The Effect of Mindfulness Yoga in Children With School Refusal: A Study Protocol for an Exploratory, Cluster-Randomized, Open, Standard Care-Controlled, Multicenter Clinical Trial.

Background: School refusal occurs in about 1-2% of young people. Anxiety and depression are considered to be the most common emotional difficulties for children who do not attend school. However, at present, no definitive treatment has been established for school refusal, although interventions such as cognitive behavioral therapy have been used. This paper reports a protocol for a cluster-randomized controlled trial of a mindfulness yoga intervention for children with school refusal. Methods: This study is a multicenter, exploratory, open cluster-randomized controlled trial. This study will recruit children aged 10-15 years with school refusal. After a 2-week baseline, participants for each cluster will be randomly assigned to one of two groups: with or without mindfulness yoga for 4 weeks. Mindfulness yoga will be created for schoolchildren for this protocol and distributed to the participants on DVD. The primary outcome is anxiety among children with school refusal using the Spence Children's Anxiety Scale-Children. Discussion: For this study, we developed a mindfulness yoga program and protocol, and examine whether mindfulness yoga can improve anxiety in children with school refusal. Our mindfulness yoga program was developed based on the opinions of children of the same age, and is a program that children can continue to do every day without getting bored. In this way, we believe that we can contribute to the smooth implementation of support to reduce the anxiety of children with school refusal, and to the reduction of the number of children who refuse to go to school.

Reducing household air pollution exposure to improve early child growth and development; a randomized control trial protocol for the "Poriborton-Extension: The CHANge trial".

BACKGROUND: Globally, household air pollution (HAP) is a leading environmental cause of morbidity and mortality. Our trial aims to assess the impact of liquefied petroleum gas (LPG) for cooking to reduce household air pollution exposure on child health outcomes, compared to usual cooking practices in Bangladesh. The primary aim is to evaluate if reduced exposure to HAP through the provision of LPG for cooking from early gestation through to age 2 improves child anthropometry, health, and neuro-cognitive developmental outcomes, compared to children exposed to emissions from usual practice. METHODS: Two-arm parallel cluster randomized controlled trial (cCRT). We will extend the intervention and follow-up of our existing "Poriborton" trial. In a subset of the original surviving participants, we will supply LPG cylinders and LPG stoves (intervention) compared to usual cooking practices and extend the follow-up to 24 months of age. The expected final sample size, for both (intervention and control) is 1854 children with follow-up to 2 years of age available for analysis. DISCUSSION: This trial will answer important research gaps related to HAP and child health and neuro-cognitive developmental outcomes. This evidence will help to understand the impact of a HAP intervention on child health to inform policies for the adoption of clean fuel in Bangladesh and other similar settings. TRIAL REGISTRATION: The Poriborton: Change trial: Household Air Pollution and Perinatal and early Neonatal mortality is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12618001214224, original trial registered on 19th July 2018, extension approved on 23rd June 2021. www.anzctr.org.au .

A study protocol of the adaptation and evaluation by means of a cluster-RCT of an integrated workplace health promotion program based on a European good practice.

BACKGROUND: An integrated workplace health promotion program (WHPP) which targets multiple lifestyle factors at different levels (individual and organizational) is potentially more effective than a single component WHPP. The aim of this study is to describe the protocol of a study to tailor a European good practice of such an integral approach to the Dutch context and to evaluate its effectiveness and implementation. METHODS: This study consists of two components. First, the five steps of the Map of Adaptation Process (MAP) will be followed to tailor the Lombardy WHP to the Dutch context. Both the employers and employees will be actively involved in this process. Second, the effectiveness of the integrated Dutch WHPP will be evaluated in a clustered randomized controlled trial (C-RCT) with measurements at baseline, 6 months and 12 months. Clusters will be composed based on working locations or units - dependent on the organization's structure and randomization within each organization takes place after baseline measurements. Primary outcome will be a combined lifestyle score. Secondary outcomes will be the separate lifestyle behaviors targeted, stress, work-life balance, need for recovery, general health, and well-being. Simultaneously, a process evaluation will be conducted. The study population will consist of employees from multiple organizations in different industry sectors. Organizations in the intervention condition will receive the integrated Dutch WHPP during 12 months, consisting of an implementation plan and a catalogue with activities for multiple lifestyle themes on various domains: 1) screening and support; 2) information and education; 3) adjustments in the social, digital or physical environment; and 4) policy. DISCUSSION: The MAP approach provides an appropriate framework to systematically adapt an existing WHPP to the Dutch context, involving both employers and employees and retaining the core elements, i.e. the catalogue with evidence-based activities on multiple lifestyle themes and domains enabling an integrated approach. The following process and effect evaluation will contribute to further insight in the actual implementation and effectiveness of the integrated WHP approach. TRIAL REGISTRATION: NTR (trialregister.nl ), NL9526. Registered on 3 June 2021.

Evaluation of a program for routine implementation of shared decision-making in cancer care: results of a stepped wedge cluster randomized trial.

BACKGROUND: Shared decision-making (SDM) is preferred by many patients in cancer care. However, despite scientific evidence and promotion by health policy makers, SDM implementation in routine health care lags behind. This study aimed to evaluate an empirically and theoretically grounded implementation program for SDM in cancer care. METHODS: In a stepped wedge design, three departments of a comprehensive cancer center sequentially received the implementation program in a randomized order. It included six components: training for health care professionals (HCPs), individual coaching for physicians, patient activation intervention, patient information material/decision aids, revision of quality management documents, and reflection on multidisciplinary team meetings (MDTMs). Outcome evaluation comprised four measurement waves. The primary endpoint was patient-reported SDM uptake using the 9-item Shared Decision Making Questionnaire. Several secondary implementation outcomes were assessed. A mixed-methods process evaluation was conducted to evaluate reach and fidelity. Data were analyzed using mixed linear models, qualitative content analysis, and descriptive statistics. RESULTS: A total of 2,128 patient questionnaires, 559 questionnaires from 408 HCPs, 132 audio recordings of clinical encounters, and 842 case discussions from 66 MDTMs were evaluated. There was no statistically significant improvement in the primary endpoint SDM uptake. Patients in the intervention condition were more likely to experience shared or patient-lead decision-making than in the control condition (d=0.24). HCPs in the intervention condition reported more knowledge about SDM than in the control condition (d = 0.50). In MDTMs the quality of psycho-social information was lower in the intervention than in the control condition (d = - 0.48). Further secondary outcomes did not differ statistically significantly between conditions. All components were implemented in all departments, but reach was limited (e.g., training of 44% of eligible HCPs) and several adaptations occurred (e.g., reduced dose of coaching). CONCLUSIONS: The process evaluation provides possible explanations for the lack of statistically significant effects in the primary and most of the secondary outcomes. Low reach and adaptations, particularly in dose, may explain the results. Other or more intensive approaches are needed for successful department-wide implementation of SDM in routine cancer care. Further research is needed to understand factors influencing implementation of SDM in cancer care. TRIAL REGISTRATION: clinicaltrials.gov, NCT03393351 , registered 8 January 2018.

Understanding and breaking the intergenerational cycle of abuse in families enrolled in routine mental health services: study protocol for a randomized controlled trial and two non-interventional trials investigating mechanisms of change within the UBICA II consortium.

BACKGROUND: Parents' mental illness (MI) and parental history of early life maltreatment (ELM) are known to be significant risk factors for poor parenting while poor parenting is a crucial mediator of the intergenerational continuity of child maltreatment. Hence, maltreatment prevention programs for families with an MI parent, which pay particular attention to experiences of ELM in the parent, are urgently needed. Parental mentalizing was previously found to mediate successful parenting. Interventions aimed at improving the parental mentalizing capacity reduced maltreatment risk in parents. The aim of the present study is to investigate the effectiveness of a mentalization-based parenting-counseling in acutely mentally ill parents currently treated at a psychiatric hospital. METHODS: Mentalization-based parenting-counseling (MB-PC) vs. enhanced standard clinical care (SCC+) will be administered in a cluster-randomized-controlled trial (RCT). Patients treated at psychiatric hospitals with children between 1.5 and 15 years will be included in the trial. MB-PC will be administered as a 12-h combined individual and group program enriched by social counseling (over a course of 5 weeks) as add-on to standard clinical care, while the control condition will be standard clinical care plus a 90-min psychoeducation workshop on positive parenting. Primary efficacy endpoint is self-reported parenting practices at follow-up. Embedded within the RCT will be two sub-studies investigating social cognition and dyadic synchrony as biobehavioral mechanisms of change. DISCUSSION: The main goal of the present study is to investigate ways to break the intergenerational continuity of maltreatment by assessing the benefits of a prevention program which aims at improving parenting in vulnerable mothers and fathers. MB-PC is a short, low-cost intervention which can be delivered by nurses and social workers and is applicable to MI patients with children with a broad range of diagnoses. If it is shown to be effective, it can be directly implemented into standard psychiatric hospital care thereby providing help to prevent child maltreatment. TRIAL REGISTRATION: German Clinical Trials Register DRKS00017398 . Registered on 5 July 2019.

Effects of a group mindfulness-based cognitive programme on smartphone addictive symptoms and resilience among adolescents: study protocol of a cluster-randomized controlled trial.

BACKGROUND: Smartphone addiction in adolescent is a significant global health issue since the last decade. Evidence has shown that the uncontrolled use of smartphone would lead to undesirable impact on their growth and development. However, evidence-based interventions to manage adolescents' smartphone addictive behaviors is lacking. The proposed study aims to examine the effect of a group mindfulness-based cognitive programme(MBCP) on resilience, smartphone behavior and addictive symptoms in young adolescents. METHODS: It is an open-label, parallel-group, cluster-randomized controlled trial with repeated measurement analysis. Four primary schools in Hong Kong will be recruited and randomly allocated in a ratio of 1:1 to the intervention/control group. A convenience sample of 240 class level 5 primary school students, 60 from each school, will be recruited. Participants in the intervention group will receive a 12-week MBCP which comprises 90-minute supervised practice at school and daily home practice. Resilience will be measured by Connor-Davidson Resilience Scale - 25 (Chinese version); smartphone behavior will be represented by time spent/day using the smartphone and types of functions used; addictive symptoms will be measured by Smartphone Addiction Scale-Short Version (Chinese Version). Baseline assessment(T0) will be conducted before the intervention starts. Post-tests will be conducted in weeks 4, 8, 12 of the intervention, and 3 months follow-up. Intention-to-Treat analysis will be applied to the variables. Generalized Estimating Equation model will be used to compare differences in resilience scores, smartphone behavior and addiction scores between and within groups, adjusted for socio-demographic factors. P < 0.05 with two-tailed test will be regarded as significance. DISCUSSION: It is expected that adolescents will demonstrate better resilience and lesser smartphone addictive symptoms after joining the MBCP. The study will be the first provided empirical evidence to support the promising application of MBCP to manage smartphone use among adolescents. It introduces community stakeholders including community nurses a non-invasive and simple-to-administer intervention to tackle problematic smartphone use among adolescent clients. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR2000033273, Registered on 26 May 2020.

Association of antenatal vitamin B complex supplementation with neonatal vitamin B12 status: evidence from a cluster randomized controlled trial.

PURPOSE: Evidence about the effect of maternal vitamin B12 supplementation on offspring's vitamin B12 status is limited. The present interventional study sought to evaluate the association of antenatal vitamin B complex supplementation with neonatal vitamin B12 status. METHODS: In an ongoing cluster randomized controlled trial conducted in three rural counties in northwest China, pregnant women < 20 weeks of gestation were randomized to three treatment groups: blank control, iron supplements, or vitamin B complex supplements. All women were administered folic acid supplements during the periconceptional period. In a sub-study, we collected cord blood samples of 331 participants from the control or vitamin B complex groups in the Xunyi county from January 2017 to December 2017. Plasma concentrations of folate, vitamin B12, and homocysteine were measured. Linear mixed models with a random intercept for cluster were used to compare biochemical indexes between groups after controlling for covariates. RESULTS: Compared with newborns whose mothers were in the control group, newborns of the vitamin B complex-supplemented women had significantly higher cord plasma vitamin B12 (P = 0.001) and lower homocysteine concentrations (P = 0.043). The association of antenatal vitamin B complex supplementation with cord blood vitamin B12 concentrations appeared to be more pronounced among newborns with high folate status than those with low folate status (Pinteraction = 0.060). CONCLUSIONS: Maternal vitamin B complex supplementation during pregnancy was associated with better neonatal vitamin B12 status in rural northwest China.

Study protocol of a cluster randomized controlled trial of strategies to increase antenatal iron and folic acid supplementation and malaria prophylaxis in rural south-central Côte d'Ivoire.

BACKGROUND: Coverage of antenatal iron and folic acid supplementation (IFAS) and intermittent preventive treatment of malaria in pregnancy (IPTp) remains low in many countries. Evidence on the most effective ways to increase both IFASIPTp is mixed overall, with only few studies directly identifying cost-effective ways to increase coverage of both interventions. The proposed study aims to assess the cost, impact and relative cost-effectiveness of two complementary strategies of increasing IFAS and malaria chemoprophylaxis coverage among pregnant women relative to the current default system in a rural low-income setting of sub-Saharan Africa. METHODS/DESIGN: This study will be carried out in the Taabo health and demographic surveillance system (HDSS) in south-central Côte d'Ivoire. This is a cluster-randomized trial targeting 720 consenting pregnant women aged ≥15 years. The 118 clusters constituting the Taabo HDSS monitoring area will be randomly allocated to one of the following three groups with equal probability: a control group, an information only group, and an information plus home delivery group. To assess the relative effectiveness of each strategy, we will conduct an endline survey within the first 2 weeks after delivery. The primary outcomes of the trial will be maternal post-partum anaemia and malaria infection. Anaemia will be assessed using HEMOCUE devices; malaria infections will be assessed using standard rapid diagnostic tests named CareStart™ Malaria Pf (HRP2) Ag RDT (Multi Kit with capped lancet and inverted cup specimen transfer device). Other outcomes will include self-reported adherence to supplementation and malaria chemoprophylaxis, as well as miscarriages, stillbirths and low birth weight deliveries. DISCUSSION: This study will assess the cost-effectiveness of two alternative strategies to increase antenatal IFAS and malaria chemoprophylaxis coverage among pregnant women in rural Côte d'Ivoire and similar settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT04250428 ; Registered 31 January 2020.

A cluster randomized controlled trial on a multifaceted implementation strategy to promote integrated palliative care in COPD: study protocol of the COMPASSION study.

BACKGROUND: Despite the urgent need for palliative care for patients with advanced chronic obstructive pulmonary disease (COPD), it is not yet daily practice. Important factors influencing the provision of palliative care are adequate communication skills, knowing when to start palliative care and continuity of care. In the COMPASSION study, we address these factors by implementing an integrated palliative care approach for patients with COPD and their informal caregivers. METHODS: An integrated palliative care intervention was developed based on existing guidelines, a literature review, and input from patient and professional organizations. To facilitate uptake of the intervention, a multifaceted implementation strategy was developed, comprising a toolbox, (communication) training, collaboration support, action planning and monitoring. Using a hybrid effectiveness-implementation type 2 design, this study aims to simultaneously evaluate the implementation process and effects on patient, informal caregiver and professional outcomes. In a cluster randomized controlled trial, eight hospital regions will be randomized to receive the integrated palliative care approach or to provide care as usual. Eligible patients are identified during hospitalization for an exacerbation using the Propal-COPD tool. The primary outcome is quality of life (FACIT-Pal) at 6 months. Secondary outcome measures include spiritual well-being, anxiety and depression, unplanned healthcare use, informal caregiver burden and healthcare professional's self-efficacy to provide palliative care. The implementation process will be investigated by a comprehensive mixed-methods evaluation assessing the following implementation constructs: context, reach, dose delivered, dose received, fidelity, implementation level, recruitment, maintenance and acceptability. Furthermore, determinants to implementation will be investigated using the Consolidated Framework for Implementation Research. DISCUSSION: The COMPASSION study will broaden knowledge on the effectiveness and process of palliative care integration into COPD-care. Furthermore, it will improve our understanding of which strategies may optimize the implementation of integrated palliative care. TRIAL REGISTRATION: Netherlands Trial Register (NTR): NL7644 . Registration date: April 7, 2019.

Effectiveness of community-based folate-oriented tertiary interventions on incidence of fetus and birth defects: a protocol for a single-blind cluster randomized controlled trial.

BACKGROUND: Birth defects are the main cause of fetal death, infant mortality and morbidity worldwide. However, the etiology of birth defects remains largely unknown. Maternal folate status during periconception plays an important role in organogenesis and folic acid supplement reduces the risk of neural tube defects, congenital heart diseases, and several other birth defects. This trial seeks to evaluate the effectiveness of folate-oriented tertiary interventions during periconception on the incidence of fetus and birth defects. METHODS: This is a single-blind, two-arm cluster randomized controlled trial in Shanghai, China. Eligible women from 22 clusters are recruited at pre-pregnancy physical examinations clinical settings. Compared to the routine perinatal care group (control arm), folate-oriented tertiary interventions will be provided to the intervention arm. The core interventions consist of assessments of folate status and metabolism, folate intake guidance, and re-evaluation of folate status to ensure red blood cell folate level above 400 ng/ml (906 nmol/L) before pregnancy. Screening and consulting of fetus and birth defects, and treatments of birth defects during pregnancy and afterward will be provided to both arms. The primary outcome is a composite incidence of fetus defects, stillbirth, and neonatal birth defects identified from the confirmation of pregnancy to 28 days after birth. Secondary outcomes include maternal and offspring adverse complications and cost-effectiveness of folate-oriented tertiary interventions. This protocol adheres to the SPIRIT Checklist. DISCUSSION: To achieve the recommended folate status before or during pregnancy is still a challenge worldwide. This community-based cluster-randomized controlled intervention trial will evaluate the effectiveness of a package of interventions aiming at achieving recommended maternal folate status covering pre- and during pregnancy in reducing fetus and birth defects. Our study has the potential to improve the community-based practice of reducing modifiable risk factors of disease and improving primary prevention of the defects in China. The procedures would formulate the policy on folic acid supplementation during periconception against birth defects in primary care settings. TRIAL REGISTRATION: Clinical Trial Registry, NCT03725878 . Prospectively registered on 31 October 2018.

Efficacy of an iron-fortified infant cereal to reduce the risk of iron deficiency anemia in young children in East Cameroon.

Complementary foods in Africa are often poor sources of bioavailable iron. We assessed the efficacy of iron-fortified wheat-based infant cereal (IC) to reduce the risk of iron deficiency anemia in children aged 18-59 months in Cameroon. A 6-month double-blind, cluster-randomized controlled trial was conducted in 2017 among anemic (hemoglobin 7-11 g/dl) but otherwise healthy children. In conjunction with usual diet, children received two 50 g servings/day of a standard, micronutrient-fortified IC (providing 3.75 mg iron/serving; n = 106) or the same IC without iron fortification (n = 99). Anthropometric measurements, blood sampling, and systematic deworming were performed in all children at baseline (pre-intervention), 3, and 6 months. Mean hemoglobin, ferritin adjusted for C-reactive protein (CRP), serum iron, transferrin saturation, prevalence of anemia, iron deficiency, and iron deficiency anemia as well as anthropometrics were compared between the groups at baseline, 3, and 6 months. Compared to the control group, children consuming the iron-fortified IC had significantly higher baseline-adjusted mean hemoglobin (10.0 ± 1.8 vs. 9.7 ± 1.4 g/dl, respectively; p = .023), ferritin adjusted for CRP (16.1 ± 8.3 vs. 9.5 ± 7.5 µg/L, p < .001), serum iron (14.5 ± 3.9 vs. 11.2 ± 4.4 µg/dl; p < .001), and transferrin saturation (19.0 ± 17.4 vs. 10.7 ± 12.5%; p Ë‚ .001) at 6 months. The prevalence of anemia, iron deficiency, and iron deficiency anemia at 6 months decreased by a larger extent in the iron-fortified group versus controls (all p < .01). In addition, at 6 months, children in the iron-fortified group demonstrated higher weight-for-age z-scores (p = .016) compared to the control group. Wheat-based IC fortified with 7.5 mg ferrous fumarate administered daily for 6 months improved iron and nutritional status and decreased the prevalence of iron deficiency anemia in children aged 18-59 months in Salapoumbé, Cameroon.

Effect of household water treatment with chlorine on diarrhea among children under the age of five years in rural areas of Dire Dawa, eastern Ethiopia: a cluster randomized controlled trial.

BACKGROUND: Diarrheal disease is a leading cause of child mortality and morbidity worldwide. Household water treatment with chlorine significantly reduces morbidity due to waterborne diseases. However, the effect of point-of-use (POU) water treatment in improving the quality of water in areas where POU is not provided free of charge and the effectiveness of home visits in inspiring household members to use POU regularly have not been studied. The objective of this study was to evaluate the effectiveness of drinking water disinfection by chlorination on diarrheal disease reduction among children under the age of 5 years in rural eastern Ethiopia. METHODS: A cluster randomized controlled trial was carried out in rural Dire Dawa from October 2018 through January 2019. The 405 households were randomized to intervention and control arms and intervention materials were distributed after conducting a baseline survey. This trial evaluated the effectiveness of household drinking water disinfection by chlorination in reducing incidence of diarrhea among children under the age of 5 years. Intervention households received 1.2% sodium hypochlorite with demonstration of its proper use. Participants in the control households continued with their usual habits of water collection and water storage. Generalized estimation equation (GEE) with log link Poisson distribution family and exchangeable correlation matrix was used to compute crude incidence rate ratio (IRR), adjusted IRR and the corresponding 95% confidence intervals. RESULTS: In the intervention households, in total, 281 cases of diarrhea were documented (8.7 cases per 100 person-weeks observation); in the control households, in total 446 cases of diarrhea were documented (13.8 cases per 100 person-weeks observation). A 36.0% (adjusted IRR = 0.64, 95% CI: 0.57-0.73) reduction in incidence of diarrhea was observed in the intervention arm when compared with the control arm. The highest and the lowest reductions were obtained in children of age ranges 1 to 2 years and 3 to 4 years, 42.7 and 30.4%, respectively. Adherence to the intervention was 81.3% as measured by free residual chlorine test. CONCLUSIONS: In rural areas where diarrhea is the second leading cause of morbidity, water chlorination at the household level using liquid bleach considerably reduced episodes of diarrhea among children under the age of 5 years. Therefore, chlorinating drinking water at the household level may be a valuable interim solution for reducing the incidence of diarrheal diseases until potable water is made accessible to the majority of the population in Dire Dawa Administration and other Ethiopian communities. TRIAL REGISTRATION: PACTR, PACTR201807815961394. Registered 16 July 2018, www.pactr.org.

Meridian Cuffing Exercises Improved Functional Fitness and Cardiopulmonary Functioning of Community Older Adults.

This study was aimed to test the effects of a meridian cuffing exercise, the Healthy Beat Acupunch (HBA) regimen, on the functional fitness and cardiopulmonary functioning of community older adults. A single-blind, cluster randomized controlled trial was conducted. We randomly allocated eight community care centers to the intervention or control group and recruited 228 participants who completed the study (intervention: four centers, n = 111; control: four centers, n = 117). The intervention group underwent a 40-min session of HBA regimen 3 times per week for 6 months. Functional fitness and cardiopulmonary functioning were assessed at baseline, 3 months, and 6 months of the intervention. The intervention group demonstrated significantly greater improvements in functional fitness and cardiopulmonary functioning than the control group between baseline and either 3 months or 6 months. We suggest that activities designed to promote health among community older adults include acupunch exercises.

Stratified exercise therapy compared with usual care by physical therapists in patients with knee osteoarthritis: A randomized controlled trial protocol (OCTOPuS study).

OBJECTIVES: Knee osteoarthritis (OA) is characterized by its heterogeneity, with large differences in clinical characteristics between patients. Therefore, a stratified approach to exercise therapy, whereby patients are allocated to homogeneous subgroups and receive a stratified, subgroup-specific intervention, can be expected to optimize current clinical effects. Recently, we developed and pilot tested a model of stratified exercise therapy based on clinically relevant subgroups of knee OA patients that we previously identified. Based on the promising results, it is timely to evaluate the (cost-)effectiveness of stratified exercise therapy compared with usual, "nonstratified" exercise therapy. METHODS: A pragmatic cluster randomized controlled trial including economic and process evaluation, comparing stratified exercise therapy with usual care by physical therapists (PTs) in primary care, in a total of 408 patients with clinically diagnosed knee OA. Eligible physical therapy practices are randomized in a 1:2 ratio to provide the experimental (in 204 patients) or control intervention (in 204 patients), respectively. The experimental intervention is a model of stratified exercise therapy consisting of (a) a stratification algorithm that allocates patients to a "high muscle strength subgroup," "low muscle strength subgroup," or "obesity subgroup" and (b) subgroup-specific, protocolized exercise therapy (with an additional dietary intervention from a dietician for the obesity subgroup only). The control intervention will be usual best practice by PTs (i.e., nonstratified exercise therapy). Our primary outcome measures are knee pain severity (Numeric Rating Scale) and physical functioning (Knee Injury and Osteoarthritis Outcome Score subscale daily living). Measurements will be performed at baseline, 3-month (primary endpoint), 6-month (questionnaires only), and 12-month follow-up, with an additional cost questionnaire at 9 months. Intention-to-treat, multilevel, regression analysis comparing stratified versus usual care will be performed. CONCLUSION: This study will demonstrate whether stratified care provided by primary care PTs is effective and cost-effective compared with usual best practice from PTs.

Effects of Tai Chi Yunshou exercise on community-based stroke patients: a cluster randomized controlled trial.

BACKGROUD: Tai Chi Chuan was used for stroke survivors with balance impairments. However, even a short-form of Tai Chi Chuan includes forms that make the exercise challenging for the stroke survivors. Tai Chi Yunshou (wave hands in the cloud) is the "mother" form and the fundamental form of all Tai Chi Chuan styles, which is considered more suitable and feasible for stroke survivors with balance impairments. So this study was designed to evaluate the effects of Tai Chi Yunshou exercise on community-based stroke patients with balance dysfunctions. METHODS: A total of 250 participants from 10 community health centers (5 per arm) were selected and randomly allocated into Tai Chi Yunshou exercise group (TC group) or a balance rehabilitation training group (control group) in an equal ratio. Participants in the TC group were received Tai Chi Yunshou exercise training five times per week for 12 weeks and those in control group were received balance rehabilitation training five times per week for 12 weeks. Outcome assessments including Berg Balance Scale (BBS), Time up to go test (TUGT), Modified Barthel Index (MBI) were measured at baseline, 4 weeks, 8 weeks, 12 weeks and followed-up 6 weeks (18 weeks), 12 weeks (24 weeks). Intention-to-treat analysis was performed. Analysis of variance of repeated measures was used to assess between-group differences. RESULTS: A total of 244 participants, 120 in the TC group and 124 in the rehabilitation group, were included in final analysis. There was no siginificant difference in Tai Chi Yunshou and balance rehabilitation training on the improvement of balance ability and mobility (P = 0.531 and P = 0.839, respectively) after adjustment for baseline. However, there was significant difference between two groups on improvement of motor funtion (P = 0.022), fear of falling (P < 0.001) and depression (P = 0.035) for the post stroke patients. No adverse events were reported during the study. CONCLUSION: Tai Chi Yunshou and balance rehabilitation training led to improved balance ability and functional mobility, and both are suitable community-based programs that may benefit for stroke recovery and community reintegration. Our data demonstrated that a 12-week Tai Chi Yunshou intervention was more effective in motor function, fear of falling and depression than balance rehabilitation training. Future studies examining the effectiveness of Tai Chi Yunahou as a balance ability improvement strategy for community-dwelling survivors of stroke are recommended. TRIAL REGISTRATION: Chinese Clinical Trail Registry: ChiCRT-TRC-13003641. Registration date: 22 August, 2013.

Aged care clinical mentoring model of change in nursing homes in China: study protocol for a cluster randomized controlled trial.

BACKGROUND: Residents living in nursing homes usually have complex healthcare needs and require a comprehensive care approach to identifying and meeting their care needs. Suboptimal quality of care is reported in nursing homes and is associated with the poor health and well-being of the residents, the burden on acute care hospitals and the high costs of healthcare for the government. The aim of this study is to test the hypothesis that an Aged Care Clinical Mentoring Model will create and sustain evidence-based quality improvement in priority areas and will be cost-effective in nursing homes in Hunan Province, China. METHODS: A cluster randomized controlled trial will be applied to the study. Fourteen nursing homes will be randomly allocated to either the intervention group (n = 7) or the control group (n = 7). Forty staff will be recruited from each nursing home and the estimated sample size will be 280 staff in each group. The intervention includes a structured, evidence-based quality improvement education program for staff to facilitate knowledge translation in evidence-based quality improvement targeting urinary incontinence, pressure injury and falls prevention. The primary outcomes are nursing homes' capacity to create and sustain quality improvement, staff perceptions of person-centered care, self-reported quality of care by residents and selected quality indicators at 12 months follow-up adjusted for baseline value. Secondary outcomes are residents' quality of life, residents' unplanned admissions to acute care hospitals, quality of care reported by staff, staff job satisfaction and staff intention to leave adjusted for baseline value. A mixed linear regression model will be adopted to compare the significant differences between groups over a 12-month period. DISCUSSION: Although the Aged Care Clinical Mentoring Model has been tested as an effective model to bring positive changes in nursing homes in a high-income country, factors affecting the adaptation of the model in nursing homes in low- and middle-income countries are unknown. The carefully planned intervention protocol enables the project team to consider enablers and barriers when adapting the Model. Therefore, strategies and resources will be in place to manage challenges while demonstrating best practice in this study. TRIAL REGISTRATION: Prospectively registered via Chinese Clinical Trial Registry (ChiCTR), ChiCTR-IOC-17013109 , Registered on 25 October 2017.

Evaluation of a program for routine implementation of shared decision-making in cancer care: study protocol of a stepped wedge cluster randomized trial.

BACKGROUND: Shared decision-making (SDM) has become increasingly important in health care. However, despite scientific evidence, effective implementation strategies, and a prominent position on the health policy agenda, SDM is not widely implemented in routine practice so far. Therefore, we developed a program for routine implementation of SDM in oncology by conducting an analysis of the current state and a needs assessment in a pilot study based on the Consolidated Framework for Implementation Research (CFIR). Based on these results, the main aim of our current study is to evaluate the process and outcome of this theoretically and empirically grounded multicomponent implementation program designed to foster SDM in routine cancer care. METHODS: We use a stepped wedge design, a variant of the cluster randomized controlled trial. The intervention to be implemented is SDM. Three participating clinics of one comprehensive cancer center will be randomized and receive the multicomponent SDM implementation program in a time-delayed sequence. The program consists of the following strategies: (a) SDM training for health care professionals, (b) individual coaching for physicians, (c) patient activation strategy, (d) provision of patient information material and decision aids, (e) revision of the clinics' quality management documents, and (f) critical reflection of current organization of multidisciplinary team meetings. We will conduct a mixed methods outcome and process evaluation. The outcome evaluation will consist of four measurement points. The primary outcome is adoption of SDM, measured by the 9-item Shared Decision Making Questionnaire. A range of other implementation outcomes will be assessed (i.e., acceptability, readiness for implementing change, appropriateness, penetration). The implementation process will be evaluated using stakeholder interviews and field notes. This will allow adapting interventions if necessary. DISCUSSION: This study is the first large study on routine implementation of SDM conducted in German cancer care. We expect to foster implementation of SDM at the enrolled clinics. Insights gained from this study, using a theoretically and empirically grounded approach, can inform other SDM implementation studies and health policy developments, both nationally and internationally. TRIAL REGISTRATION: clinicaltrials.gov, NCT03393351 . Registered 8 January 2018.

Iron Fortified Complementary Foods Containing a Mixture of Sodium Iron EDTA with Either Ferrous Fumarate or Ferric Pyrophosphate Reduce Iron Deficiency Anemia in 12- to 36-Month-Old Children in a Malaria Endemic Setting: A Secondary Analysis of a Cluster-Randomized Controlled Trial.

Iron deficiency anemia (IDA) is a major public health problem in sub-Saharan Africa. The efficacy of iron fortification against IDA is uncertain in malaria-endemic settings. The objective of this study was to evaluate the efficacy of a complementary food (CF) fortified with sodium iron EDTA (NaFeEDTA) plus either ferrous fumarate (FeFum) or ferric pyrophosphate (FePP) to combat IDA in preschool-age children in a highly malaria endemic region. This is a secondary analysis of a nine-month cluster-randomized controlled trial conducted in south-central Côte d'Ivoire. 378 children aged 12-36 months were randomly assigned to no food intervention (n = 125; control group), CF fortified with 2 mg NaFeEDTA plus 3.8 mg FeFum for six days/week (n = 126; FeFum group), and CF fortified with 2 mg NaFeEDTA and 3.8 mg FePP for six days/week (n = 127; FePP group). The outcome measures were hemoglobin (Hb), plasma ferritin (PF), iron deficiency (PF < 30 µg/L), and anemia (Hb < 11.0 g/dL). Data were analyzed with random-effect models and PF was adjusted for inflammation. The prevalence of Plasmodium falciparum infection and inflammation during the study were 44-66%, and 57-76%, respectively. There was a significant time by treatment interaction on IDA (p = 0.028) and a borderline significant time by treatment interaction on iron deficiency with or without anemia (p = 0.068). IDA prevalence sharply decreased in the FeFum (32.8% to 1.2%, p < 0.001) and FePP group (23.6% to 3.4%, p < 0.001). However, there was no significant time by treatment interaction on Hb or total anemia. These data indicate that, despite the high endemicity of malaria and elevated inflammation biomarkers (C-reactive protein or α-1-acid-glycoprotein), IDA was markedly reduced by provision of iron fortified CF to preschool-age children for 9 months, with no significant differences between a combination of NaFeEDTA with FeFum or NaFeEDTA with FePP. However, there was no overall effect on anemia, suggesting most of the anemia in this setting is not due to ID. This trial is registered at clinicaltrials.gov (NCT01634945).

Good epidemiological practice: a narrative review of appropriate scientific methods to evaluate the impact of antimicrobial stewardship interventions.

AIMS: In this narrative review, we provide a framework for assessing the quality of evidence provided by studies investigating antimicrobial stewardship (AMS) interventions, and inform the design and planning stage for future AMS evaluation studies to determine the best strategies to keep antimicrobial resistance at bay. SOURCES: Cochrane/Pubmed. CONTENT: As AMS is mostly applied in a complex, real-world setting, bias and random time effects can jeopardize the validity of causal inference. The most important risks include simultaneously implemented infection prevention strategies and regression to the mean. Inclusion of homogeneous intervention and control arms, through randomization of the intervention, can limit these risks. However, contamination can play an important role for AMS; therefore, randomization at cluster-level, instead of randomization at individual-level, is recommended. It can be challenging to identify enough representative clusters, and implementation of a cluster-RCT (cRCT) can be costly. Controlled interrupted time series (ITS) design has a high validity as well, and is relatively straightforward to implement, although time-varying confounding should be considered. Independent of the study design, it is crucial to include multiple process, clinical outcome, microbiological and financial measures, to be able to detect possible, unintended consequences. IMPLICATIONS: Future studies assessing the impact of new AMS strategies should produce compelling evidence by opting for cRCTs, or ITS including a control arm. Furthermore, a holistic view of intended and unintended consequences should be reported, and a detailed process evaluation should be provided to adequately inform implementation of successful AMS strategies to battle the rising burden of AMR.

A cluster-randomized evaluation of an intervention to increase skilled birth attendant utilization in mid- and far-western Nepal.

Skilled birth attendant (SBA) utilization is low in remote and rural areas of Nepal. We designed and implemented an evaluation to assess the effectiveness of a five-component intervention that addressed previously identified barriers to SBA services in mid- and far-western Nepal. We randomly and equally allocated 36 village development committees with low SBA utilization among 1-year intervention and control groups. The eligible participants for the survey were women that had delivered a baby within the past 12 months preceding the survey. Implementation was administered by trained health volunteers, youth groups, mothers' groups and health facility management committee members. Post-intervention, we used difference-in-differences and mixed-effects regression models to assess and analyse any increase in the utilization of skilled birth care and antenatal care (ANC) services. All analyses were done by intention to treat. Our trial registration number was ISRCTN78892490 (http://www.isrctn.com/ISRCTN78892490). Interviewees included 1746 and 2098 eligible women in the intervention and control groups, respectively. The 1-year intervention was effective in increasing the use of skilled birth care services (OR = 1.57; CI 1.19-2.08); however, the intervention had no effect on the utilization of ANC services. Expanding the intervention with modifications, e.g. mobilizing more active and stable community groups, ensuring adequate human resources and improving quality of services as well as longer or repeated interventions will help achieve greater effect in increasing the utilization of SBA.