7 each; ciprofloxacin, 5) were included. CMC was reached by 48/61 patients (78.7%) treated with fosfomycin trometamol and 38/47 (80.9%) with other drug...
PMC10775153
Conclusions
Fosfomycin trometamol might be a reasonable option as step-down therapy in patients with BUTI due to MDR-Ec but the higher rate of relapses would need further assessment.
PMC10775153
Introduction
Bacteraemic
URINARY TRACT INFECTIONS
Bacteraemic urinary tract infections (BUTI) are frequent, with estimated age-adjusted incidence rates of 20–50 episodes per 100 000 person-years.Fosfomycin remains active against a high proportion of MDR In the FOREST trial, IV fosfomycin was compared with ceftriaxone or meropenem as initial targeted therapy for BUTI d...
PMC10775153
Patients and methods
PMC10775153
Study design and participants
This is a post hoc analysis of the FOREST trial (clinicaltrials.gov identifier: NCT02142751), of which main results were previously published.The study protocol allowed switching to oral therapy according to the treating physician criteria, after a minimum of 4 days of IV treatment if the following conditions were fulf...
PMC10775153
Study variables
bloodstream infection, Sepsis, prostate, pain, dysuria, infection
INFECTION, BLOODSTREAM INFECTION, SEPSIS, PROSTATE
The primary endpoint was clinical and microbiological cure (CMC) at the test of cure (TOC; 5–7 days after finalization of treatment). Clinical cure was defined as resolution of all new signs and symptoms of infection, and microbiological cure (or eradication) as no isolation of the causative Baseline characteristics of...
PMC10775153
Microbiological studies
Bacteria identification and susceptibility testing was performed at local microbiology laboratories using standard techniques. The blood isolates were sent to Hospital Universitario Virgen Macarena, where identification and antimicrobial susceptibility were confirmed using MALDI-TOF and microdilution, respectively, acc...
PMC10775153
Statistical analysis
tenderness, lumbar pain
REGRESSION, SECONDARY
The primary analysis was the difference risk calculated as the absolute difference with two-sided 95% CI in the proportion of patients reaching the primary and secondary endpoints in patients switched to oral therapy with fosfomycin trometamol and to other drugs. Subgroup analyses (according to sex, age groups, fosfomy...
PMC10775153
Results
REGRESSION, EVENTS, SECONDARY
Among the 143 patients included in the modified intention-to-treat population of the FOREST trial, 108 (75.5%) were switched to oral drugs and 35 were not (Figure In order to provide information about the generalizabilty of the results, we compared the 108 patients who were switched to oral drugs with the 35 who were n...
PMC10775153
Discussion
fever, cUTI, infection, bacteraemia, pyelonephritis, febrile UTI
COMPLICATED URINARY TRACT INFECTION, PYELONEPHRITIS, INFECTION, UTI, URINARY TRACT INFECTION
In the FOREST trial, step-down to any oral therapy was used more frequently in patients assigned to IV fosfomycin than in those assigned to IV ceftriaxone or meropenem, which could be explained by differences in reaching the criteria for oral step-down (as seen by differences in reaching early clinical response) and be...
PMC10775153
Supplementary Material
Click here for additional data file.
PMC10775153
Acknowledgements
Canarias
DEL
The Data Safety Monitoring Board of FOREST were formed by Benito Almirante, Mario Fernández and Jose R. Paño-Pardo.Other members of the REIPI-GEIRAS-FOREST group are: Marina De Cueto, Zaira Palacios-Baena, Isabel Morales, Luis Eduardo López-Cortés, Belén Gutiérrez-Gutiérrez, Manuel Camean, Vicente Merino (Hospital Univ...
PMC10775153
Funding
This work was supported by Plan Nacional de I + D + i 2013–2016, Instituto de Salud Carlos III, Ministerio de Ciencia, Innovación y Universidades, co-funded by European Development Regional Fund ‘A way to achieve Europe’, Operative Program Intelligence Growth 2014–2020, via the following grants: PI 13/01282; CIBERINFEC...
PMC10775153
Transparency declarations
EVENTS
P.R.-G. reports receiving honoraria as speaker in lectures from Angelini, Menarini and Shionogi. C.A.-P. reports personal fees from Janssen and Gilead outside the submitted work; J.C.-M. reports personal fees from Astra-Zeneca, non-financial support from Angelini, Pfizer and Gilead, outside the submitted work. V.P. has...
PMC10775153
Author contributions
RECRUITMENT
J.S.-D.: patients’ recruitment, data collection, analysis, manuscript drafting. I.L.-H.: microbiological studies, analysis, critical review of manuscript. A.H.-T.: patients’ recruitment, data collection, critical review of manuscript. P.R.-G.: patients’ recruitment, data collection, critical review of manuscript. E.M.d...
PMC10775153
Supplementary data
Tables
PMC10775153
References
PMC10775153
Abstract
PMC10075285
Background
cancer, death, Cancer
CANCER, CANCER
Cancer is a leading cause of death among people 15–24 years of age. Increasing numbers of cancer patients survive. Extensive cancer therapy may cause wide‐ranging somatic and psychosocial challenges in the lives of the survivors.Research indicates adolescent and young adult cancer (AYA) survivors need to be seen as a d...
PMC10075285
Aims
cancer
CANCER, LENS
Through the theoretical lens of narrative medicine and care ethics, our purpose was to investigate the particular challenges encountered by the AYA cancer survivors, and how they view themselves in light of their illness experiences. We ask how AYA cancer survivors are met and understood by their medical professionals?
PMC10075285