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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 help sheet on acceptability ratings over time | 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 intervention based on participant feedback increases acceptability. To our knowledge, this is the first study to apply the TFA to develop an experimental approach to assess whether incorporating participant feedback brings about improvements in intervention acceptability.Although the number of participants exceeded the required numbers based on prior power calculations, there were no statistically significant differences in acceptability ratings between the control group (the original intervention) and the intervention group (a modified version of the volitional help sheet based on participant feedback) at six-month follow-up. Consequently, more changes may be required to the modified intervention to further increase acceptability. Future research should therefore aim to build on our findings and examine how making further adaptations may affect perceptions of acceptability, with a focus on two specific domains: | 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 to target specific TFA domains in future iterations of interventions (e.g. addressing perceived effort to engage with interventions). Another strength of our process is the involvement of stakeholders in the design and modification of interventions, allowing participants to provide specific feedback on an existing intervention with the overarching aim of increasing intervention acceptability and feasibility [ | 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 evaluating whether refining an intervention based on participant feedback increases acceptability. With further testing across different populations and interventions we hope the tool provides researchers with a method of improving intervention acceptability. | 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 those of the NIHR or the Department of Health and Social Care. | 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 on the affected side; also, the possibility of falling could be increased [Bisphosphonates were used as first-line therapy. However, alendronate and denosumab were found to be effective in managing patients with corticosteroids induced osteoporosis, on the other side denosumab approved in enhancing bone mineral density of the axial spine and hips and reducing incidence of fractures in women with postmenopausal osteoporosis [Changing one’s diet, taking vitamin D supplements, calcium, and bisphosphonates, which prevent osteoclastic bone resorption, considered as part of traditional therapy [High-intensity laser therapy (HILT) and extracorporeal shock wave therapy (ESWT) are promising modalities which affect bone mass as an alternative therapy. HILT is a relatively new technology. The high-power pulsed Nd: YAG laser has a high peak power and can target deep tissues, contrary to traditional lasers [Along with thermal processes, HILT causes chemical, mechanical, and other changes [A quick, brief-duration acoustic wave called an extracorporeal shock wave can carry energy and penetrate tissue. This would be a mechanical stimulation that biologically impacts living tissue [A prolonged period is consumed for any intervention used for the treatment of osteoporosis. Therefore, different modalities will be enrolled for rapid relief of osteoporotic patients’ issues such as pain, balance, and poor quality of life. Some researches approved the efficiency of HILT and ESWT on decreasing pain in musculoskeletal systems and improving dynamic and static balance which in turn could decrease falling in elderly and hemiparetic patients. The scarcity of studies concentrating on osteoporosis among hemiparetic patients makes it challenging to develop effective intervention programs that meet their specific issues. To the best of our knowledge, no study has compared the effects of HILT and ESWT in the treatment of osteoporosis consequences such as pain, balance and falling in hemiparetic patients. This study aimed to determine the outcomes of HILT and ESWT in treating osteoporosis consequences in individuals with hemiparesis. | 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 at ClinicalTrial.gov ID (NCT05616611). | 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 − 1.5 or less. All patients were recruited from Kasr Al-Ainy Hospital, Cairo University. The patients were informed about the aim of the study. All the patients signed a consent form for the participation agreement. | 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 biasFlowchart of the participantsThe patients were sorted into three groups randomly through the GraphPad QuickCalcs website (GraphPad Software Inc.) ( | 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 (SFBBS), commonly used to evaluate dynamic balance in clinical research by assessing a patient’s ability to perform seven transitional movement items [Quality of life assessment: It was performed using the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41). This is the most frequently used for patients with osteoporosis. QUALEFFO-41 covers not only patients’ aspects of pain or physical functions but also aspects of social and cognitive functions [ | 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 data were analyzed by chi-square test. P value of ≤ 0.05 was considered statistically significant. | 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 Form of Berg Balance Scale (SFBBS).A valid and reliable quality of life questionnaire to measure health-related quality of life was carried out by the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41).The primary conclusion is that combining HILT and ESWT with traditional physical therapy is more effective in increasing the overall stability index, (SFBBS), quality of life questionnaire, and lowering the VAS scores following a 12-week physical therapy alone. The results showed that although both HILT and ESWT were effective in improving the overall stability index (SFBBS) (QUALEFFO-41) and lowering the VAS ratings after receiving therapy for 12 weeks than traditional physical therapy alone in osteoporotic long-term hemiparetic patients, HILT was more effective than ESWT except for VAS.Improving the overall stability index, (SFBBS), quality of life questionnaire, and VAS scores after treatment with the modalities used in this study was reflected on the stroke patients, their ADL scores, and activity as observed in their quality of life questionnaire.The best course of treatment for osteoporotic long-term hemiparetic patients was high-intensity laser therapy (HILT) in conjunction with conventional physical therapy. Patients with the osteoporotic bone are currently treated with low-intensity laser therapy. It is a valuable physical treatment technique for enhancing range of motion [Shortly, HILT and ultrasonic wave therapy for patients with low back discomfort were compared by Fiore et al. Participants in the study underwent HILT for three weeks in a row. They demonstrated a substantial reduction in pain that was greater than ultrasound therapy [Since human skin lacks enough endogenous chromophores to absorb laser wavelength (1064 nm) effectively, the pulsed Nd: YAG laser operates in a therapeutic model that enables it to be absorbed and propagated by tissue more rapidly [Thermal build-up happens when the Nd: YAG laser is utilized continuously. HILT employed a specific waveform. 3 kW of power was reached, with frequent peaks of high amplitude for a minimal period and ultra-short duty cycle to quickly initiate photochemical and photothermal effects while reducing the thermal build-up in deep tissues [By varying the pulse frequency and strength, the photothermal effect might be managed for patient comfort and safety [The sedation impact of HILT depends on various modes of action, such as its ability to decrease the velocity of pain stimuli and boost the body’s creation of morphine-like compounds [In a study involving rabbits, it was found that the application of ESWT enhanced neovascularization and the expression of osteogenic and angiogenic growth factors at the bone junction of the Achilles tendon, including proliferating cell nuclear antigen (PCNA), endothelial nitric oxide synthase (eNOS), bone morphogenic protein-2 (BMP-2), and vessel endothelial growth factor (VEGF2 [This was further corroborated by the fact that PCNA was still elevated 12 weeks after treatment, although eNOS, VEGF, and BMP-2 effects had mostly reverted to their pre-treated levels. The biological reactions have been demonstrated in the literature for the first time. Several investigations, including non-union fractures, showed comparable findings [ESWT was used to treat individuals who had femoral head osteonecrosis. In particular research, the biological basis for ESWT’s use in treating osteonecrosis of the hip joint was investigated [In a different research, six individuals with osteonecrosis had their bone marrow stromal cells (BMSCs) removed from the femur [Extraneous factors may be corroborated to current study limitation which may have interfered with our results, such as variations in life style between patients as activity level, and psychological factor of the participants during the period of application of the study. Regarding to osteoporosis duration, it was difficult to be declared from the patients due to economic and social reasons. Analysis of gender differences on different responses of High-Intensity Laser Therapy and Shockwave Therapy on osteoporotic long-term hemiparetic patients could be a recommended future research. | 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 of the European Foundation for Osteoporosis (QUALEFFO-41) were used to assess clinical improvement in the current study. Fall risk was also assessed by the overall stability index and the Quality of Life Questionnaire of the European Foundation for Osteoporosis. These results may require further investigation using measures of bone mineral density (DEXA). | 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 examination and treatment processes before signing an informed permission form. “In addition to reading the study myself, I’ve also had it read and explained to me. When I’ve had the possibility to inquire about it, I’ve always gotten good responses. I voluntarily agree to participate in this study.” | 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 stem cell transplantation (allo-HSCT) who participated in a randomized nutrition intervention trial. Cox proportional hazards models were used to investigate possible associations between PROs collected pre-allo-HSCT (baseline) using scores from the EORTC Quality of Life Questionnaire-Core 30 (QLQ-C30) and 1-year overall survival (OS), whereas logistic regression was used to study associations between these PROs and 1-year non-relapse mortality (NRM). Multivariable analyses indicated that only the Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI) and the European Bone Marrow Transplantation (EBMT) risk score were associated with 1-year OS. In the multivariable model including clinical-sociodemographic factors for 1-year NRM, our analysis showed that living alone (The online version contains supplementary material available at 10.1007/s00277-023-05149-x. | 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 side effects that informs individually adapted clinical care, patients are scored according to standard clinical prognostic scoring systems prior to allo-HSCT, such as the Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI) and the European Bone Marrow Transplantation (EBMT) risk score. However, these scoring systems do not include patient-reported outcomes (PROs), which not only provide important information for clinical care, but may also predict survival [However, less evidence is available on the potential prognostic value of PRO data in patients undergoing allo-HSCT. Hamilton et al. showed that pre-transplant QoL and physical well-being were associated with reduced risk of overall mortality after allo-HSCT [If, as studies above indicate, PROs are documented to have a prognostic value, it can be relevant to include PROs more systematically in clinical care and follow-up. This could in turn help guide interventions to reduce mortality and morbidity, as well as improving QoL after allo-HSCT.Because of the scarcity of information on the prognostic value of PROs in this group of patients, we conducted a secondary analysis of data from an open randomized controlled trial (RCT) examining a nutrition intervention in patients undergoing allo-HSCT following myeloablative conditioning [ | 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 consent. The original RCT is registered in | 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, duration of hospitalization, days alive, and duration of out of the hospital within the first year after allo-HSCT. | 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 17 comorbidities, and as such, does not denote the patient perspective [The patients were assessed at baseline, at 3 and 6 weeks and then at 3, 6, 9, and 12 months after transplantation. In these exploratory analyses, we use clinical data and PROs at baseline. | 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 models to investigate possible associations of the corresponding pre-treatment score with the risk of dying (for any cause) over 1 year, and logistic regression for 1-year NRM, respectively. For each clinical outcome, we first ran a univariable model using sociodemographic and clinical variables. Then, we ran a multivariable model, including the statistically significant variables in univariable analysis, i.e., age, living arrangements (living alone vs. not), stem cell source (peripheral blood vs. bone marrow), and EBMT score. In addition, we forced key variables that we deemed important from a clinical point of view into the multivariable model, i.e., gender, study group (intervention vs. control), HCT-CI score, body mass index and donor type (related vs. unrelated). Then, for each outcome, we ran the same multivariable model also including the pre-treatment score of each QLQ-C30 scale. The additional information provided by a scale was evaluated by the likelihood ratio test, testing the null hypothesis that the scale did not significantly increase the model fit when added to sociodemographic and clinical variables. Values are reported as hazard ratio (HR) or odds ratio (OR). The significance level was set at 0.05 with no adjustment for multiple testing, and all statistical tests were two-sided. All analyses were performed by SAS software v.4 (SAS Institute Inc., Cary, NC, USA). | 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 excluded from further analysis (Fig. Flow chart showing the inclusion process of patients receiving allogeneic hematopoietic stem cell transplantation participating in the study, and the number of patient-reported outcomes that was analyzed | 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 stem cell source could predict 1-year NRM, and appetite loss could be the only PRO with an independent prognostic value.The HCT-CI and the EBMT risk scores as predictors of outcomes in allo-HSCT recipients have been examined in both prospective and retrospective multi-center studies [Interestingly, our analysis suggest that both stem cell source and living alone could predict 1-year NRM, but not 1-year OS, in the multivariable analyses. This finding can be explained by the causes of treatment-related morbidity and mortality, which is the main complication of allo-HSCT. For example, it is commonly reported that patients who receive stem cells from peripheral blood compared to stem cells from the bone marrow have an increased risk of GVHD [With regard to living alone as a suggested predictor for 1-year NRM, it can be assumed that for transplanted patients with one or more complications, survival may depend on whether the patients have a care person [Somewhat surprisingly, our analysis suggested that appetite loss could be associated with 1-year NRM, so that a higher appetite loss would indicate a lower 1-year NRM. Most previous research has reached the opposite conclusion [In contrast to previous studies, we did not find any significant predictors of either 1-year OS or 1-year NRM among the tested PROs derived from the QLQ C30 questionnaire (except for appetite loss as discussed above). This is in contrast with Hamilton and collaborators’ extensive study on PROs being predictive for survival, relapse, and NRM after allo-HSCT, where they found that physical well-being was prognostic for overall mortality [Our study had some limitations. The exploratory nature of our analysis should be considered when interpreting the results, and the sample size was not large enough to conduct specific sub-analyses. Also, we studied a rather homogeneous patient population that may limit the generalizability of our findings. A strength of our study is the high-quality data obtained in the context of a robust RCT setting in a well-defined patient group.In conclusion, whereas our analysis suggest that the two common risk tools (HCT-CI and EBMT risk scores) were predictive for 1-year OS and 1-year NRM, baseline PROs data had little or no associations with these outcomes in this specific setting. | 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 full access to all the data in the study and had final responsibility for the decision to submit for publication. | 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 Pharmaceuticals, and Mundipharma. Other authors declare no conflicts of interest. | 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 endurance with dread of situations from which escape might be difficult or help unavailable in the event of a panic attack. Typical agoraphobic situations include shopping malls, theatres, traveling by bus, crowded restaurants, and being alone [Cognitive behavioural therapy (CBT) shows strong effectiveness for a variety of mental illnesses, including anxiety-related disorders [The PARADIES (“Patient Activation foR Anxiety DIsordErS”) trial, a two-armed cluster randomized controlled trial (cRCT), was conducted between 2012 and 2016 in the German federal states of Bavaria, Hesse, and Thuringia in rural or urban general practitioners (GPs) practices [There are few studies only that follow up the effectiveness of CBT for patients with anxiety disorders over a longer period of time (> 2 years) [The aim of the present study was to investigate whether the positive effects of a practice team-based intervention ("PARADIES") with elements of CBT for primary care patients with panic disorder with or without agoraphobia (ICD-10: F41.0 or F40.01) still hold up five years after its end in the context of a natural crisis such as the Covid-19 pandemic. For this reason, we assessed anxiety and depression related clinical parameters in a sample of the original study population in order to measure potential long-term success. | 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 agoraphobia (mean age: 46.2 years [standard deviation: 14.4]; 74% female). At baseline, patients were blinded to group membership. Patients in the intervention group (IG, 36 practices, 230 patients) received case-management [Initially, patients were screened by participating GPs and their teams, using the Overall Anxiety Severity and Impairment Scale (OASIS) [The PARADIES study was approved by Ethics Committee of the Friedrich-Schiller University Jena on 17 August 2012 (no. 3484–06/12). All participating physicians and patients gave their written informed consent to participating in the study. The study was registered with Current Controlled Trials (ISRCTN64669297) and the German Clinical Trials Register (Deutsches Register Klinischer Studien, DRKS, DRKS00004386). | 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%) patients from 25/37 practices in the CG. In sum, a total of 100 patients from 52 practices could be included in the present study. For a detailed description of participants and drop-outs, see flow chart ( | 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; OASIS—1 patient from IG, 2 patients from CG; MIA—3 patients from IG, 1 patient from CG; PHQ-9–5 patients from IG, 2 patients CG; fear-of-COVID-19-scale: from 5 patients from IG, 5 patients from CG; PAS_A1–3 patients from IG, 2 patients from CG; PAS—3 patients from IG, 2 patients from CG.The results of the scores measuring depression (PHQ-9), satisfaction with outpatient treatment (PACIC), frequency and severity of panic attacks (PAS_A1 and PAS_A2), the Mobility Inventory (MIA) and mean Covid-19 anxiety (fear-of-COVID-19-scale) were also better in the IG than in the CG (see | 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 follow-up were found with medium effect sizes. Especially one item differed between groups with large effect size (“How much does anxiety or fear affect your ability to complete necessary tasks at work, school, or home?”), indicating that the intervention group suffered less from impairment through fear. However, these are very tentative interpretations, since after Bonferroni correction significance level was no longer reached.In general, while CBT is widely recognised as effective treatment for panic disorders [Interestingly, in our study, the IG and CG differed moderately to strongly with regard to anxiety severity and impairment (measured by OASIS) but not with regard to the other anxiety scales (measured by BAI, PAS, Fear-of-Covid-19-Scale, and MIA). This might be related to what the different anxiety scales address in detail: The BAI asks about various physiological anxiety symptoms, the two PAS items address frequency & intensity of panic attacks, Fear-of-Covid-19-Scale refers to fears and physical sensations in association with the virus and the MIA deals with agoraphobic avoidance behaviour. The OASIS uniquely asks specifically how fear impairs people in their everyday life: The last two OASIS items examine the extent of anxiety-related impairments in professional/domestic (Item 4) and social (Item 5) domains and the total sum score negatively correlates with the construct of perceived quality of life [We assume that CBT-based interventions including psychoeducation may have a positively affected patients’ understanding of their symptoms; thus, they might feel less impaired by their panic attacks and anxiety symptoms in everyday life, even in a crisis situation like the Covid-19 pandemic. Furthermore, the pandemic might have resulted in positive and potentially buffering changes for some, including a better work–life balance through home-office [In the longitudinal analysis, IG and CG both showed an increase in anxiety and depression symptoms, which might be attributed to the external circumstances brought about by the pandemic. The slightly better values of the IG regarding anxiety and depression could be due to the fact that these patients might have maintained behaviour and self-management strategies, which helped them cope with the crisis situation. However, we must also keep in mind that there might have been many other factors within the six years after the end of the original trial which influenced people’s behaviour and which we did not assess.Germany-wide data from surveys conducted by a large insurance company over the last 30 years showed that in the German population, anxiety levels were at an all-time low in 2020 and 2021 [Patient assessment of chronic care was significantly lower during the 60 months follow-up, probably because GP care reached its limit during the pandemic: GPs were overburdened with vaccinations and Covid-19 patients; additionally, they had to cope with staff shortages due to the Covid-19 pandemic. Thus, they might not have the appropriate time for their chronic patients. Our findings coincide with a survey that was commissioned by the AOK-Bundesverband (Federal Association of the health insurance “AOK”) and has been conducted in several waves since 2019 (N = 2000 participants). It found that since the beginning of the Covid-19 pandemic, fewer and fewer Germans believe that health care in their region works well or very well [During the Covid-19 pandemic, access to health services was difficult; thus, technological advancements, e.g. eHealth supported tools or iCBT, should be considered as promising solutions [ | 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 participate. Small numbers of subjects may result in lower statistical power. Thus, we want to emphasize that the interpretations of our results is tentative.Moreover, it is possible that only particularly motivated and psychologically less stressed–or conversely, particularly stressed–patients participated. We tried to counteract potential selection bias by repeatedly contacting reluctant participants. Compared to the original trial, participants at follow-up were older than the elapsed time would suggest. This may be why the online questionnaire was so poorly received. We tried to address this through phone calls and postal letters. In our study, anxiety severity (OASIS) showed a difference between IG and CG. However, due to the cross-sectional character of the OASIS-data, we cannot draw firm conclusions regarding the long-term effectiveness of a practice team-based CBT-intervention in primary care. The PARADIES intervention is not part of standard care in Germany and thus, only available from few GPs. | 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 of treatment (e.g. exposure therapy, behavioural activation, reduction of avoidance behaviour) seem to be a promising strategy for promoting long-term success. However, other factors may have also helped with coping, and therefore, it is unclear to what extent the intervention still played a role in participants’ lives. Additionally, the increase in anxiety and depression symptoms in both groups over time could be attributed to external circumstances, highlighting the need for further research to better understand the impact of the pandemic on mental health.The authors would like to thank all participants of the PARADIES-study who participated in this Corona follow-up; all people who helped recruiting patients; D. Fuchs and R. Gehrke for their support in preparing and analysing the data.The authors thank the PARADIES study group for which Jochen Gensichen is lead author: Dr. Wolfgang Blank, Kirchberg im Wald, Germany; Dr. Florian Bleibler, Hamburg-Eppendorf, Germany; Jörg Breitbart, Jena, Germany; Dr. Christian Brettschneider, Hamburg-Eppendorf, Germany; Anne Brokop, Jena, Germany; Prof. Dr. Jochen Gensichen, München, Germany; Thomas Hiller, Jena, Germany; Dr. Heike Hoyer, Jena, Germany; Dr. Bert Huenges, Bochum, Germany; Michelle Kaufmann, Jena, Germany; Prof. Dr. Hans-Helmut König, Hamburg-Eppendorf, Germany; Dr. Armin Mainz, Korbach, Germany; Prof. Dr. Jürgen Margraf, Bochum, Germany; Pauline Masopust, Jena, Germany; Alexander Piwtorak, Jena, Germany; Rebekka Salzmann, Jena, Germany; Prof. Dr. Sylvia Sänger, Gera, Germany; Mercedes Schelle, Jena, Germany; Prof. Dr. Peter Schlattmann, Jena, Germany; Dr. Konrad Schmidt, Jena, Germany; Nico Schneider, Jena, Germany; Dr. Elisabeth Schöne, Jena, Germany; Dr. Sven Schulz, Jena, Germany; Dr. Ulrike Schumacher, Jena, Germany; Dr. Michael Sommer, Jena, Germany; Monika Storch, Jena, Germany; PD Dr. Tobias Teismann, Bochum, Germany; Franziska Theune-Hobbs, Jena, Germany; Dr. Paul Thiel, Hildesheim, Germany; Prof. Dr. Michel Wensing, Heidelberg, Germany. | 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.e., patient anxiety, tension, helplessness/hopelessness, decisional uncertainty, and reduced fighting spirit). | 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 phenomenon, followed by univariate regressions if significant. | 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 with incurable cancer need to make complex treatment decisions, since treatment options often have no clear benefit-harm ratio: the outcomes are uncertain, the survival benefit is often limited, and the burden of treatment can be high. As a result, patients’ preferences are decisive in determining the best treatment strategy. Such preference-sensitive treatment selection requires shared decision making (SDM).Aside from its ethical imperative, SDM has been advocated because of evidence for its beneficial effects, such as on patients’ satisfaction with communication, well-being, and quality of life.While the potential burden of SDM is acknowledged in the literature, little evidence exists to explain or support this phenomenon. There is tentative evidence that some patients may experience adverse outcomes after engaging in SDM, such as anxiety, dissatisfaction with the decision, and increased decisional conflict,The current study aims to explore whether SDM is associated with adverse outcomes, based on data of a previous study, the CHOICE-trial. | PMC10712204 |
Methods | PMC10712204 |
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