Interventions for promoting participation in shared decision-making for children with cancer.

BACKGROUND: This is an update of the Cochrane systematic review of shared decision-making (SMD) making published in 2013. Children's rights to have their views heard in matters that affect their lives are now well established since the publication of the UN Convention treaty (1989). Children with cancer generally prefer to be involved in decision-making and consider it important that they have the opportunity to take part in decision-making concerning their health care, even in end-of-life decisions. There is considerable support for involving children in healthcare decision-making at a level commensurate with their experience, age and abilities. Thus, healthcare professionals and parents need to know how they should involve children in decision-making and what interventions are most effective in promoting SDM for children with cancer. OBJECTIVES: To examine the effects of SDM interventions on the process of SDM for children with cancer who are aged four to 18 years. SEARCH METHODS: We searched the following sources for the review: Cochrane Central Register of Controlled Studies (CENTRAL) (the Cochrane Library 2016, Issue 1); PubMed (NLM) (1946 to February 2016); Embase (Ovid) (1974 to February 2016); CINAHL (EBSCO) (1982 to February 2016); ERIC (ProQuest) (1966 to February 2016); PsycINFO (EBSCO) (1806 to February 2016); BIOSIS (Thomson Reuters) (1980 to December 2009 - subscription ceased at that date); ProQuest Dissertations and Theses (1637 to February 2016); and Sociological Abstracts (ProQuest) (1952 to February 2016). In addition we searched the reference lists of relevant articles and review articles and the following conference proceedings (2005 up to and including 2015): American Academy on Communication in Healthcare (AACH), European Society for Medical Oncology (ESMO), European CanCer Organisation (ECCO), European Association for Communication in Healthcare (EACH), International Conference on Communication in Healthcare (ICCH), International Shared Decision Making Conference (ISDM), Annual Conference of the International Society for Paediatric Oncology (SIOP) and Annual Scientific Meeting of the Society for Medical Decision Making (SMDM). We scanned the ISRCTN (International Standard Randomised Controlled Trial Number) register and the National Institutes of Health (NIH) Register for ongoing trials on 29 February 2016. SELECTION CRITERIA: For this update, we included randomised controlled trials (RCTs) and controlled clinical trials (CCTs) of SDM interventions for children with cancer aged four to 18 years. The types of decisions included were: treatment, health care and research participation decisions. The primary outcome was SDM as measured with any validated scale. DATA COLLECTION AND ANALYSIS: Two review authors undertook the searches, and three review authors independently assessed the studies obtained. We contacted study authors for additional information. MAIN RESULTS: No studies met the inclusion criteria, and hence no analysis could be undertaken. AUTHORS' CONCLUSIONS: No conclusions can be made on the effects of interventions to promote SDM for children with cancer aged four to 18 years. This review has highlighted the dearth of high-quality quantitative research on interventions to promote participation in SDM for children with cancer. There are many potential reasons for the lack of SDM intervention studies with children. Attitudes towards children's participation are slowly changing in society and such changes may take time to be translated or adopted in healthcare settings. The priority may be on developing interventions that promote children's participation in communication interactions since information-sharing is a prerequisite for SDM. Restricting this review to RCTs was a limitation and extending the review to non-randomised studies (NRS) may have produced more evidence. For this update, we included only RCTs and CCTs. Clearly more research is needed.

Low bacterial diet versus control diet to prevent infection in cancer patients treated with chemotherapy causing episodes of neutropenia.

BACKGROUND: Neutropenia is a potentially serious side effect of chemotherapy and a major risk factor for infection, which can be life-threatening. It has been hypothesised that a low bacterial diet (LBD) can prevent infection and (infection-related) mortality in cancer patients receiving chemotherapy that causes episodes of neutropenia, but much remains unclear. This review is an update of a previously published Cochrane review. OBJECTIVES: The primary objective of this review was to determine the efficacy of an LBD versus a control diet in preventing infection and in decreasing (infection-related) mortality in adult and paediatric cancer patients receiving chemotherapy that causes episodes of neutropenia. Secondary objectives were to assess time to first febrile episode, need for empirical antibiotic therapy, diet acceptability and quality of life. SEARCH METHODS: We searched the following electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL) (2015, Issue 4), the Database of Abstracts of Reviews of Effects (DARE) (2015, Issue 4), PubMed (from 1946 to 4 May 2015), EMBASE (from 1980 to 4 May 2015) and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (from 1981 to 4 May 2015).In addition, we searched the reference lists of relevant articles and conference proceedings of American Society of Hematology (ASH; from 2000 to 2015), European Bone Marrow Transplantation (EBMT; from 2000 to 2015), Oncology Nurses Society (ONS; from 2000 to 2015), International Society for Paediatric Oncology (SIOP; from 2000 to 2014), Multinational Association of Supportive Care in Cancer (MASCC; from 2000 to 2015), American Society of Clinical Oncology (ASCO; from 2000 to 2015), Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC; from 2000 to 2015), European Society for Clinical Nutrition and Metabolism (ESPEN; from 2000 to 2015), American Society for Parenteral and Enteral Nutrition (ASPEN; from 2000 to 2015) and European Hematology Association (EHA; from 2000 to 2015). In May 2015, we scanned the National Institutes of Health Register via clinicaltrials.gov and the International Standard Randomised Controlled Trial Number (ISRCTN) Register (www.controlled-trials.com). SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing use of an LBD versus a control diet with regard to infection rate, (infection-related) mortality, time to first febrile episode, need for empirical antibiotic therapy, diet acceptability and quality of life in adult and paediatric cancer patients receiving chemotherapy causing episodes of neutropenia. DATA COLLECTION AND ANALYSIS: Two review authors independently performed study selection, 'Risk of bias' assessment and data extraction. We performed analyses according to the guidelines of the Cochrane Handbook for Systematic Reviews of Interventions. MAIN RESULTS: In the original version of this review, we identified three RCTs that assessed different intervention and control diets in 192 participants (97 randomised to intervention diet; 95 to control diet) with different types of malignancies. For the update, we identified no eligible new studies. Co-interventions (e.g. protective environment, antimicrobial prophylaxis, central venous catheter care, oral care, hygiene practices, colony-stimulating factors) and outcome definitions also differed between studies. In all included studies, it was standard policy to give empirical antibiotics (and sometimes also antimycotics) to (some of) the participants diagnosed with an infection. Two studies included adults and one study included children. In all studies, only a scant description of treatment regimens was provided. All studies had methodological limitations. Pooling of results of included studies was not possible. In two individual studies, no statistically significant differences in infection rate were identified between intervention and control diets; another study showed no significant differences between treatment groups in the number of chemotherapy cycles with an infection. None of the studies mentioned infection-related mortality, but in one study, no significant difference in overall survival was observed between treatment groups. Time from onset of neutropenia to fever, duration of empirical antibiotics and antimycotics, diet acceptability (i.e. following the diet easily and following the diet throughout all chemotherapy cycles) and quality of life were all evaluated by only one study; for all outcomes, no statistically significant differences between treatment arms were identified. AUTHORS' CONCLUSIONS: At the moment, no evidence from individual RCTs in children and adults with different malignancies underscores use of an LBD for prevention of infection and related outcomes. All studies differed with regard to co-interventions, outcome definitions and intervention and control diets. As pooling of results was not possible, and as all studies had serious methodological limitations, we could reach no definitive conclusions. It should be noted that 'no evidence of effect', as identified in this review, is not the same as 'evidence of no effect'. On the basis of currently available evidence, we are not able to provide recommendations for clinical practice. Additional high-quality research is needed.

Validation of search filters for identifying pediatric studies in PubMed.

OBJECTIVE: To identify and validate PubMed search filters for retrieving studies including children and to develop a new pediatric search filter for PubMed. STUDY DESIGN: We developed 2 different datasets of studies to evaluate the performance of the identified pediatric search filters, expressed in terms of sensitivity, precision, specificity, accuracy, and number needed to read (NNR). An optimal search filter will have a high sensitivity and high precision with a low NNR. RESULTS: In addition to the PubMed Limits: All Child: 0-18 years filter (in May 2012 renamed to PubMed Filter Child: 0-18 years), 6 search filters for identifying studies including children were identified: 3 developed by Kastner et al, 1 developed by BestBets, one by the Child Health Field, and 1 by the Cochrane Childhood Cancer Group. Three search filters (Cochrane Childhood Cancer Group, Child Health Field, and BestBets) had the highest sensitivity (99.3%, 99.5%, and 99.3%, respectively) but a lower precision (64.5%, 68.4%, and 66.6% respectively) compared with the other search filters. Two Kastner search filters had a high precision (93.0% and 93.7%, respectively) but a low sensitivity (58.5% and 44.8%, respectively). They failed to identify many pediatric studies in our datasets. The search terms responsible for false-positive results in the reference dataset were determined. With these data, we developed a new search filter for identifying studies with children in PubMed with an optimal sensitivity (99.5%) and precision (69.0%). CONCLUSION: Search filters to identify studies including children either have a low sensitivity or a low precision with a high NNR. A new pediatric search filter with a high sensitivity and a low NNR has been developed.

Low bacterial diet versus control diet to prevent infection in cancer patients treated with chemotherapy causing episodes of neutropenia.

BACKGROUND: Neutropenia is a potentially serious side effect of chemotherapy and a major risk factor for infections, which can be life-threatening. It has been hypothesised that a low bacterial diet (LBD) can prevent the occurrence of infections and (infection-related) mortality in cancer patients receiving chemotherapy causing episodes of neutropenia, but much remains unclear. OBJECTIVES: The primary objective was to determine the efficacy of an LBD versus a control diet in preventing the occurrence of infection and to decrease (infection-related) mortality in adult and paediatric cancer patients receiving chemotherapy causing episodes of neutropenia. Secondary objectives were to assess the time to first febrile episode, the need for empirical antibiotic therapy, diet acceptability and quality of life. SEARCH METHODS: We searched the following electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, issue 3 2011), Database of Abstracts of Reviews of Effects (DARE) (The Cochrane Library, issue 3 2011), PubMed (from 1946 to 20 October 2011), EMBASE (from 1980 to 20 October 2011) and CINAHL (from 1981 to 20 October 2011). In addition, we searched several conference proceedings (from 2000 to either 2010 or 2011) and reference lists of relevant articles. To identify ongoing trials we contacted researchers working on this topic and we scanned the National Institute of Health Register and the ISRCTN Register (www.controlled-trials.com; searched May 2012). SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing the use of an LBD with a control diet with regard to infection rate, (infection-related) mortality, time to first febrile episode, need for empirical antibiotic therapy, diet acceptability, and quality of life in adult and paediatric cancer patients receiving chemotherapy causing episodes of neutropenia. DATA COLLECTION AND ANALYSIS: Two review authors independently performed the study selection, 'Risk of bias' assessment and data extraction. Analyses were performed according to the guidelines of the Cochrane Handbook for Systematic Reviews of Interventions. MAIN RESULTS: We identified three RCTs assessing different intervention and control diets in 192 patients (97 randomised to intervention diet; 95 to control diet) with different types of malignancies. Co-interventions (e.g. protective environment, antimicrobial prophylaxis, central venous catheter care, oral care, hygiene practices and colony-stimulating factors) and outcome definitions also differed between studies. In all included studies it was standard policy to give empirical antibiotics (and sometimes also antimycotics) to (some of) the patients diagnosed with an infection. Two studies included adults and one study included children. In all studies only a scant description of treatment regimens was provided. All studies had methodological limitations. Pooling of results of included studies was not possible. In two individual studies no statistically significant difference in infection rate between the intervention and control diet was identified; another study showed no significant difference in the number of chemotherapy cycles with an infection between the treatment groups. None of the studies mentioned infection-related mortality, but in one study no significant difference in overall survival between the treatment groups was observed. Time from onset of neutropenia to fever, the duration of empirical antibiotics and antimycotics, diet acceptability (i.e. following the diet easily and following the diet throughout all chemotherapy cycles) and quality of life were all evaluated by only one study; for all outcomes no statistically significant differences between the treatment arms was observed. AUTHORS' CONCLUSIONS: At the moment there is no evidence from individual RCTs in children and adults with different malignancies that underscores the use of an LBD for the prevention of infection and related outcomes. All studies differed with regard to co-interventions, outcome definitions, and intervention and control diets. Since pooling of results was not possible and all studies had serious methodological limitations, no definitive conclusions can be made. It should be noted that 'no evidence of effect', as identified in this review, is not the same as 'evidence of no effect'. Based on the currently available evidence, we are not able to give recommendations for clinical practice. More high-quality research is needed.

Hepatic late adverse effects after antineoplastic treatment for childhood cancer.

BACKGROUND: Survival rates have greatly improved as a result of more effective treatments for childhood cancer. Unfortunately the improved prognosis has resulted in the occurrence of late, treatment-related complications. Liver complications are common during and soon after treatment for childhood cancer. However, among long-term childhood cancer survivors the risk of hepatic late adverse effects is largely unknown. To make informed decisions about future cancer treatment and follow-up policies it is important to know the risk of, and associated risk factors for, hepatic late adverse effects. OBJECTIVES: To evaluate the existing evidence on the association between antineoplastic treatment for childhood cancer and hepatic late adverse effects. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2009, Issue 2), MEDLINE (1966 to June 2009) and EMBASE (1980 to June 2009). In addition, we searched reference lists of relevant articles and conference proceedings. SELECTION CRITERIA: All studies except case reports, case series and studies including less than 10 patients that examined the association between antineoplastic treatment for childhood cancer (aged 18 years or less at diagnosis) and hepatic late adverse effects (one year or more after the end of treatment). DATA COLLECTION AND ANALYSIS: Two review authors independently performed the study selection, risk of bias assessment and data extraction. MAIN RESULTS: We identified 20 cohort studies investigating hepatic late adverse effects after antineoplastic treatment for childhood cancer. All studies had methodological limitations. The prevalence of hepatic late adverse effects varied widely, between 0% and 84.2%. Selecting studies where the outcome of hepatic late adverse effects was well defined as alanine aminotransferase (ALT) above the upper limit of normal resulted in five studies. In this subgroup the prevalence of hepatic late adverse effects ranged from 8.0% to 52.8%, with follow-up durations varying from one to 27 years after the end of treatment. A more stringent selection process using the outcome definition of ALT as above twice the upper limit of normal resulted in three studies, with a prevalence ranging from 7.9% to 44.8%. Chronic viral hepatitis was identified as a risk factor for hepatic late adverse effects in univariate analyses. It is unclear which specific antineoplastic treatments increase the risk of hepatic late adverse effects AUTHORS' CONCLUSIONS: The prevalence of hepatic late adverse effects ranged from 7.9% to 52.8% when selecting studies with an adequate outcome definition. It has not been established which childhood cancer treatments result in hepatic late adverse effects. There is a suggestion that chronic viral hepatitis increases the risk of hepatic late adverse effects. More well-designed studies are needed to reliably evaluate the prevalence of, and risk factors for, hepatic late adverse effects after antineoplastic treatment for childhood cancer.