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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 training and a patient communication aid on observed SDM about palliative cancer treatment in clinical consultations. | 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 treatment in 7 Dutch hospitals were invited for participation. Eligible patients were diagnosed with metastatic or inoperable tumors for which the indicated median life expectancy without disease-targeted treatment was less than 12 mo and palliative systemic treatment would not offer a median survival benefit of more than 6 mo. | 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 (T0), in the waiting room (T1), and at 1 wk (T2), 3 mo (T3), and 6 mo (T4) after the consultation. Data collection took place between February 2016 and June 2018. | 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 type and the type of consultation (first/evaluative) were registered; the results of the (positron emission tomography [PET])computed tomography (CT) scan in case of evaluative consultations, patients’ World Health Organization performance status at the time of the consultation (0–4), and the line of therapy that was discussed during the consultation were extracted from the medical record. | 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 time, measurements of adverse outcomes at 3 (T3) and 6 mo (T4) after the consultation were used. For decisional uncertainty, no long-term measurements were available. | 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 separately. SDM elements were defined using the separate stages of Stiggelbout et al.’s model of SDM (stage 1, “setting the SDM agenda”; stage 2, “informing about the options”; and stage 3, “exploring patient values and preferences”Two trained and blinded assessors independently rated the consultation using both scales (OPTION12 and 4SDM) after training and calibration. The intraclass correlation was strong (>0.80) and the average weighted kappa sufficient was >0.60 for OPTION12 (0.62) and was almost sufficient for 4SDM (0.57).The second independent variable was the intervention condition of the oncologist (i.e., whether the patient consulted a trained or untrained oncologist). The patient communication aid condition was ignored for this secondary analysis, as the observed SDM behavior of oncologists was not shown to be affected by the aid. | 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 consultation (consultation to discuss the [dis]continuation or adjustment of treatment on the basis of CT or PET-CT evaluation). | 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 all adverse outcomes as independent variables. Including baseline adverse outcomes (T0) in the model allowed us to control for baseline differences between patients. For tension, the measurement shortly before the consultation in the waiting room (T1) was considered the baseline. For uncertainty, no preconsultation baseline measurements were available.To test if the relationship between SDM and adverse outcomes was moderated by preferred role in decision making and type of conversation, we also tested for multivariate interactions. In univariate analyses of SDM and each of the separate adverse outcomes, we controlled only for the corresponding baseline adverse outcome to reduce multicollinearity.A similar modeling approach was used to investigate the relationship between the separate SDM elements and adverse outcomes. We fit a multivariate model for adverse outcomes at follow-up using the individual elements of SDM and baseline adverse outcomes, after which we also tested for interactions between stage 1 (agenda setting) and 3 (exploration) and between stage 2 (information giving) and 3 (exploration). Again, both multivariate and univariate analyses were controlled for baseline differences and moderating variables. | 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 Characteristics” section) that were significantly different between patients consulted by a trained or untrained oncologist. | 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 decision making and Statistical analyses- Intervention condition (oncologist training)). As for decisional uncertainty, no measurements at T3 nor T4 were available; this outcome variable was excluded from the models. To ensure sufficient statistical power at T3 and T4, analyses were performed only if the dropout percentage compared with T2 was small enough for imputation (<50%). | 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, Results (PET)CT were reported only in case of a evaluative type of consultation; see this characteristic for total 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, shared decision making; STAI, State and Trait Anxiety Inventory; VAS, visual analog scale.Results are shown separately for each model (with and without interactions).Significant univariate effects of overall observed SDM on specific adverse outcomes at Indicates no significant multivariate interaction effect.Univariate Models and Effects of Overall Observed SDM on the Separate Adverse Outcomes at T2 (1 wk), when Corrected for Baseline VariablesSDM, shared decision making; STAI, State and Trait Anxiety Inventory.Significant univariate effects of overall observed SDM on specific adverse outcomes at Interactions between SDM and both preferred role (At 3 mo postconsultation (T3, sample size: Multivariate Effects of Observed SDM in the Elements of “Setting the SDM Agenda,”“Informing about the Options,” and “Exploring Patient Values and Preferences” on Adverse Outcomes, at T2 (1 wk) and T3 (3 mo), when Corrected for Baseline VariablesResults are shown separately for each model (with and without interactions).Significant univariate effects of overall observed SDM on specific adverse outcomes at | 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 “Setting the SDM Agenda,”“Informing about the Options,” and “Exploring Patient Values and Preferences” on the Separate Adverse Outcomes at T2 (1 wk) when Corrected for Baseline VariablesSignificant univariate effects, without significant multivariate effects. Following our analysis plan, these were not considered significantly related.Significant univariate effects of overall observed SDM on specific adverse outcomes at Interactions between “setting the SDM agenda” and “exploring patient values and preferences” (At 3 mo postconsultation, no significant multivariate relations were found between the SDM elements and adverse outcomes (agenda setting: | 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 consultation was related to more tension and decisional uncertainty after the consultation. “Informing about the options” was the only SDM element found to be significantly related to adverse outcomes (i.e., to more helplessness/hopelessness and tension) after the consultation. These results imply SDM may be associated with negative emotions for some patients. Whether the patient consulted with an SDM-trained oncologist or not did not affect adverse outcomes. In addition, we did not find any relation with long-term adverse outcomes, suggesting that the found associations are transient.Our finding that SDM might not only be related to beneficial but also to adverse outcomes is in line with speculations and findings in the literature.It may be important to further reflect on the concept of “adverse outcomes.” In this study, we focused on outcomes related to patients’ emotional status, that is (a combination of) patients’ anxiety, tension, reduced fighting spirit, helplessness/hopelessness and decisional uncertainty. However, there may be various other outcomes playing a role in the potential burden of SDM for patients, for example, cognitive factors such as dissatisfaction with the decision and decisional conflict or relational outcomes between oncologist and patient, such as a potential decrease in patients’ trust in the oncologist, perceived empathy, or feeling of support by the oncologist. In addition, it is still unknown how potential adverse outcomes relate to and interact with each other. It might, for instance, be that decisional uncertainty would mediate the relationship between SDM and tension, which should be explored in further research. Lastly, we have included a reduced fighting spirit as one of the “adverse outcomes,” yet one could similarly argue that reduced fighting spirit, perhaps accompanied by a more accepting stance, actually reflects an adaptive response when facing incurable cancer. In line, a recent study showed that patients with low fighting spirit were more likely to have prognostic perceptions similar to that of their oncologist.Interestingly, our study showed no influence of patient role preferences on the relation between SDM and adverse outcomes; that is, whether a patient prefers an active v. a rather passive role in decision making does not influence experienced SDM burden as much as we expected. Nonetheless, it is of great importance that oncologists take into account their patients’ needs and wants when making a decision, also in regard to their preferred decisional role. Inherent to the principles of SDM, SDM should be regarded as means to an end and not be executed at any cost, as this would contradict the idea that patients’ preferences are accounted for.When considering the relations between separate elements of SDM and adverse outcomes, adequately informing patients on the available options and their pros and cons was found to be related to patients experiencing more tension and helplessness/hopefulness shortly after the consultation. It could be that the potentially challenging information on life expectancy, which is uncertain and in the case of advanced cancer often limited, plays a key role in this relationship. In fact, it might not be surprising that patients who have just learned that treatment can prolong their life with only an extra few months feel hopeless or tense. Especially since earlier research suggests that many patients with advanced cancer are not aware that chemotherapy is not intended to cure their cancer.Although we did find observed SDM to be related to adverse outcomes, we did not find a significant effect of SDM training on adverse outcomes in the short or long term. This means that we did not find either more or less adverse outcomes in the training condition compared with the control condition. Despite the fact that the training was not targeted at preventing adverse outcomes in patients, possibly trained oncologists still managed to perform SDM in a way that did not raise adverse outcomes as opposed to SDM performed by untrained oncologists. On the other hand, it might be that trained oncologists performed SDM more standardly, independent of patients’ context and circumstances, and—related—their emotional well-being. Either way, future SDM training programs should inform health care professionals that SDM might relate to negative emotions and provide them with tools on how to offer support in these situations. Further research should explore how patients experience burden and what might help them to reduce it to a minimum. | 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 behavior in oncologists. For example, if patients seem uncertain or hesitant about a treatment decision, oncologists may explain treatment options more elaborately or engage in preference construction. Second, despite the baseline controls performed for the other adverse outcomes, causality can also not be claimed for the other relationships found, due to the cross-sectional design of this study. The fact that a randomly assigned and highly effective oncologist training in SDM did not significantly relate to adverse outcomes might further substantiate that the reported relation between observed SDM and adverse outcomes is not necessarily, or purely, causal. Third, the follow-up measurement took place not directly but 1 wk after the consultation, possible influencing the outcomes. Lastly, it is important to bear in mind that our results apply only to the specific setting of patients with advanced cancer, defined as having a median life expectancy <12 mo and an expected median survival benefit of <6 mo due to treatment. Further research should determine how these results would translate into other cancer settings. | 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 SDM, for which oncologists could be equipped through future SDM training programs addressing this issue. The current oncologist SDM training did not affect adverse outcomes. Although our results do not show what the exact cause of adverse outcomes might be, they do show that the element of informing patients might specifically be associated with short-term adverse outcomes (i.e., patients might temporarily feel more tense and more helpless or hopeless when adequate information is given in order to decide on treatment). However, further research is needed to untangle exactly which, when, and how adverse outcomes of SDM might occur, how patients experience these, and how burden might be minimized. | 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 to compare the efficacy of cushioned sport footwear versus sham shoes on motor functions, pain and gait characteristics of individuals with knee OA who used the shoes for 3 months. In a double-blinded study, we provided 26 individuals with knee OA with cushioned sport shoes and 12 individuals with knee OA with similar sport shoes without cushioning for 3 months. The gait analysis, the timed up and go (TUG) test and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) were conducted and the pain levels were measured at the baseline, 1 month, and 3 months after the baseline. We found that the cushioned shoes reduce the amount of pain (based on WOMAC) in the affected knee and increase functionality in the research group, but not in the control group. Gait velocity and cadence were increased in both groups. Gait spatiotemporal parameters and their symmetry were unaffected during the intervention. We conclude that the use of cushioned shoes should be recommended to individuals with knee OA for alleviating pain.Knee osteoarthritis (OA) is a principal cause of disability in the adult population [As reviewed in [The literature shows that the efficacy of various soles and shoe designs for alleviating pain and promoting function in individuals with knee OA is controversial and depends on the design of the footwear. However, a survey of 204 individuals with knee OA reported that most of them did not receive professional advice from a podiatrist or physiotherapist regarding their footwear [ | 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 weight and can be fitted to the body characteristics of the subject in order to prevent a fall. Four passive markers were placed bilaterally on the heel and forefoot. The 3D coordinates of the markers and the stance and swing timings which were derived from using the motion capture system were transformed into a code, which was created for this study in LabView (version 2017, National Instruments, Austin, TX, USA). This code also calculates a Symmetry Index (SI) for all of the spatiotemporal parameters according to the following formula [The intervention involved the provision of new sport shoes (LEUK for women and THUN for men; Kybun AG, Roggwil, Switzerland). All of the participants were given the same brand of non-cushioned shoes and the same brand of cushioned shoes. The research group received shoes embedded with a sole that consists of a multi-component polyurethane, in which tiny air bubbles have been sealed. This “air pad” cushioning was designed to promote comfort. The control group was provided with sham shoes, i.e., identical shoes in terms of the exterior, but with regular soles. All of the subjects received bilateral shoes, as provided in most research studies of footwear intervention for individuals with OA [ | 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 recruitment. All of the measures of knee ROM, pain on the VAS, WOMAC and TUG were collected. In the gait laboratory, after the four markers were placed on the subjects, they were asked to walk at a comfortable speed 3–4 times along the 10 m long paved path. The subjects were asked to rate at the end of the study whether they wore the shoes all of the time, most of the time, a few hours a day or whether they hardly wore the shoes. | 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 group for the WOMAC pain score (The within-group differences in gait velocity and cadence are presented in In the additional analyses for all of the study population, there was no statistically significant correlation between the ratio of VAS pain score of the ipsi-lateral and contra-lateral knee at the baseline and the WOMAC of physical function score at the baseline (r = −0.233, | 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 and cadence were increased in both the research group, who used the cushioned shoes, and the control group, who used similar un-cushioned shoes. The gait spatiotemporal parameters and their symmetry were unaffected during the long-term (3 months) intervention. While cushioned shoes are sometimes recommended for individuals with knee OA, this is the first piece of evidence of their efficacy in alleviating pain and increasing functionality.Studies have shown great variability in the progressiveness of knee pain in individuals with OA. The variability is affected by different factors, e.g., knee characteristics, sex (females have worse prognoses) and clinical factors, as well as psychological factors [The presence of knee pain is a risk factor for reduced physical function. Middle-aged individuals with OA are more likely to develop difficulties in mobility and daily functioning as they become older [Although all of the members of the study population increased their gait velocity and cadence, there were no statistically significant differences in the gait pattern or gait symmetry. We expected changes in the gait pattern, in accordance with the previous results exploring the biomechanics of walking with cushioned shoes. In a previous study, the research showed that there are biomechanical differences in older females walking with maximally and minimally cushioned shoes and conventional shoes [The study limitations include a small sample size, although this might not have affected the power of our results, as shown by the large effect sizes presented in | 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., N.K. and M.S.; writing—original draft preparation, S.P.; writing—review and editing, I.S., Y.O., S.B., L.K., G.R., N.K., M.S. and S.P.; visualization, S.P.; supervision, I.S.; project administration, Y.O., S.B., L.K., G.R. and N.K.; funding acquisition, I.S. All authors have read and agreed to the published version of the manuscript. | 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 Ontario and McMaster Universities Arthritis Index.Results of the repeated measures analysis of variance (ANOVA). Data are presented as F, p and effect size (partial η | 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. Secondary outcomes were serum albumin, hemoglobin, hematocrit, red blood cell count, serum calcium, serum phosphorous, parathyroid hormone, physical function (6-min walk test) and nutritional status (Geriatric Nutritional Risk Index) during the first 6 months. The trial follow-up period was 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 significant factor underpinning these poor outcomes in HD patients is low physical activity related to high rates of comorbidities (such as cardiovascular disease), protein energy wasting, sarcopenia, decreased physical function, decreased aerobic capacity, enforced inactivity during thrice weekly HD sessions, and post-dialysis fatigue [A systematic review and meta-analysis of 20 randomized controlled trials involving 677 participants receiving HD demonstrated that exercise training increased exercise capacity (peak VOThe aim of this study was to evaluate the effects of intradialytic exercise on survival in patients receiving HD. A secondary aim of the study was to assess the effect of intradialytic exercise on clinical outcomes associated with patient survival. | 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 participate; and, 6) had capacity to provide informed consent to participate in the study. Individuals were excluded if they met any of the following exclusion criteria: 1) cardiac instability (angina, decompensated congestive heart failure, severe arteriovenous stenosis, uncontrolled arrhythmias, etc.); 2) active infection or acute medical illness; 3) hemodynamic instability (systolic blood pressure < 90 mmHg or mean arterial pressure < 60 mmHg); 4) labile glycemic control (extreme swings in blood glucose levels, causing hyperglycemia or hypoglycemia); 5) inability to exercise (e.g. lower extremity amputation with no prosthesis); 6) severe musculoskeletal pain at rest or with minimal activity; 7) inability to sit, stand or walk unassisted (walking device such as cane or walker allowed); or 8) shortness of breath at rest or with activities of daily living (NYHA Class IV). | 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 patients. Actually, he encouraged all the patients to be active and gave them awareness about the intradialytic exercise and how it can help them.After providing written informed consent, eligible patients received a baseline assessment. Data were collected on demographic characteristics (age, sex and time on hemodialysis), primary cause of kidney failure, and comorbidities (atherosclerotic heart disease, congestive heart failure, cerebrovascular accident/transient ischemic attack, peripheral vascular disease, dysrhythmia, and other cardiac diseases, chronic obstructive pulmonary disease, gastrointestinal bleeding, liver disease, cancer, and diabetes). Comorbidities were quantified using Charlson comorbidity index (CCI) established for dialysis patients, which included the underlying cause of kidney failure, as well as 11 comorbidities [Participants were then randomized in a 1:1 ratio to either the intervention group or control group. The randomization sequence was generated by a study biostatistician who was not otherwise involved in the study using a computer-generated random schedule (using Stata 16, Stata Crop, College Station, Tx). Allocation concealment was safeguarded through the use of sequentially numbered, sealed, opaque envelopes by a specified staff member who was not involved in the study. | 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. Each workout session included 5 min of warm-up, aerobic exercises, resistance exercises and finally 10 min of stretching exercises to cool down. The fistula arm was kept stationary thoroughly the exercise session, with necessary precautions taken into consideration. Also, the exercise protocol was not performed on the arm with AV fistula.Exercises were individualized in a way that matched the level of physical fitness of participants (See Aditional File 1). Aerobic exercises consisted of continuously performed specified movements, such as moving legs back and forth, shoulder abduction and adduction (hand without fistula), flexing and extending the knee, internally and externally rotating the leg, and abducting and adducting the leg, in time with a played beatThe rhythm of continuous movements was adjusted by the beats per minute of the music. This meant that participants had to coordinate the movements of their arms and legs with the beats per minute of the song being played to them. In this way, the speed and intensity of aerobic exercise was controlled by the rhythm. Resistance training was performed in a semi-recumbent position and included exercises for the upper and lower limbs as well as core strength exercises using body weight, weight cuffs, dumbbells, and elastic bands of varying intensity. Chest press, shoulder press, triceps extension, straight arm shoulder flexion, shoulder horizontal abduction,seated row, supine grip, prone grip, neutral grip, bicep curl, leg abduction, plantarflexion, dorsiflexion, straight-leg/bent knee raises, knee extension, and knee flexion were all part of the resistance training program.All of the exercises were prescribed by an exercise physiologist. He accompanied patients to monitor the performance of the exercises. If the patient had a problem in performing the exercises, he helped them and answered any questions raised. At the end of each session, the exercise physiologist reviewed the adherence checklists. If a person had not attended an exercise session, a counseling session were held with the presence of a nephrologist and the exercise physiologist. The reason for the individual's non-participation was investigated and the positive effects of exercise were explained through motivational statements. In addition, if possible, the positive effects of exercise that have had happened to them so far were explained as an incentive for them to participate more in training sessions.Participants in the control group did not undertake any specific physical activity during dialysis. All participants were followed for 12 months.All other pharmacological, dialysis, dietary and management protocols were identical for participants in both groups. (Despite of differences between some hematological parameters at baseline, different medications were not used for intervention group.) All participants received normal bicarbonate hemodialysis, which was carried out three times a week for an average of 4 h. Volumetric ultrafiltration control was available on all machines. The standard dialysate flow rate was 500 mL/min and blood flow rates were prescribed according to the participant’s needs. Automated methods were applied to perform dialyzer reuse uniformly. | 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 midweek dialysis session. The control group was assessed at the same time points. On a nondialysis day, blood samples were taken from the arterial needle after at least an 8-h fast. Approximately 30 ml of blood were collected and centrifuged for 15 min at 20 °C and 2500 g. Plasma was next pipetted into cryotubes and stored at -80 °C in a freezer that was electronically monitored. All samples were measured in duplicate, in line with the manufacturer's suggested protocol, and within the manufacturer's specified range of acceptable variation and sensitivity. | 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 albumin (g/dL), hemoglobin (g/dL), hematocrit (%), red blood cell count (× 10Physical function was evaluated with the 6-min walk test (6MWT), which is a functional examination of exercise capacity and was performed according to the American Thoracic Society guidelines [Nutritional status was assessed by Geriatric Nutritional Risk Index (GNRI), as reported by Bouillanne et al. [Safety outcomes included all serious adverse events and adverse events. | 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 dialysis patients, the results of a non-randomized study of the association of changes in physical activity with survival in dialysis patients were used to inform sample size calculations [ | 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 test. Overall survival was calculated from the date of the end of intervention to the date of death from any cause. Participants remaining alive were censored at the date of last follow-up. Cox regression model was constructed to evaluate the effect of intervention on survival rate. Secondary outcomes were evaluated using Repeated Measure ANOVA and Friedman test. Statistical analyses were performed using IBM SPSS software 25. | 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 intervention. Every patient who was lost to follow-up (for any reason except death) during 12-month follow-up was censored. | 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 harmful. | 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, serum calcium, serum PTH, serum phosphorus), physical function (6MWT) and nutritional status (GNRI) during the 6-month intervention period.The finding of a survival benefit from intradialytic exercise is in keeping that of with previous observational studies investigating the association between increased physical activity and survival in patients receiving dialysis [The mechanisms underpinning the improved survival of patients performing intradialytic exercise for 6 months may be explained by improvements in a number of factors associated with physical exercise including bone mineral metabolism [A major strength of the present study was the fact that all exercises were tailored according to each individual's functional status within a pre-specified structure. There was also a high participation rate, such that included HD patients exhibited considerable diversity with respect to demographic characteristics and associated comorbidities. The study also evaluated a range of biochemical and functional parameters. The intervention was designed so that it was broadly implementable in most HD centers, including in low resource settings.Balanced against these strengths, the study also had a number of limitations. The duration of the intradialytic exercise intervention was short (6 months), as was the subsequent follow-up (12 months), meaning that the long-term effects of exercise on patient survival remain uncertain. The small sample size led to an imprecise estimate of the effect of exercise on patient survival. Survival was timed from the end of the intervention, which introduced immortal time bias. Secondary outcome measures exploring the effects of intradialytic exercise and patient survival were only examined during the first 6 months of the study. | 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 dialysis center for their efforts and patience in helping to maintain the standards of the research, as well as all patients involved in this study. Also, the authors would like to thank Pardis Specialized Wellness Institute and all the personnel of the institute for their support throughout the study. The authors would also like to thank the opportunity that medRxiv offered them to deposit the preprint version.This study is endorsed by the Global Renal Exercise (GREX) network. The interpretation and conclusions contained herein are those of the researchers and do not represent the views of GREX. | 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, approval of the manuscript, NS: project leader of the study, analyzing the data, interpreting the results, co-writing of the manuscript, approval of the manuscript, HC: conceptualizing the study, supervising of the study, co-writing of the manuscript, supervising of the manuscript, approval of the manuscript, SA: conceptualizing the study, conducting the study, co-writing of the manuscript, approval of the manuscript. Each author contributed with important intellectual content during the manuscript drafting or revision and accepts accountability for the overall work by ensuring that questions pertaining to the accuracy or integrity of any portion of the work are appropriately investigated and resolved. All authors read and approved the final manuscript. | 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 increase service providers’ accountability to the local community, India like a number of developing countries has decentralized control over public services to local communities [One way to enhance accountability may be to provide information that empowers stakeholders to demand quality services [We conducted a community-based randomized controlled trial to determine the impact of information delivery on education outcomes. The campaign gave information to parents on their oversight roles in schools and education services they are entitled to. A key feature of the campaign was community-wide big public meetings that parents, teachers and school committee were invited to attend. Over a period of two and a half years and two rounds of intervention, 11–14 public meetings took place in each treatment village. Our hypothesis was if communities are empowered with this information, outcomes may improve.The study was conducted in three Indian states—Karnataka, Madhya Pradesh (MP) and Uttar Pradesh (UP). An amendment to the Indian Constitution in 1992, the 73The size of the impact of such an intervention will depend on several factors. First, changing attitudes and behavior require time, so time elapsed between the intervention and follow up survey is important. The extent of oversight communities have over schools and extent of public action in response to the campaign will also matter. The impact of the campaign at midline 2–4 months after one round of the intervention showed an increase in teacher effort and modest gains in learning [ | 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 randomly chosen blocks. A block is the administrative unit between a district and a GP. We used a random number generator to randomly select blocks and then GPs within the blocks. Half of the GPs within each block were then randomly assigned to intervention arm and the remaining half to control arm. Treatment and control GPs were evenly spread across the two blocks to reduce any potential contamination. This gives a total of 100 control GPs and 100 treatment GPs per state in MP and UP.In Karnataka the design was identical except an additional set of treatment villages was added that received a slightly different treatment called information and advocacy campaign. The number of GPs in each of the three cells in Karnataka, control, treatment 1 (information campaign), treatment 2 (information campaign plus advocacy), totaled 70.Sample sizes were determined using cluster randomized sample size calculations based on a 5 percent significance level and 80 percent power. | 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 intervention GPs. A second round of intervention was from September 2008 to January 2009, with second follow-up surveys between February and April 2009. In Karnataka, baseline surveys were administered between July and August 2006. The first round of intervention was from February to May 2007, and the first follow-up surveys between July and August 2007. The second round of intervention was from February until May 2009, and second follow-up surveys administered between July and August 2009. Karnataka had a shifted timeline due to difference in school year timing. | 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 and 5. School enrollment registers were used for random selection of students. In the case that a given grade had less than the required number of students, all students were selected.The surveys were conducted via in-person interviews by a team of trained research assistants with prior experience in administering rural household surveys in the region. Surveys were conducted in the local language, Hindi in MP and UP, and Kannada in Karnataka, and instruments pilot tested prior to use. | 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 the nature and extent of devolution, that is, in the structures created for the community to exercise local governance of schools and the amount of oversight devolved (described in The film, poster, wall-painting and calendar focused on the following information: details of roles and responsibilities of school councils; rules for selection of council members; rules for council meetings including number of mandatory meetings, minimum attendance required in meetings and record keeping of minutes; organization and funding of school accounts; right to information with respect to schools including right to obtain copies of any school record; where to complain about any problems; benefits that students in primary grades are entitled to such as cash stipend, textbooks, mid-day meal, school uniforms. The film, poster and wall-painting contained key information highlights (In addition to the information campaign treatment in the three states, there was a second treatment only in Karnataka. This was a slightly different treatment with an additional 2 minute capsule at the end of the film which showed average wages for different levels of schooling to increase awareness of the economic benefits of schooling and advocated the audience to become involved in monitoring school outcomes. All other tools were the same as in the first treatment.Campaign teams were blind to baseline and follow up surveys. The first round consisted of three visits to a GP, each visit separated by a period of two-three weeks. A key feature of the campaign was community-wide big public meetings that parents, teachers and school committee were invited to attend. On each visit, the team organized 2–3 such meetings across different neighborhoods of the GP. The target audience comprised of parents, school council members, and teachers. Separate meetings were held in low- and high- caste neighborhoods. The invitations were broadly publicized 2–3 days in advance via an audio track, the local village announcer and enlisting the primary school teachers’ help.A meeting lasted about 40 minutes during which the film was screened twice followed by opportunity to ask questions, and discussion among the audience. To ensure uniformity, research assistants followed a script, read out the introduction and were only allowed to reply to questions to which the answers were already written on the calendars. Any other questions or issues raised were not answered. The team was instructed to not participate in any discussion that took place among the community members following the film presentation. The audience was told that the information was collected from the government.After a meeting, calendars and learning assessment booklets were distributed door-to-door. Posters and wall-paintings were displayed in the school and other prominent locations.The second round was similar to the first—each GP visited thrice and visits separated by a period of three-four weeks. A focus group discussion in a small sample of treatment villages (see below) between the two intervention rounds informed the following changes based on suggestions from participants in the way meetings were organized without changing anything substantial. One change was that meetings were now mainly held at the school. If members from some caste groups or women were not willing to come to the common meeting due to village norms, then the team would hold another meeting in their neighborhood. A second change was that the film was excluded the last 2 times meetings were held. With the same film shown repeatedly, it was difficult to attract audience for the meetings. A third change was that in order to inform the illiterate audience, key information in the calendar was read aloud exactly as written to preserve uniformity. The campaign ended with 11 to 14 repeat meetings in every village cluster or GP over the two and half year period. | 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, were interviewed in the same GPs on questions posed to the focus groups, and a few additional questions on participation in school oversight. Note that the focus group was not conducted in Karnataka due to reasons of limited resources. | 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 below.To measure the impact of the campaign, for each outcome we conduct a linear difference in differences regression analysis comparing the change in intervention to the change in control group from baseline to final follow-up after adjustment of standard errors for clustering. Comparable changes between baseline and midline are reported in previous work [Focus groups and qualitative interviews are analyzed by the percentage of respondents to each question. Responses to open-ended questions are presented by main themes mentioned. | 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 from MP and UP are discussed in one subsection and from Karnataka in a following subsection. | 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, and more educated teachers (These findings can be due to increased monitoring by the communities as we find below. The extra scrutiny is likely to have affected those civil service teachers more whose motivation and effort levels were lower at baseline. Contract teachers, on the other hand, had higher effort rates, 16–22% higher attendance and 37–64% higher activity rates compared to civil service teachers at baseline [ | 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 representing grade 5 interacted with the treatment dummy variable. Results are reported accordingly, and coefficients on treatment variable are presented for grade 5 and grades 3/4 separately in the table below.We find a consistent impact mainly in the share of children acquiring mathematics competencies ( | 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 original council members remained at follow-up, while 40% were new due to routine member turnover.School councils became more functional after the campaign ( | 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 compared to MP (Impact on participation and awareness is larger on councils with higher proportion of high caste members ( | 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 effect of the second treatment, it is not significantly different from zero for the teacher effort and learning variables ( | 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 one-fourth raised it as an issue with a service provider. About 82% percent raised it with a teacher, 17% with the school committee chair and none with other council members. More than 75% went with others rather than alone to talk to this person.When asked why bigger changes did not occur in learning or teacher effort, prominent themes mentioned in the responses were “teacher is dominating,” “it is difficult to talk to the teacher,” “teacher does not listen,” and “teacher does not care.” Among low caste groups, “people are afraid to talk to the teacher” was also mentioned. When asked how the information campaign can be made more effective, the dominant response (73%) was to have more frequent meetings to disseminate information. | 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 meetings, 71% of members reported an improvement. When we asked what improved about meetings, main responses were “meetings are more frequent,” “learning is discussed,” “more members attend,” and “all are informed of when a meeting will take place.” They reported taking specific actions to monitor the schools such as checking school timings and teacher presence, and assessing grade appropriate learning levels. 76% of members reported attempting to assess learning levels in schools, 48% tried to verify teacher presence or school timings by visiting the school, and 25% directly talked to the teacher about his or her teaching. | 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 in Karnataka possibly because the states had different starting points. Baseline outcomes were much higher in Karnataka indicating greater efficiency in delivery. Impacts were in general larger or broader than those observed in the midline survey that measured impact 2–4 months after the initial intervention [In MP and UP, the impact on teacher effort was primarily for civil-service teachers who have permanent jobs and minimal incentive to work. These effects were 23% increase in teacher attendance in UP, and 16% increase in teacher attendance and 43% increase in teacher activity in MP. Among civil service teachers, the impact was greater for high caste, male and more educated teachers. Low teacher effort for these categories of teachers is a robust finding in the empirical literature for developing countries and attributed to their more powerful social status [On learning outcomes, in MP and UP a consistent result was increase in the shares of children acquiring mathematics competencies. The magnitudes of the percentage increases were much larger, due to low baseline levels of learning, compared to absolute increases in shares which were more modest in magnitude. In Karnataka, the impact occurred in mathematics competencies as in the other two states. This implies that classroom teaching was possibly impacted, although teacher effort as measured in the survey did not change in the state. Not much improvement was observed in language competencies except in UP. The modest impacts on language observed at midline were not sustained in MP and Karnataka. Although the impacts on learning, particularly in math, are larger than those observed at midline, the lack of wider or even larger impacts on learning is attributed to at least two factors. First and perhaps more important, teaching skills and teacher preparation in content and pedagogy are inadequate [In terms of process outcomes, in MP and UP school councils were more active after the campaign. Council members reported more meetings and school visits. The greater number of changes in participation and awareness outcomes of school council members in UP relative to MP can be partly due to a differences in the structure, roles and responsibilities of councils (Focus group discussions highlight the mechanisms of change and barriers that remained. First, the information provided was valued given the degree of discussion and monitoring it engendered. Second, learning was important to parents given their involvement in using the learning assessment tool and conferring with service providers. Third, the campaign spurred community action. Many parents actively brought up teaching and learning issues with teachers and councils. Change seems to have occurred through communities discussing and bringing-up issues with service providers. Two critical suggestions made by focus groups are indicative: first, organize a large meeting where the entire community is present and second, provide information regularly. Barriers to collective action are also apparent. The main obstacle to change identified was the powerful status of teachers. Teachers tend to enjoy protection from local elites [The strengths of this study are that it used a structured, practical and easily replicable intervention, had a rigorous design and broad geographic coverage. Information that becomes common knowledge can help citizens demand services from providers, especially in the context of decentralized control over public services. The study’s results build on previous work [Key features of the information program can be useful to policy-makers in designing similar programs. Empowering communities with information requires resources, but can still be cost-effective in improving service delivery. The cost of running the campaign was approximately $149 per village cluster yearly. More than 70% of India’s public education budget is teacher salaries [Changing behavior to improve learning outcomes in schools requires time. In a meta-analysis of the effectiveness of school-based management models in the US that reviewed 232 studies looking at 29 types of such programs, the number of years of program implementation was a significant predictor of the magnitude of impact on student achievement [ | 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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