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  1. Article ; Online: Natural ghrelin in advanced cancer patients with cachexia, a case series.

    Blum, David / de Wolf-Linder, Susanne / Oberholzer, Rolf / Brändle, Michael / Hundsberger, Thomas / Strasser, Florian

    Journal of cachexia, sarcopenia and muscle

    2021  Volume 12, Issue 2, Page(s) 506–516

    Abstract: Background: Natural ghrelin, a peptide growth hormone secretagogue, has a therapeutic potential in cachexia. We designed a dose-finding trial of subcutaneous natural ghrelin to improve nutritional intake (NI) in advanced cancer patients.: Methods: ... ...

    Abstract Background: Natural ghrelin, a peptide growth hormone secretagogue, has a therapeutic potential in cachexia. We designed a dose-finding trial of subcutaneous natural ghrelin to improve nutritional intake (NI) in advanced cancer patients.
    Methods: Advanced cancer patients with cachexia management (symptom management, physiotherapy, nutritional, and psychosocial support) started with ghrelin at 32 μg/kg body weight, followed by 50% dose increases. Patients self-injected ghrelin twice daily for 4 days followed by a wash-out period. After reaching the primary endpoint, maximal NI (minimal dose for maximal NI), a maintenance period followed during which patients injected 10 doses of ghrelin per week. Safety parameters, NI, and cachexia outcomes (symptoms, narratives, muscle mass, and strength) were measured over 6 weeks.
    Results: Ten patients with metastatic solid tumours were included, and six (100% male, mean age 61.8 ± 8.5 SD) received ghrelin. Minimal dose for maximal NI was reached in four patients. Three patients reached the end-of study visit. Ghrelin was well tolerated with variable results on appetite and eating-related symptoms but a positive effect in the narratives. Mean Functional Assessment of Appetite & Cachexia Therapy score was 6.8 points lower at final measurement compared with baseline, t(5) = 5.98, P < .01. Muscle mass was stable in two patients and increased in one patient, and muscle strength was stable in three patients. Subjective tolerability was high. Patients showed a fluctuating trajectory, and median survival was 88 days (51-412 days).
    Conclusions: Ghrelin was safe in advanced patients with cancer cachexia without dose-limiting toxicity and well tolerated. The intervention was very complex, and the number of patients included was small. There was a positive effect on nutritional intake and patient narratives.
    MeSH term(s) Aged ; Appetite ; Cachexia/drug therapy ; Cachexia/etiology ; Eating ; Ghrelin ; Humans ; Male ; Middle Aged ; Neoplasms/complications
    Chemical Substances Ghrelin
    Language English
    Publishing date 2021-01-15
    Publishing country Germany
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2586864-0
    ISSN 2190-6009 ; 2190-5991
    ISSN (online) 2190-6009
    ISSN 2190-5991
    DOI 10.1002/jcsm.12659
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Computer-Based Clinical Decision Support Systems and Patient-Reported Outcomes: A Systematic Review.

    Blum, David / Raj, Sunil X / Oberholzer, Rolf / Riphagen, Ingrid I / Strasser, Florian / Kaasa, Stein

    The patient

    2015  Volume 8, Issue 5, Page(s) 397–409

    Abstract: Background: Evidence-based treatment guidelines embedded in computer-based clinical decision support systems (CCDSS) may improve patient-reported outcomes (PRO). We systematically reviewed the literature for content and application of CCDSS, and their ... ...

    Abstract Background: Evidence-based treatment guidelines embedded in computer-based clinical decision support systems (CCDSS) may improve patient-reported outcomes (PRO). We systematically reviewed the literature for content and application of CCDSS, and their effects on PRO.
    Methods: A systematic review in MEDLINE and EMBASE was conducted according to PRISMA standards. Searches were limited to the publication period 1996-May 2014 and the English language. The search terms covered "computerized clinical decision systems" and "patient-reported outcomes". Screening and extraction was done independently by two reviewers according to predefined inclusion (computer and guideline) and exclusion criteria (no trial, no PRO). Study and CCDSS quality was rated according to predefined criteria.
    Results: The database searches identified 1,331 references. Eighty-seven full-text articles were analyzed. The main reason for exclusion was no PRO as a study outcome measure. Fifteen studies met the inclusion criteria, representing 13,480 patients. Nine studies used a computerized device to fill in data; in four studies, this was used by the patients themselves. Most of the studies presented the data to the clinician at point of care and incorporated international guidelines. Three studies showed a positive effect on PRO, but only on symptoms. Overall, no negative effects were reported. There was no association with study quality or year of study publication.
    Conclusion: There are marginal positive effects of CCDSS on specific PRO. Factors that facilitate the use and effect are identified. Easy to use systems with difficult to ignore evidence-based advice need to be developed and tested.
    MeSH term(s) Databases, Bibliographic ; Decision Support Systems, Clinical ; Evidence-Based Practice ; Humans ; Patient Outcome Assessment
    Language English
    Publishing date 2015-10
    Publishing country New Zealand
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Review
    ZDB-ID 2466680-4
    ISSN 1178-1661 ; 1178-1653
    ISSN (online) 1178-1661
    ISSN 1178-1653
    DOI 10.1007/s40271-014-0100-1
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Psychosocial effects of cancer cachexia: a systematic literature search and qualitative analysis.

    Oberholzer, Rolf / Hopkinson, Jane B / Baumann, Kim / Omlin, Aurelius / Kaasa, Stein / Fearon, Kenneth C / Strasser, Florian

    Journal of pain and symptom management

    2013  Volume 46, Issue 1, Page(s) 77–95

    Abstract: Context: Cancer cachexia is debilitating and affects most patients with advanced cancer. Because treatment options are poor, the psychosocial effects of cancer cachexia always should be assessed and psychosocial support provided.: Objectives: To ... ...

    Abstract Context: Cancer cachexia is debilitating and affects most patients with advanced cancer. Because treatment options are poor, the psychosocial effects of cancer cachexia always should be assessed and psychosocial support provided.
    Objectives: To review the existing evidence of psychosocial effects of cancer cachexia with the aim of identifying factors that might be modified to improve outcomes.
    Methods: We carried out a systematic literature search in MEDLINE and Embase. The search string included key words for the topics "advanced cancer," "cancer cachexia," and "psychosocial effects." Publications were selected by two reviewers. The search was complemented by a hand search.
    Results: Nineteen studies were included. The available information revealed mechanisms leading to, various presentations of, and coping strategies for psychosocial effects of cancer cachexia in both patients and their carers. Not all those affected manage the effects of the condition constructively. A number of clinically important adverse reactions have been identified. The main causes for negative psychosocial effects are a lack of knowledge of the irreversible nature of cancer cachexia and unsuccessful attempts to increase body weight with altered patterns of nutritional intake. Depending on patients' and their carers' coping resources, psychosocial effects may escalate or decrease. Early identification of psychosocial effects creates the potential for psychosocial interventions that improve the quality of life of those affected. Our analysis engendered a broader conceptualization of the psychosocial effects of cancer cachexia, leading to a number of suggestions for psychosocial interventions with the potential for providing relief.
    Conclusion: The concept of psychosocial effects in cancer cachexia has the potential to sensitize health care professionals to cachexia-related problems and inform their clinical management of the condition.
    MeSH term(s) Adaptation, Psychological ; Body Weight ; Cachexia/etiology ; Cachexia/psychology ; Humans ; Neoplasms/complications ; Neoplasms/psychology ; Quality of Life/psychology
    Language English
    Publishing date 2013-07
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Review
    ZDB-ID 639142-4
    ISSN 1873-6513 ; 0885-3924
    ISSN (online) 1873-6513
    ISSN 0885-3924
    DOI 10.1016/j.jpainsymman.2012.06.020
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Psychosocial consequences of cancer cachexia: the development of an item bank.

    Häne, Hanspeter / Oberholzer, Rolf / Walker, Jochen / Hopkinson, Jane B / de Wolf-Linder, Susanne / Strasser, Florian

    Journal of pain and symptom management

    2013  Volume 46, Issue 6, Page(s) 795–806

    Abstract: Context: Cancer cachexia syndrome (CCS) is often accompanied by psychosocial consequences (PSC). To alleviate PSC, a systematic assessment method is required. Currently, few assessment tools are available (e.g., Functional Assessment of Anorexia/ ... ...

    Abstract Context: Cancer cachexia syndrome (CCS) is often accompanied by psychosocial consequences (PSC). To alleviate PSC, a systematic assessment method is required. Currently, few assessment tools are available (e.g., Functional Assessment of Anorexia/Cachexia Therapy). There is no systematic assessment tool that captures the PSC of CCS.
    Objectives: To develop a pilot item bank to assess the PSC of CCS.
    Methods: A total of 132 questions, generated from patient answers in a previous study, were reduced to 121 items by content analysis and evaluation by multidisciplinary experts (doctor, nutritionists, and nurses). In our two-step, cross-sectional study, patients, judged by staff to have PSC of CCS, were included, and the questions were randomly allocated to the patients. Questions were evaluated for understandability and triggering emotions, and patients were asked to provide a response using a four-point Likert scale. Subsequently, problematic questions were revised, reformulated, and retested.
    Results: A total of 20 patients with a variety of tumor types participated. Of the 121 questions, 31 had to be reformulated after Step 1 and were retested in Step 2, after which seven were again evaluated as not being perfectly comprehensible. In Step 1, 22 questions were found to trigger emotions, but no item required remodeling. Item performance using the Likert scale revealed no consistent floor or ceiling effects. Our final pilot question bank comprised 117 questions.
    Conclusion: The final item bank contains questions that are understood and accepted by the patients. This item bank now needs to be developed into a measurement tool that groups items into domains and can be used in future research studies.
    MeSH term(s) Aged ; Cachexia/diagnosis ; Cachexia/etiology ; Cachexia/psychology ; Cross-Sectional Studies ; Female ; Humans ; Male ; Middle Aged ; Neoplasms/complications ; Neoplasms/diagnosis ; Neoplasms/psychology ; Psychology ; Psychometrics/methods ; Quality of Life ; Reproducibility of Results ; Sensitivity and Specificity ; Severity of Illness Index ; Surveys and Questionnaires
    Language English
    Publishing date 2013-12
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 639142-4
    ISSN 1873-6513 ; 0885-3924
    ISSN (online) 1873-6513
    ISSN 0885-3924
    DOI 10.1016/j.jpainsymman.2013.01.008
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Safety and immunogenicity of RTS,S/AS02D malaria vaccine in infants.

    Abdulla, Salim / Oberholzer, Rolf / Juma, Omar / Kubhoja, Sulende / Machera, Francisca / Membi, Christopher / Omari, Said / Urassa, Alwisa / Mshinda, Hassan / Jumanne, Ajuza / Salim, Nahya / Shomari, Mwanjaa / Aebi, Thomas / Schellenberg, David M / Carter, Terrell / Villafana, Tonya / Demoitié, Marie-Ange / Dubois, Marie-Claude / Leach, Amanda /
    Lievens, Marc / Vekemans, Johan / Cohen, Joe / Ballou, W Ripley / Tanner, Marcel

    The New England journal of medicine

    2008  Volume 359, Issue 24, Page(s) 2533–2544

    Abstract: Background: The RTS,S/AS malaria vaccine is being developed for delivery through the World Health Organization's Expanded Program on Immunization (EPI). We assessed the feasibility of integrating RTS,S/AS02D into a standard EPI schedule for infants.: ... ...

    Abstract Background: The RTS,S/AS malaria vaccine is being developed for delivery through the World Health Organization's Expanded Program on Immunization (EPI). We assessed the feasibility of integrating RTS,S/AS02D into a standard EPI schedule for infants.
    Methods: In this phase 2B, single-center, double-blind, controlled trial involving 340 infants in Bagamoyo, Tanzania, we randomly assigned 340 infants to receive three doses of either the RTS,S/AS02D vaccine or the hepatitis B vaccine at 8, 12, and 16 weeks of age. All infants also received a vaccine containing diphtheria and tetanus toxoids, whole-cell pertussis vaccine, and conjugated Haemophilus influenzae type b vaccine (DTPw/Hib). The primary objectives were the occurrence of serious adverse events during a 9-month surveillance period and a demonstration of noninferiority of the responses to the EPI vaccines (DTPw/Hib and hepatitis B surface antigen) with coadministration of the RTS,S/AS02D vaccine, as compared with the hepatitis B vaccine. The detection of antibodies against Plasmodium falciparum circumsporozoite and efficacy against malaria infection were secondary objectives.
    Results: At least one serious adverse event was reported in 31 of 170 infants who received the RTS,S/AS02D vaccine (18.2%; 95% confidence interval [CI], 12.7 to 24.9) and in 42 of 170 infants who received the hepatitis B vaccine (24.7%; 95% CI, 18.4 to 31.9). The results showed the noninferiority of the RTS,S/AS02D vaccine in terms of antibody responses to EPI antigens. One month after vaccination, 98.6% of infants receiving the RTS,S/AS02D vaccine had seropositive titers for anticircumsporozoite antibodies on enzyme-linked immunosorbent assay (ELISA). During the 6-month period after the third dose of vaccine, the efficacy of the RTS,S/AS02D vaccine against first infection with P. falciparum malaria was 65.2% (95% CI, 20.7 to 84.7; P=0.01).
    Conclusions: The use of the RTS,S/AS02D vaccine in infants had a promising safety profile, did not interfere with the immunologic responses to coadministered EPI antigens, and reduced the incidence of malaria infection. (ClinicalTrials.gov number, NCT00289185.)
    MeSH term(s) Animals ; Antibodies, Protozoan/blood ; Bacterial Vaccines ; Double-Blind Method ; Female ; Hepatitis B Surface Antigens/immunology ; Humans ; Infant ; Kaplan-Meier Estimate ; Malaria Vaccines/administration & dosage ; Malaria Vaccines/adverse effects ; Malaria Vaccines/immunology ; Malaria, Falciparum/epidemiology ; Malaria, Falciparum/immunology ; Malaria, Falciparum/prevention & control ; Male ; Plasmodium falciparum/immunology ; Protozoan Proteins/immunology
    Chemical Substances Antibodies, Protozoan ; Bacterial Vaccines ; Hepatitis B Surface Antigens ; Malaria Vaccines ; Protozoan Proteins ; RTS,S-AS02D vaccine ; circumsporozoite protein, Protozoan
    Language English
    Publishing date 2008-12-11
    Publishing country United States
    Document type Clinical Trial, Phase II ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMoa0807773
    Database MEDical Literature Analysis and Retrieval System OnLINE

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