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CHOICE Trial | cancer, Cancer | CANCER, SECONDARY, CANCER | This article describes a secondary analysis of data collected for the CHOICE trial (CHOosing treatment together In Cancer at the End of life; Netherlands Trial Registry NTR5489). A multicenter, randomized controlled design with 4 parallel arms was adopted to examine the independent and combined effect of an oncologist ... | PMC10712204 |
Recruitment and Sample | tumors | TUMORS | Medical oncologists and medical oncologists in training, who were recruited through existing networks, were eligible when treating patients with metastatic or inoperable tumors. Patients scheduled for an initial or evaluative consultation to discuss the start, (dis)continuation, or adjustment of palliative systemic tre... | PMC10712204 |
Data Collection | ADVANCED CANCER | Oncologists and patients with advanced cancer were randomized to receive an SDM skills training and a patient communication aid, respectively. Consultations about advanced cancer treatment decisions were audio recorded and assessed by trained and blinded observers. Also, patients filled out questionnaires at baseline (... | PMC10712204 | |
Measurements | PMC10712204 | |||
Sample characteristics | tumor | TUMOR | Patients reported their age, gender, educational level (low, elementary to low vocational education; medium, up until medium-level vocational education; high, high vocational or academic education), nationality, and preferred decision-making role by questionnaire. In the local case report forms, the patient’s tumor typ... | PMC10712204 |
Outcome variables | helplessness/hopelessness, anxiety | For the current analysis, the primary outcomes were the adverse outcomes as self-reported by patients shortly after the consultation (T2): anxiety, tension, loss of fighting spirit, helplessness/hopelessness, and decisional uncertainty. To explore whether SDM and adverse outcomes were related after a longer period of t... | PMC10712204 | |
Independent variables | SECONDARY | Observed SDM was assessed from audio-recorded consultations using the Observing Patient Involvement in Decision-Making scale (OPTION12), which aims to assess the extent to which health care professionals involve patients in the decision-making process.The effects of potentially burdensome elements of SDM were analyzed ... | PMC10712204 | |
Moderating variables | ’ | Patients’ preferred role in decision making was measured using the Control Preferences Scale (T0, a 1-item measure with 5 different treatment decision-making rolesType of consultation was categorized as 1) initial consultation (consultation to discuss the start of [a new line of] treatment) or 2) evaluative consultatio... | PMC10712204 | |
Statistical Analyses | To investigate the relation between SDM and adverse outcomes as well as the effect of the SDM training on adverse outcomes, we modeled adverse outcomes as a multivariate (i.e., multiple outcomes) phenomenon, because the individual adverse outcomes correlated ( | PMC10712204 | ||
Shared decision making | helplessness/hopelessness, anxiety | To model the relation between observed SDM and adverse outcomes, we fit a multivariate model that included all adverse outcomes at the first follow-up measurement (T2) as outcome variables (anxiety, tension, helplessness/hopelessness, loss of fighting spirit, uncertainty) and observed SDM as well as baseline scores of ... | PMC10712204 | |
Intervention condition (oncologist training) | The effect of oncologist training on adverse outcomes was multivariately modeled using a dichotomous variable representing whether the oncologist was trained or not as an independent variable. If the effect of oncologist training was significant, we controlled for baseline and background variables (see the “Sample Char... | PMC10712204 | ||
Long-term outcomes | T2 was small | For testing the relationship between observed SDM and long-term adverse outcomes (T3, 3 mo; T4, 6 mo), and the effect of oncologist training on long-term adverse outcomes, identical models were used as those used for analysis of the measurements shortly after the consultation T2, see Statistical analyses- Shared decisi... | PMC10712204 | |
Results | A total of 194 patients, consulted by 31 oncologists from 7 different hospitals, participated (Participant Characteristics at T2 (Total Sample)CT, computed tomography; NA, not applicable; PET, positron emission tomography; SDM, shared decision making.Missing: educational level Significant difference across conditions, ... | PMC10712204 | ||
SDM and Adverse Outcomes | Anxiety | INTERACTIONS | At 1 wk after the consultation, observed SDM as measured with the OPTION12 was significantly related to the adverse outcomes in multivariate analysis corrected for baseline variables (Multivariate Effects of Overall Observed SDM on Adverse Outcomes at T2 (1 wk) and T3 (3 mo), When Corrected for Baseline VariablesSDM, s... | PMC10712204 |
SDM Elements and Adverse Outcomes | INTERACTIONS | At 1 wk postconsultation, the observed SDM elements “setting the SDM agenda” and “exploring patient values and preferences” were not significantly related to the adverse outcomes in the multivariate analysis corrected for baseline variables (agenda setting: Univariate Models and Effects of Observed SDM in the Elements ... | PMC10712204 | |
Oncologist Training and Adverse Outcomes | At 1 wk postconsultation, oncologist training did not have a significant multivariate effect on the adverse outcomes ( | PMC10712204 | ||
Discussion | a reduced fighting spirit, cancer, helplessness/hopelessness, anxiety | CANCER, ADVANCED CANCER | In the current study, we explored the relation between SDM and potential adverse patient outcomes (i.e., anxiety, tension, loss of fighting spirit, helplessness/hopelessness, and uncertainty). We found that SDM and multivariate short-term adverse outcomes were significantly related. More specifically, more SDM in the c... | PMC10712204 |
Limitations | cancer | CANCER, ADVANCED CANCER | First, our finding that decisional uncertainty might be an adverse outcome of SDM should be interpreted with some caution, as in the current study we could not take into account the level of uncertainty that patients experienced at baseline. It might also be the case that uncertain or doubting patients would induce SDM... | PMC10712204 |
Conclusion | ADVANCED CANCER | The current study shows a relationship between SDM and adverse outcomes in patients with advanced cancer; specifically, an increase in tension and uncertainty was observed to coincide with more SDM. It is important for oncologists to realize that short-term negative emotions might occur for patients when engaging in SD... | PMC10712204 | |
Supplemental Material | PMC10712204 | |||
References | PMC10712204 | |||
1. Introduction | OA, Arthritis, cushioned shoes, knee osteoarthritis, pain, disability | ARTHRITIS, KNEE OSTEOARTHRITIS, KNEE OSTEOARTHRITIS | One of the recommendations for individuals with knee osteoarthritis (OA) is the use of specific footwear, such as sturdy or cushioned shoes. However, the long-term use effects of using cushioned shoes on the pain and spatiotemporal gait parameters in individuals with knee OA are yet to be reported. We therefore aimed t... | PMC9920540 |
2. Materials and Methods | PMC9920540 | |||
2.1. Population | RECRUITMENT | Thirty-eight individuals fitted the inclusion criteria and signed and informed consent form. The subjects were recruited using a convenient sampling method from a list of patients who were not referred to surgery or declined surgery. The recruitment process and reasons for dropping out are detailed in | PMC9920540 | |
2.2. Tools | LEUK, OA [ | PAD | The study tools were as follows: The Kellgren and Lawrence system [Spatiotemporal gait parameters were collected using a 10 camera motion capture system (Qualisys, Sweden), which was positioned along a 10 m long path. The path was equipped with a mobile safety harness that can withstand up to 500 kg of a person’s weigh... | PMC9920540 |
2.3. Study Protocol | pain | RECRUITMENT | Before the data collection, each subject was fitted with new shoes according to their group assignment. The subjects were asked to use their assigned shoes as their main footwear for the duration of the trial. Measures from both of the groups were collected at the baseline (recruitment), one month and 3 months after re... | PMC9920540 |
2.4. Statistical Analyses | pain | Considering an alpha of 0.05, a power of 95% and an allocation ratio of 2:1, we extracted the pain levels reported in [ | PMC9920540 | |
3. Results | pain | The majority of the participants rated their shoes usage as being between all the time and most of the time. We found no main effect of the group in all of the measures (For the VAS of pain score, there were statistical differences in the research group (For the WOMAC, there were statistical differences in the research... | PMC9920540 | |
4. Discussion | cushioned shoes, OA, knee pain, pain | In this double-blinded study, we showed that cushioned sport shoes, which were designed for individuals with knee OA, reduced the amount of pain in the affected knee and increased the functionality, as measured using the WOMAC subcategories. These findings were not significant in the control group. However, velocity an... | PMC9920540 | |
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC9920540 | ||
Author Contributions | Conceptualization, I.S., S.P., N.K. and Y.O.; methodology, I.S., S.P. and N.K.; software, S.P. and M.S.; validation, Y.O. and S.B.; formal analysis, I.S., Y.O., S.B., L.K., G.R., N.K., M.S. and S.P.; investigation, I.S., Y.O., S.B., L.K., G.R., N.K., M.S. and S.P.; resources, I.S.; data curation, Y.O., S.B., L.K., G.R.... | PMC9920540 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki, and approved by the Hadassah Medical Center Helsinki committee (#0457-18-HMO). | PMC9920540 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC9920540 | ||
Data Availability Statement | Not applicable. | PMC9920540 | ||
Conflicts of Interest | The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results. | PMC9920540 | ||
References | Arthritis, pain | ARTHRITIS, RECRUITMENT | Recruitment process and drop outs during the study.The Visual Analogue Scale of pain in the (The Western Ontario and McMaster Universities Arthritis Index (WOMAC) for (The (Personal characteristics of the subjects at baseline. ROM = Range of Motion; VAS = Visual Analogue Scale; TUG = timed up and go; WOMAC = Western On... | PMC9920540 |
Background | intradialytic exercise, kidney failure | KIDNEY FAILURE | Patients with kidney failure have a high mortality rate. This study aimed to evaluate the effect of intradialytic exercise on survival in patients receiving hemodialysis (HD) | PMC10108498 |
Methods | In this randomized controlled trial conducted in a HD center in Iran, adult patients receiving chronic HD were randomized to intradialytic exercise (60 min) in the second hour of thrice weekly dialysis for 6 months (intervention) or no intradialytic exercise (control). The primary outcome was survival rate at 12 months... | PMC10108498 | ||
Results | The study included 74 participants (44 males) with an age average of 64 ± 12 years old and a dialysis history of 27 ± 12 months, randomized to intervention ( | PMC10108498 | ||
Conclusion | Intradialytic | Intradialytic exercise performed for at least 60 min during thrice weekly dialysis sessions improves survival in adult patients receiving HD. | PMC10108498 | |
Trial registration | Intradialytic | ClinicalTrials.gov Identifier: NCT04898608. Retrospectively registered on 24/05/2021. Registered trial name: The Effect of Intradialytic Exercise on Dialysis Patients Survival. | PMC10108498 | |
Supplementary Information | The online version contains supplementary material available at 10.1186/s12882-023-03158-6. | PMC10108498 | ||
Keywords | PMC10108498 | |||
Background | post-dialysis fatigue, HD, sarcopenia, PD, kidney failure, intradialytic exercise | WASTING, CARDIOVASCULAR DISEASE, SARCOPENIA, KIDNEY REPLACEMENT, SECONDARY, KIDNEY FAILURE, CHRONIC KIDNEY DISEASE (CKD) | Chronic kidney disease (CKD) is a growing, global public health problem leading to an exponential increase in the number of patients experiencing kidney failure requiring treatment with life-saving kidney replacement therapy (KRT), including hemodialysis (HD), peritoneal dialysis (PD) or kidney transplantation [A signi... | PMC10108498 |
Methods | PMC10108498 | |||
Trial design | RECRUITMENT | This study is an open-label, parallel arm, randomized controlled trial with blinded end-points, which was conducted in a medical center in Iran. Recruitment occurred between January 25, 2020 and 2 February 2020. Follow-up continued until August 5, 2021. | PMC10108498 | |
Participants | cardiac instability, myocardial infarction, angina, decompensated congestive heart failure, arteriovenous stenosis, musculoskeletal pain, hyperglycemia, infection, arrhythmias, lower extremity amputation, shortness of breath | MYOCARDIAL INFARCTION, HEMODYNAMIC INSTABILITY, HYPERGLYCEMIA, INFECTION, HYPOGLYCEMIA, ARRHYTHMIAS | Individuals were eligible to participate in the study after meeting all of the following inclusion criteria: 1) age ≥ 18 years; 2) receiving regular HD 3 times a week; 3) on HD for at least 1 year, 4) absence of a history of myocardial infarction within the past 3 months; 5) permission from their physician to participa... | PMC10108498 |
Trial procedures | comorbidity, cardiac diseases, cancer, diabetes, dysrhythmia, intradialytic, cerebrovascular accident/transient | CARDIAC DISEASES, ATHEROSCLEROTIC HEART DISEASE, CANCER, GASTROINTESTINAL BLEEDING, LIVER DISEASE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, ISCHEMIC ATTACK, DYSRHYTHMIA, CONGESTIVE HEART FAILURE, KIDNEY FAILURE, PERIPHERAL VASCULAR DISEASE, DIABETES | Before starting the study, some educational and motivational posters were installed in the dialysis center, so that all patients became familiar with the benefits of exercise and especially intradialytic exercise. Then principal investigator described the side-effects of inactivity and sedentary lifestyle to all patien... | PMC10108498 |
Intervention | shoulder abduction, shoulder horizontal abduction, AV fistula, fistula, adduction | Subjects in the intervention group performed concurrent intradialytic exercise during the 2nd hour of dialysis (60-min exercise sessions three times a week) for 6 months. The intervention was a combination of aerobic and resistance exercises. Workout time at the beginning was 30 min and gradually increased to 60 min. E... | PMC10108498 | |
Blood sampling | Baseline blood samples were collected one day before the start of the exercise session. Exercise began at the mid-week dialysis session. After the end of the 36th session (end of the third month) and after the end of the 72nd session (end of the sixth month), subsequent blood samples were collected the day before the m... | PMC10108498 | ||
Outcomes | death | ADVERSE EVENTS, THORACIC | The primary outcome measure was 1-year survival. Time frame started by ending the intervention (6th month). Information about the time and cause of death were extracted from participants’ medical records. This included information recorded in the CMS-2746 form.Secondary outcome measures included changes in serum albumi... | PMC10108498 |
Adherence | Intervention adherence was defined as the number of sessions performed divided by the number of sessions offered, multiplied by 100. | PMC10108498 | ||
Blinding | BLIND | Due to the nature of the intervention, it was not feasible to blind participants or study staff.However, outcome assessors and data analysts were blinded to participants’ treatment allocations. | PMC10108498 | |
Sample size | The sample size was calculated by NCSS PASS 16.0 software. The model was established according to the log-rank test of survival analysis (bilateral side), with α = 0.05 and power 1 – β = 0.8. Due to the fact that there had been no prior randomized controlled trials evaluating the effect of exercise on survival in dialy... | PMC10108498 | ||
Statistical analysis | death | REGRESSION | Data are presented as frequency (percentage), mean ± standard deviation, or median and interquartile range, depending on data type and distribution. A detailed statistical analysis plan was prepared and completed prior to database lock. The primary outcome of survival was analyzed by Kaplan–Meier analysis and log rank ... | PMC10108498 |
Results | death | Overall, 95 patients were assessed for eligibility, of whom 74 were consented and randomized. The corresponding flowchart is presented in Fig. Participant flow during the studyDuring the 6-month intervention period, 2 participants in the intervention group and 4 participants in the control group were excluded from the ... | PMC10108498 | |
Baseline characteristics | ±, Comorbidity | Baseline characteristics were balanced between the assigned treatment groups (Table Baseline characteristics of patientsValues are as mean ± (standard deviation) or n (%)CCI Charlson Comorbidity IndexThe adherence rate was 81% ± 6%. | PMC10108498 | |
Safety | bleeding, fistula, muscle cramp | ADVERSE EFFECTS, BLEEDING | No treatment-related serious adverse effects were observed during the period of the study. During the intervention period only one of the patients had muscle cramp after two sessions of the exercise and one of the patients had bleeding from fistula when she was doing the exercises. Of course, it was not serious or harm... | PMC10108498 |
Discussion | intradialytic exercise, intradialytic, HD | This study showed that intradialytic exercise for 6 months improved subsequent survival in adult patients receiving HD for 12 months. Furthermore, compared with controls, intradialytic exercise caused potentially beneficial improvements in selected laboratory parameters (serum albumin, hemoglobin, red blood cell count,... | PMC10108498 | |
Conclusion | Intradialytic | Intradialytic exercise performed for at least 60 min during thrice weekly dialysis sessions improves survival in adult patients receiving HD. Further large-scale studies are warranted. | PMC10108498 | |
Acknowledgements | Tomas | RENAL | The authors would like to express their heart-felt gratitude to all the investigators for their contribution to the trial, especially Dr. Paul Bennett, Dr. Ken Wilund and Dr. Tomas Storer, also Dr. David W Johnson for critically reviewing and editing the manuscript, the statistical support and all the staff of the dial... | PMC10108498 |
Authors’ contributions | MAT: conceptualizing the study, project leader of the study, conducting the study, writing of the manuscript, supervising of the analysis, interpreting the results, approval of the manuscript, BC: conceptualizing of the study, supervision of the study, co-writing of the manuscript, supervising of the manuscript, approv... | PMC10108498 | ||
Funding | Not applicable. | PMC10108498 | ||
Availability of data and materials | The data used and/or analyzed during the current study (without any identifying information) are available in Figshare at | PMC10108498 | ||
Declarations | PMC10108498 | |||
Ethics approval and consent to participate | The study protocol and informed consent were approved by Iran National Committee for Ethics in Biomedical Research (approval number IR.IAU.KHUISF.REC.1399.146) and was conducted in accordance with principles of the Declaration of Helsinki. All patients provided written informed consent prior to enrollment. | PMC10108498 | ||
Consent for publication | Not applicable. | PMC10108498 | ||
Competing interests | The authors declare that they have no competing interest. | PMC10108498 | ||
References | PMC10108498 | |||
Introduction | in learning [, MP | Failure to learn is common in public schools in developing countries plagued by low quality education despite the progress made in improving access to school [The problem of poor quality outcomes is a more general one, not limited to education or to India alone, and is linked to poor delivery of services [Intended to i... | PMC10016677 | |
Methods | PMC10016677 | |||
Setting | MP | The study is a cluster randomized control trial (RCT) of 610 The trial was conducted from 2006 to 2009. Four districts were chosen purposefully in each state, matched across states by literacy rates so that they are comparable on at least one indicator of development. Within a district, 50 GPs were selected from two ra... | PMC10016677 | |
Timeline and steps of the study | PMC10016677 | |||
Timeline | MP | MAY | In MP and UP, baseline surveys were administered between February-April 2006. The first round of intervention was carried out from September 2006 to January 2007, and the first follow-up surveys administered between February and April 2007. A year after the baseline survey, focus group discussions were held in select i... | PMC10016677 |
Baseline survey | MP | In each GP, one school was randomly selected from all public schools that had grades 1 to 5. All grades 1–5 teachers were in the sample. In MP and UP, 15 students were randomly selected from each of the grades 2, 3 and 4, totaling 45 per school. In Karnataka, 30 students were selected per school, 15 each from grades 4 ... | PMC10016677 | |
Intervention | BLIND | The intervention was an information campaign. The tools used in the campaign consisted of a short film of 6 minutes, poster, wall-painting, take-home calendar and learning assessment booklet. The tools were same across states, except the information contained was state-specific. There are state-specific differences in ... | PMC10016677 | |
Focus group discussions (FGDs) and qualitative interviews | MP | One year after the first round of intervention, we conducted FGDs in 10 randomly selected intervention GPs each in MP and UP. Two focus group meetings were held in every GP, one among residents from disadvantaged social classes or low caste (Alongside FGDs, individual school committee members, 32 in UP and 50 in MP, we... | PMC10016677 | |
Analysis | REGRESSION | This paper reports impacts based on the final follow-up survey. The unit of analysis for teacher attendance and activity outcomes is the individual teacher. The unit of analysis for learning outcomes is the grade. For outcomes from interviews of school committee members, the unit of analysis is the school as explained ... | PMC10016677 | |
Ethics statement | The World Bank does not have an ethics committee to review research proposals, nor does it use an internal review board [ | PMC10016677 | ||
Inclusivity in global research | Additional information regarding the ethical, cultural, and scientific considerations specific to inclusivity in global research is included in the Supporting Information ( | PMC10016677 | ||
Results | PMC10016677 | |||
Baseline characteristics | Treatment and control villages are similar in socio-economic, demographic and other characteristics of the sample ( | PMC10016677 | ||
Impact of the information campaign | MP | REGRESSION | The analysis is based on a “difference-in-differences” linear regression where the change in outcome from baseline to follow-up is the dependent variable. For individual Because the baseline outcomes are at different levels in Karnataka compared to MP and UP, the expected impacts are likely to be different. So results ... | PMC10016677 |
Findings on impact in UP and MP | PMC10016677 | |||
Teacher effort | In UP, the intervention is associated with 12% (8 percentage points; of 68 percent at baseline) increase in teacher attendance between baseline and follow-up ( | PMC10016677 | ||
Difference-in-differences linear regression results in MP and UP where change in outcome (teacher effort) from baseline to follow-up is dependent variable. | Value represents coefficient on treatment variable. 95% confidence interval in parentheses.***P < 0.01,**P < 0.05,*P < 0.10 based on clustered standard errors.Disaggregating the analysis by characteristics of civil-service or permanent teachers, the impact is significant and greater in magnitude for high caste, male, a... | PMC10016677 | ||
Learning | REGRESSIONS | As explained in Methods section, the unit of analysis for learning outcomes is the grade because at follow-up the sample of grades 3 and 4 students is a fresh sample while grade 5 sample had participated in baseline. Therefore in learning outcome regressions we include an interaction term of a dummy variable representi... | PMC10016677 | |
School councils’ participation and awareness | MP | The difference in differences analysis was done using mean response at the GP level. Analysis was not possible at the individual member level in MP as school council elections were held anew during the course of intervention due to change in election rules that reduced the council term to one year. In UP 60% of origina... | PMC10016677 | |
Difference-in-differences linear regression results in MP and UP where change in school council outcome from baseline to follow-up is dependent variable. | MP | Value represents coefficient on treatment variable. 95% confidence interval in parentheses.***P < 0.01,**P < 0.05,*P < 0.10 based on clustered standard errors.In both states, there is an increase in members’ awareness of school accounts and of oversight roles vis-à-vis teachers, although the increase is more in UP comp... | PMC10016677 | |
Findings on impact in Karnataka | PMC10016677 | |||
Teacher effort | In Karnataka, the intervention is associated with no change in teacher attendance or activity between baseline and follow-up ( | PMC10016677 | ||
Difference-in-differences linear regression results in Karnataka where change in outcome from baseline to follow-up is dependent variable. | Value represents coefficient on treatment variable. 95% confidence interval is in parentheses.***P < 0.01,**P < 0.05,*P < 0.10 based on clustered standard errors.The impacts for Karnataka are for the two treatments pooled together. When an additional treatment dummy variable is introduced to represent the differential ... | PMC10016677 | ||
Learning | We find a consistent impact mainly in the share of children acquiring mathematics competencies ( | PMC10016677 | ||
School councils’ participation and awareness | There is no overall change in school council members’ participation associated with the intervention and in fact a decrease in the reported attendance in meetings ( | PMC10016677 | ||
Qualitative findings on the process of change | PMC10016677 | |||
Focus group discussions | MP | Findings from MP and UP are aggregated in At least 33% reported they had taken up issues of teacher presence and learning with those responsible for service delivery in schools (More than 60% of focus group participants reported using the learning assessment booklet to assess learning levels and after assessing, about ... | PMC10016677 | |
Interviews of school council members | SAID | Council members discussed the information widely, 87% had discussed the information with others and 72% said the discussion went on for weeks (Members perceived an improvement in committee meetings, which were now more inclusive and frequent after the campaign. When asked if the campaign made a difference to council me... | PMC10016677 | |
Discussion and conclusion | MP, Changing behavior | We find that providing information in a structured and repeated manner to communities enhanced the delivery of teacher effort in public school classrooms and improved learning. Improvements occurred in teacher effort, learning and functioning of school committees. The impacts were larger in UP and MP and much smaller i... | PMC10016677 | |
Supporting information | PMC10016677 | |||
Background on decentralization in basic education in the study states. | (DOCX)Click here for additional data file. | PMC10016677 |
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