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Measures
PMC10463387
Sociodemographic variables
Demographic variables including age, gender, ethnicity, and social grade were taken using standard UK Office for National Statistics [
PMC10463387
Analysis
self-harm
Descriptive statistics were used to summarise sociodemographic variables. Chi-square was used to compare our sample of people who reported a previous history of self-harm with general population data collected as part of the Adult Psychiatric Morbidity Survey [
PMC10463387
Results
PMC10463387
Sample characteristics
The final sample ( Sample demographics in the two groups (final sample)
PMC10463387
Randomisation check
The success of the randomisation procedure was checked using MANOVA (a flow diagram is presented in Fig.  Flow diagram showing participant allocation to each condition
PMC10463387
Baseline equivalence check
Equivalence between the participants who dropped out versus remained in the study with respect to baseline characteristics was checked using MANOVA. The independent variable was
PMC10463387
Changes in acceptability ratings over time
The proportion of participants scoring at each point on the rating scale of each item at baseline and follow-up is presented in Table  Proportion of responses at each point according to item at baseline and follow-up Two-way repeated measures ANOVAs were used to assess the effect of the two versions of the volitional h...
PMC10463387
Discussion
This paper aimed to operationalise an approach to intervention acceptability that: (a) ensured that a large representative sample of people with lived experience is involved in the process of improving intervention acceptability; and (b) adopted a theory-driven, experimental approach to evaluating whether refining an i...
PMC10463387
Implications
Incorporating participant feedback in the design of interventions is an important stage of intervention development [
PMC10463387
Strengths and limitations
Previous studies applying the TFA to explore intervention development have primarily been qualitative studies [Increasing acceptability is important when developing interventions iteratively, and in line with recognised guidance for intervention development. We present an experimental approach that allows researchers t...
PMC10463387
Conclusions
Incorporating participant feedback is an important consideration for the design, implementation and evaluation of interventions. The Theoretical Framework of Acceptability provides a framework designed to systematically examine the seven components associated with acceptability. Our tool provides a systematic method of...
PMC10463387
Acknowledgements
The authors wish to thank all of the participants involved in this study.
PMC10463387
Authors’ contributions
C.K. and C.J.A. conceived and designed the study. CK led the data anlysis. All authors contributed to the interpretation of the data. C.K. drafted the manuscript. All authors contributed to the manuscript edits and revisions, and approved the final version.
PMC10463387
Funding
This work was funded by the National Institute for Health and Care Research (NIHR) Greater Manchester Patient Safety Translational Research Centre (grant number: PSTRC-2016-003). C.J.A. is supported by the NIHR Manchester Biomedical Research Centre. The views expressed are those of the author(s) and not necessarily tho...
PMC10463387
Data availability
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
PMC10463387
Declarations
PMC10463387
Competing interests
The authors declare no competing interests.
PMC10463387
Ethics approval and consent to participate
Ethical approval was obtained from The University of Manchester Research Ethics Committee (ref: 2020-8446-15312). All methods were performed in accordance with the relevant guidelines and regulations (Declaration of Helsinki). All participants gave informed consent prior to the study.
PMC10463387
Consent for publication
Not applicable.
PMC10463387
References
PMC10463387
Background
osteoporosis, shock
OSTEOPOROSIS, SHOCK
This study aimed to compare the effects of high-intensity laser therapy (HILT) and extracorporeal shock wave therapy (ESWT) in treating consequences of osteoporosis in hemiparetic patients.
PMC10475189
Methods
hemiplegic
OSTEOPOROSIS
A randomized controlled trial was conducted on hemiplegic patients with osteoporosis. They were randomly classified into three equal groups (
PMC10475189
Results
A statistically significant difference (
PMC10475189
Keywords
Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB).
PMC10475189
Introduction
Stroke-related motor disability, Stroke, shock, osteoporotic, pain, fractures, Osteoporosis, osteoporosis
STROKE, SHOCK, COMPLICATIONS, POSTMENOPAUSAL OSTEOPOROSIS, OSTEOPOROSIS, OSTEOPOROSIS
Stroke is one of the most challenging medical conditions in the world. Stroke-related motor disability is leading to miscellaneous complications. Osteoporosis and consequent fractures are well known as stoke-related complications [Hemiparetic patients are predisposed to fractures due to considerable loss of bone mass o...
PMC10475189
Materials and methods
PMC10475189
Study design
A randomized controlled trial was carried out at the Faculty of Physical Therapy Outpatient Clinic, Cairo University, between October 2021 and March 2022. The ethical committee of the Physical Therapy Faculty at Cairo University authorized this work (No: P.T.REC/012/003393). The study was registered as a clinical trial...
PMC10475189
Participants
osteoporosis, osteopenia, hemiplegic
OSTEOPENIA, OSTEOPOROSIS
One hundred and forty hemiplegic patients with osteoporosis of both sexes were chosen randomly. Hemiparetic chronicity ranges from eight to ten years. Their age ranged from 60 to 70 years old. All participants were diagnosed by dual-energy X-ray absorptiometry (DEXA) as osteoporosis or osteopenia, where T-score was − 1...
PMC10475189
Exclusion criteria
RHEUMATOID ARTHRITIS, SKIN DISEASES, MUSCULOSKELETAL DISORDERS
BMI of more than 30 or less than 18, advanced musculoskeletal disorders, rheumatoid arthritis, skin diseases, long-term steroids therapy, or any drug affecting bones.
PMC10475189
Randomization
osteoporosis, hemiplegic
OSTEOPOROSIS
One hundred and forty hemiplegic patients with osteoporosis were evaluated for eligibility; 12 patients disagreed to participate in this study. Therefore, one hundred and twenty-eight were randomly divided into three groups of equal size, using random allocation software (GraphPad Software Inc.) to minimize selection b...
PMC10475189
Outcomes measurements
Osteoporosis, pain
OSTEOPOROSIS, OSTEOPOROSIS
Visual analog scale (VAS): a measurement tool used to evaluate patient discomfort as his/her experience to a specific degreeFall risk assessment: This was performed by two methods: Overall stability index which was obtained by (Biodex Balance Master, USA) the second method was the Short Form of Berg Balance Scale (SFB...
PMC10475189
Therapeutic procedures
PMC10475189
High-intensity laser therapy (HILT)
HIL was produced by ASA S.r.l.—Italy EN 60825, Nd: YAG laser, with an average power of 10.5 W and wavelength of 1064 nm. All the patients in the HIL group received three HILT sessions per week for three months. The lower back and both hips were scanned by the device by 3000 J; the average fluency was 15–10 J cm
PMC10475189
Shock wave therapy
Focused ESWT with 2000 pulses and energy of 0.12 mJ mm
PMC10475189
Power analysis
The sample size was determined using G*Power (version 3.1.9.2; Germany) [F tests-MANOVA: Repeated measures, within-between interaction], using an effect size of 0.135, a 95% power analysis, and a two-sided 5% significant level. As a result, the total estimated sample size for patients was 120 patients.
PMC10475189
Statistical analysis
The statistical analyses were calculated by SPSS version 20. The mean and SD were used to describe the study results. Paired t test was used to compare each group pre and post-intervention. ANOVA was used to compare the three groups’ clinical features and outcome measures before and after the intervention. Qualitative ...
PMC10475189
Discussion
osteonecrosis, stroke, osteoporotic, pain, Osteoporosis, femoral head osteonecrosis, osteoporosis
OSTEONECROSIS, STROKE, NON-UNION FRACTURE, OSTEOPOROSIS, NEOVASCULARIZATION, OSTEOPOROSIS
In order to assess the effectiveness of HILT and ESWT in treating osteoporotic long-term hemiparetic patients, this study was carried out. Outcome measures were visual analog scale (VAS), fall risk which was assessed using two different techniques: the overall stability index (Biodex Balance Master, USA) and the Short ...
PMC10475189
Conclusion
Osteoporosis
OSTEOPOROSIS
According to the current study, combining standard physical therapy with HILT and ESWT has been clinically significant in treating osteoporotic long-term hemiparetic patients, favoring HILT more than ESWT. The visual analog scale (VAS), the Short Form of Berg Balance Scale (SFBBS), and the Quality of Life Questionnaire...
PMC10475189
Acknowledgements
The authors express their respect and appreciation for all participants and for every contribution helped this research
PMC10475189
Author contributions
TIAE and IMAA contributed to data collection; TIAE, IMAA, and AAEMAEH were involved in formal analysis; AAEMAEH, SME, and RMMY contributed to methodology; TIAE, IMAA, and HEO were involved in writing—original draft; and AAEMAEH, SME, RMMY, and HEO contributed to review and editing.
PMC10475189
Funding
Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). This research received no specific grant from any funding agency.
PMC10475189
Availability of data and materials
The data associated with the paper are not publicly available but are available from the corresponding author on reasonable request.
PMC10475189
Declarations
PMC10475189
Ethics approval and consent to participate
The current study’s methods adhered to the 1975 Helsinki Declaration’s ethical principles. The ethical committee of the Physical Therapy Faculty at Cairo University authorized this work (No: P.T.REC/012/003393). Informed consent was obtained from all subjects. All patients received a brief explanation of the examinatio...
PMC10475189
Consent for publication
Not Applicable.
PMC10475189
Competing interests
The authors declare no conflict of interest.
PMC10475189
References
PMC10475189
Supplementary Information
Comorbidity
REGRESSION
Whether patient-reported outcomes (PROs) can predict overall survival (OS) and non-relapse mortality (NRM) among recipients of allogeneic stem cell transplantation (allo-HSCT), is unclear. We performed an exploratory analysis of the prognostic value of patient-reported outcomes (PROs) among 117 recipients of allogeneic...
PMC9998318
Keywords
Open access funding provided by University of Oslo (incl Oslo University Hospital)
PMC9998318
Introduction
toxicity, infections, GVHD, Comorbidity
GRAFT-VERSUS-HOST DISEASE, INFECTIONS, SECONDARY, GVHD, COMPLICATIONS
Patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) have a high risk of transplant-related complications such as toxicity, infections, and graft-versus-host disease (GVHD). Approximately 50% of allo-HSCT recipients become long-term survivors [To predict mortality and transplant-related si...
PMC9998318
Patients and methods
PMC9998318
Approvals
The original RCT and the current study were approved by the Regional Committee for Medical and Health Research Ethics South East Norway (#S-09136c 2009/2115), and the Data Protection Supervisor, Oslo University Hospital and conducted in accordance with the Declaration of Helsinki. All patients gave written informed con...
PMC9998318
Study design and patient selection in the RCT
One hundred and seventeen patients (intervention
PMC9998318
Nutrition intervention in the original randomized controlled trial
In short, the nutritional intervention started upon hospital admission with optimization of energy and protein intake until discharge (usually after 3–5 weeks) [
PMC9998318
Sociodemographic and clinical factors
At enrollment, all the participants provided information on the following sociodemographic factors: age, sex, education, and marital status. The electronic health records were used to provide information on disease-, transplant- and treatment-specific information such as diagnosis, conditioning regime, admission dates,...
PMC9998318
Patient-reported outcomes assessment
Cancer
CANCER
The European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30) was used to assess QoL at baseline (i.e., on day 8 or 7 before allo-HSCT) [
PMC9998318
Clinical scoring systems
DISEASE
Clinical- and transplant-related data were registered daily during hospitalization and later retrieved from the medical health records. This included diagnosis and progression of disease, conditioning regime, donor information, stem cell source, the HCT-CI, and EBMT scores. The HCT-CI score summarizes the presence of 1...
PMC9998318
Statistical analyses
REGRESSION
All descriptive statistics were performed and reported overall and by study group affiliation (intervention and control). Due to the exploratory nature of the current study, we assessed all the scales from the QLQ-C30 questionnaire without selecting any primary scales. For each scale, we used Cox proportional hazard mo...
PMC9998318
Results
PMC9998318
Patient inclusion
In the original RCT, 173 patients ≥ 18 years of age undergoing allo-HSCT with myeloablative conditioning were assessed for eligibility. Of these, 119 patients consented and were randomly assigned to receive the nutrition intervention or the standard total parental nutrition. Two patients in the intervention group were ...
PMC9998318
Univariable analyses for 1-year non-relapse mortality
Univariable analysis on the prognostic significance of the clinical-sociodemographic variables are shown in Supplementary Table
PMC9998318
Discussion
appetite loss, GVHD
APPETITE LOSS, GVHD, COMPLICATIONS, COMPLICATION
Our findings suggest that both the HCT-CI- and the EBMT scores at baseline were prognostic for 1-year OS and for 1-year NRM. None of the PROs from the EORTC QLQ C30 questionnaire remained significant in the multivariable analysis on 1-year OS. Moreover, the analyses suggested that only appetite loss, living alone, and ...
PMC9998318
Acknowledgements
The authors would like to thank all the patients and their families for participating in this study.
PMC9998318
Author contribution
POI
AMG, KJS, MJH, GET, FE, FC, and POI designed this study, analyzed the data, and drafted the manuscript. FE and FC performed the statistical analysis and contributed to the data analysis and data interpretation. All authors critically reviewed the manuscript and approved the final version. The corresponding author had f...
PMC9998318
Funding
Open access funding provided by University of Oslo (incl Oslo University Hospital) The study was supported by Oslo University Hospital, Helse Sør-Øst Trust and the Throne Holst Foundation.
PMC9998318
Data availability
The data that supports the findings of this study are available from the corresponding author on reasonable request.
PMC9998318
Declarations
PMC9998318
Competing interests
FE: had a consultancy or advisory role for AbbVie, Incyte, Janssen, and Syros, outside the submitted work. GET: research grants from Mundipharma and Alexion Pharmaceuticals, advisory board honoraria from Alexion Pharmaceuticals and Janssen-Cilag, and lecture honoraria from Novartis, Janssen-Cilag, Alexion Pharmaceutica...
PMC9998318
References
PMC9998318
Introduction
agoraphobia, agoraphobic, Agoraphobia, anxiety, Anxiety, panic disorder, Panic disorder, panic, F41.0, depression, anxiety-related disorders
DISORDER, EVENT, DISEASE, DISORDERS
The Global Burden of Disease (GBD) estimated that the COVID-19 pandemic has led to a 25.6% increase (95% uncertainty interval (UI): 23.2–28.0) in cases of anxiety disorders worldwide in 2020 [Panic disorder is an anxiety disorder characterized by reoccurring unexpected panic attacks. Agoraphobia refers to avoidance or ...
PMC10313059
Methods
PMC10313059
Original study design
panic disorder, agoraphobia, Anxiety
The aim of the PARADIES cluster randomized trial (cRCT; conducted between 2012 and 2016) was to deliver a low intensity and effective therapy to people with panic disorder with or without agoraphobia in a primary care setting. This cRCT in 73 GPs’ practices included 419 patients with panic disorder with or without agor...
PMC10313059
Present study sample
MAY
For the 60 months follow-up, all patients (N = 419) of the original PARADIES cRCT (conducted between 2012 and 2016) were contacted repeatedly in various ways (telephone, letter, email) from October 2020 to May 2021. The follow-up was completed by 56/230 (24%) patients from 27/36 practices in the IG and 44/189 (23%) pat...
PMC10313059
Flow chart.
PMC10313059
Characteristics of patients.
*Patients’ characteristics of the original study see supplement and original publication [
PMC10313059
Clinical outcomes
Anxiety, anxiety
The severity of anxiety was assessed with the Beck Anxiety Inventory (BAI) [
PMC10313059
Statistical analysis
PMC10313059
A. Cross sectional analysis of the primary and secondary outcome variables at 60 months follow-up
Descriptive analyses of the impact of the intervention on the outcome variables BAI, OASIS, MIA, PHQ-9, PAS A1, PAS A2, fear-of-COVID-19-scale and PACIC were performed with at t-test for independent samples; a p-value smaller than 0.05 meant statistical significance.
PMC10313059
B. Longitudinal analysis: Comparison at baseline, 6 months follow-up and 60 months follow-up
For the comparison of three different measurement dates TAll statistical analyses were carried out with IBM SPSS Statistics, version 28.0.
PMC10313059
Results
PMC10313059
Cross sectional comparison at 60 months follow-up of mean sum scores in anxiety and depression symptoms.
Anxiety, Panic, Agoraphobia, anxiety, panic, depression
CHRONIC ILLNESS
BAI, Beck Anxiety Inventory; MIA, Mobility Inventory, subscale alone; OASIS, Overall Anxiety and Impairment Scale; PACIC, Patient Assessment of Chronic Illness Care; PHQ-9, Patient Health Questionnaire; PAS, Panic and Agoraphobia Scale; SD, Standard deviation* Missing data: BAI—4 patients from IG, 2 patients from CG; O...
PMC10313059
B. Longitudinal analysis: Comparison at baseline, 6 months follow-up and 60 months follow-up
PMC10313059
B1. Anxiety symptoms (BAI)
anxiety
The KST (p > .05) indicated equal distributions for IG (n = 34) and CG (n = 22). There was a statistically significant difference in median BAI anxiety symptoms at T
PMC10313059
Comparison of IG and CG boxplots of median BAI score at different time points (T0, T1, T
PMC10313059
B2. Depression symptoms (PHQ-9)
The KST (
PMC10313059
Comparison of IG and CG boxplots of median BAI score at different time points (T0, T1, T
PMC10313059
B3. Frequency of panic attacks (PAS)
(
PMC10313059
B4. Intensity of panic attacks (PAS)
The KST (
PMC10313059
B5. Patient Assessment of Chronic Illness Care (PACIC)
The KST (
PMC10313059
Discussion
agoraphobic, panic disorders, anxiety, panic disorder, panic, anxiety-related impairments, depression
VIRUS
More than five years after the original trial ended, we investigated potential long-term effects of a practice team-based intervention (CBT and case management) for patients with panic disorder during the Covid-19 pandemic. Group differences of the anxiety severity (OASIS) in cross sectional analysis at the 60months fo...
PMC10313059
Strength and limitations
depression, anxiety
The strength of the present analysis is its thorough assessment of anxiety and depression outcomes during a natural crisis situation. A limitation of the study is the low response rate. Although we tried several ways to contact participants, we could only include participants who were accessible and willing to particip...
PMC10313059
Conclusion
agoraphobia, Fuchs, anxiety, panic disorder, PD, depression
SALZMANN, FUCHS, SCHMIDT
A practice team-based intervention (CBT and case management) for primary care patients with panic disorder with or without agoraphobia may have had a lasting impact regarding anxiety severity despite the challenging context of the Covid-19 pandemic. CBT strategies which patients can apply on their own after termination...
PMC10313059
References
PMC10313059
Background
cancer, helplessness/hopelessness, anxiety
CANCER
These authors contributed equally to this work.While shared decision making (SDM) is advocated for ethical reasons and beneficial outcomes, SDM might also negatively affect patients with incurable cancer. The current study explored whether SDM, and an oncologist training in SDM, are associated with adverse outcomes (i....
PMC10712204
Design
SECONDARY, ADVANCED CANCER, REGRESSIONS
A secondary analysis of a randomized clinical trial investigating the effects of SDM interventions in the context of advanced cancer. The relations between observed SDM (OPTION12), specific SDM elements (4SDM), oncologist SDM training, and adverse outcomes were analyzed. We modeled adverse outcomes as a multivariate ph...
PMC10712204
Results
In total, 194 patients consulted by 31 oncologists were included. In a multivariate analysis, observed SDM and adverse outcomes were significantly related. More specifically, more observed SDM in the consultation was related to patients reporting more tension (
PMC10712204
Conclusions
It is important for oncologists to realize that for some patients, SDM may temporarily be associated with negative emotions. Further research is needed to untangle which, when, and how adverse outcomes might occur and whether and how burden may be minimized for patients.
PMC10712204
Highlights
cancer, anxiety
CANCER, ADVANCED CANCER
Observed shared decision making was related to more tension and uncertainty postconsultation in advanced cancer patientsHowever, training oncologists in SDM did not affect adverse outcomes.Further research is needed to untangle which, when, and how adverse outcomes might occur and how burden may be minimizedPatients wi...
PMC10712204
Methods
PMC10712204