scholarly journals Floatation Therapy for Physical Conditions

2022 ◽  
Vol 2 (1) ◽  
Author(s):  
Keeley Farrell ◽  
Hannah Loshak

The clinical effectiveness of floatation therapy for the treatment of physical conditions remains uncertain. One randomized controlled trial was identified that evaluated floatation-restricted environmental stimulation therapy (REST) compared with placebo and waitlist control groups for the treatment of patients with chronic pain. The trial reported no significant differences between the 3 treatment groups on any of the outcomes measured including those related to pain, medication use, quality of life, sleep impairment, anxiety, or depression. One guideline was identified that states that there is insufficient evidence to recommend for or against the use of sensory deprivation tanks in patients with symptoms attributed to mild traumatic brain injury. The cost-effectiveness of floatation therapy for the treatment of physical condition is unknown as no relevant economic evaluations were identified.

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e048141
Author(s):  
Sara Mucherino ◽  
Valentina Lorenzoni ◽  
Valentina Orlando ◽  
Isotta Triulzi ◽  
Marzia Del Re ◽  
...  

IntroductionThe combination of biomarkers and drugs is the subject of growing interest both from regulators, physicians and companies. This study protocol of a systematic review is aimed to describe available literature evidences about the cost-effectiveness, cost-utility or net-monetary benefit of the use of biomarkers in solid tumour as tools for customising immunotherapy to identify what further research needs.Methods and analysisA systematic review of the literature will be carried out according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement guidelines. PubMed and Embase will be queried from June 2010 to June 2021. The PICOS model will be applied: target population (P) will be patients with solid tumours treated with immune checkpoint inhibitors (ICIs); the interventions (I) will be test of the immune checkpoint predictive biomarkers; the comparator (C) will be any other targeted or non-targeted therapy; outcomes (O) evaluated will be health economic and clinical implications assessed in terms of incremental cost-effectiveness ratio, net health benefit, net monetary benefit, life years gained, quality of life, etc; study (S) considered will be economic evaluations reporting cost-effectiveness analysis, cost-utility analysis, net-monetary benefit. The quality of the evidence will be graded according to Grading of Recommendations Assessment, Development and Evaluation.Ethics and disseminationThis systematic review will assess the cost-effectiveness implications of using biomarkers in the immunotherapy with ICIs, which may help to understand whether this approach is widespread in real clinical practice. This research is exempt from ethics approval because the work is carried out on published documents. We will disseminate this protocol in a related peer-reviewed journal.PROSPERO registration numberCRD42020201549.


2018 ◽  
Author(s):  
Patricia Schneider ◽  
Michelle Ghert

Title: Surveillance AFter Extremity Tumor surgerY International Randomized Controlled TrialShort Title: SAFETYMethodology: Multi-center, 2 x 2 factorial superiority randomized controlled trial (RCT).Coordinating Center: This study will be centrally coordinated by the Methods Center at the Center for Evidence-Based Orthopaedics (CEO) at McMaster University in Hamilton, Ontario Canada. Clinical Sites: We are expecting ten clinical sites to be involved in the pilot phase. Further sites will be recruited for the definitive phase.Primary Objectives: The overall objective is to determine the effect of surveillance strategy on patient survival after surgery for a soft-tissue sarcoma of the extremity by comparing the effectiveness of: A) a surveillance frequency of every three months vs. every six months; and B) CT scans vs. chest radiographs.Secondary Objectives: We will explore: A) the effects of the post-operative surveillance strategies on patient-important outcomes (patient anxiety, overall satisfaction and quality of life), oncologic outcomes (local recurrence- and metastasis-free survival) and treatment-related complications (chemotherapy- and thoracotomy-related complications); and B) the net costs of post-operative surveillance strategies and of metastasis treatment and treatment-related complications. Treatment Groups: This study will compare two surveillance frequencies (every three months vs. every six months) and two imaging modalities (CT scan vs. chest radiograph) for a total of four treatment groups: 1)Surveillance visit and chest CT scan every three months for two years;2)Surveillance visit and chest CT scan every six months for two years; 3)Surveillance visit and chest radiograph every three months for two years; or4)Surveillance visit and chest radiograph every six months for two years. Study Outcome: The primary outcome is overall survival at five years post-randomization. Follow-Up: Upon completion of the two-year intervention phase, study participants will be followed every six months for another three years. Sample Size: Pilot - 200 participants | Definitive - 830 participantsEstimated Study Duration: Pilot - September 2019 – January 2023 | Definitive - TBDSignificance: Following treatment for a primary extremity sarcoma, patients remain at risk for the development of local and systemic disease recurrence. Metastasis (distant recurrence) to the lung is the most frequent single location of disease recurrence in sarcoma patients, occurring in almost half of all patients. Therefore, careful post-operative surveillance is an integral element of patient care. However, the detection of metastases does not necessarily affect long-term survival and may negatively impact quality of life. Surveillance strategies have not been well researched and have been identified as the top research priority in the extremity sarcoma field. The SAFETY trial will provide the necessary evidence to develop evidence-based surveillance guidelines, and is poised to have a significant impact on the post-operative care and outcomes of extremity soft-tissue sarcoma patients.


2020 ◽  
Vol 24 (2) ◽  
pp. 1-180 ◽  
Author(s):  
Nigel Fleeman ◽  
Rachel Houten ◽  
Adrian Bagust ◽  
Marty Richardson ◽  
Sophie Beale ◽  
...  

Background Thyroid cancer is a rare cancer, accounting for only 1% of all malignancies in England and Wales. Differentiated thyroid cancer (DTC) accounts for ≈94% of all thyroid cancers. Patients with DTC often require treatment with radioactive iodine. Treatment for DTC that is refractory to radioactive iodine [radioactive iodine-refractory DTC (RR-DTC)] is often limited to best supportive care (BSC). Objectives We aimed to assess the clinical effectiveness and cost-effectiveness of lenvatinib (Lenvima®; Eisai Ltd, Hertfordshire, UK) and sorafenib (Nexar®; Bayer HealthCare, Leverkusen, Germany) for the treatment of patients with RR-DTC. Data sources EMBASE, MEDLINE, PubMed, The Cochrane Library and EconLit were searched (date range 1999 to 10 January 2017; searched on 10 January 2017). The bibliographies of retrieved citations were also examined. Review methods We searched for randomised controlled trials (RCTs), systematic reviews, prospective observational studies and economic evaluations of lenvatinib or sorafenib. In the absence of relevant economic evaluations, we constructed a de novo economic model to compare the cost-effectiveness of lenvatinib and sorafenib with that of BSC. Results Two RCTs were identified: SELECT (Study of [E7080] LEnvatinib in 131I-refractory differentiated Cancer of the Thyroid) and DECISION (StuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine-refractory thyrOid caNcer). Lenvatinib and sorafenib were both reported to improve median progression-free survival (PFS) compared with placebo: 18.3 months (lenvatinib) vs. 3.6 months (placebo) and 10.8 months (sorafenib) vs. 5.8 months (placebo). Patient crossover was high (≥ 75%) in both trials, confounding estimates of overall survival (OS). Using OS data adjusted for crossover, trial authors reported a statistically significant improvement in OS for patients treated with lenvatinib compared with those given placebo (SELECT) but not for patients treated with sorafenib compared with those given placebo (DECISION). Both lenvatinib and sorafenib increased the incidence of adverse events (AEs), and dose reductions were required (for > 60% of patients). The results from nine prospective observational studies and 13 systematic reviews of lenvatinib or sorafenib were broadly comparable to those from the RCTs. Health-related quality-of-life (HRQoL) data were collected only in DECISION. We considered the feasibility of comparing lenvatinib with sorafenib via an indirect comparison but concluded that this would not be appropriate because of differences in trial and participant characteristics, risk profiles of the participants in the placebo arms and because the proportional hazard assumption was violated for five of the six survival outcomes available from the trials. In the base-case economic analysis, using list prices only, the cost-effectiveness comparison of lenvatinib versus BSC yields an incremental cost-effectiveness ratio (ICER) per quality-adjusted life-year (QALY) gained of £65,872, and the comparison of sorafenib versus BSC yields an ICER of £85,644 per QALY gained. The deterministic sensitivity analyses show that none of the variations lowered the base-case ICERs to < £50,000 per QALY gained. Limitations We consider that it is not possible to compare the clinical effectiveness or cost-effectiveness of lenvatinib and sorafenib. Conclusions Compared with placebo/BSC, treatment with lenvatinib or sorafenib results in an improvement in PFS, objective tumour response rate and possibly OS, but dose modifications were required to treat AEs. Both treatments exhibit estimated ICERs of > £50,000 per QALY gained. Further research should include examination of the effects of lenvatinib, sorafenib and BSC (including HRQoL) for both symptomatic and asymptomatic patients, and the positioning of treatments in the treatment pathway. Study registration This study is registered as PROSPERO CRD42017055516. Funding The National Institute for Health Research Health Technology Assessment programme.


1999 ◽  
Vol 68 (1) ◽  
pp. 163-171 ◽  
Author(s):  
J. G. Jago ◽  
L. R. Matthews ◽  
T. E. Trigg ◽  
P. Dobbie ◽  
J. J. Bass

AbstractActive immunization against gonadotropin-releasing hormone (GnRH), commonly known as immunocastration, has been proposed as an alternative to traditional methods of castrating bulls. This study evaluated the effects of immunocastration on growth, behaviour and meat quality of post-pubertal bulls. Bulls were either vaccinated against GnRH (no. = 30, I) or left intact (no. = 30, B). A third treatment consisted of steers (no. = 20, S) that had been castrated pre-pubertally. The animals were run in eight single treatment groups (no. = 10 per group), three of each of В and I and two groups of S. Anti-GnRH antibodies developed and plasma testosterone concentrations declined in I following immunization. Aggressive behaviour of I declined to be lower (P < 0·5) than B and no different from S, 5 weeks after primary immunization. Seven weeks after immunocastration all animals were slaughtered. The hot carcass weight of I was between that of B and S but not significantly different from either. There were no effects of treatment on pHu or meat colour measurements. Taste panel assessment rated I higher than B, but lower than S for tenderness, juiciness and overall palatability. These results demonstrate that immunocastration of post-pubertal bulls 7 weeks before slaughter is a potential means of reducing problematic bull behaviour and improving meat quality although this is likely to be at the cost of reduced weight gain.


2012 ◽  
Vol 27 (2) ◽  
pp. 133-141 ◽  
Author(s):  
Venkatesan Prem ◽  
Ramesh Chandra Sahoo ◽  
Prabha Adhikari

Objective: To compare two breathing exercises (Buteyko and pranayama) with a control group in patients with asthma. Design: Randomized controlled trial. Subjects: One hundred and twenty subjects were randomized to three groups through block randomization. Subjects with an Asthma Quality of Life Questionnaire score <5.5 participated in the study. Setting: Outpatient pulmonary medicine department. Interventions: Subjects in the Buteyko and pranayama groups were trained for 3–5 days and instructed to practise the exercises for 15 minutes twice daily, and for three months duration. The control group underwent routine pharmacological management during the study period. Outcome measures: Asthma Quality of Life Questionnaire, Asthma Control Questionnaire and pulmonary function test. Results: The baseline characteristics were similar in all three groups. Post intervention, the Buteyko group showed better trends of improvement (mean (95% confidence interval), P-value) in total Asthma Quality of Life Questionnaire score than the pranayama (0.47 (–0.008–0.95), P = 0.056) and control groups (0.97 (0.48–1.46), P = 0.0001). In comparison between the pranayama and control groups, pranayama showed significant improvement (0.50 (0.01–0.98), P = 0.042) in total Asthma Quality of Life Questionnaire score. Conclusion: The Buteyko group showed better trends of improvement in quality of life and asthma control than the group performing the pranayama breathing exercise.


2009 ◽  
Vol 25 (03) ◽  
pp. 339-349 ◽  
Author(s):  
Julie Polisena ◽  
Doug Coyle ◽  
Kathryn Coyle ◽  
Sarah McGill

Objectives:The research objectives were two-fold: first, to systematically review the literature on the cost-effectiveness of home telehealth for chronic diseases, and second to develop a framework for the conduct of economic evaluation of home telehealth projects for patients with chronic diseases.Methods:A comprehensive literature search identified twenty-two studies (n= 4,871 patients) on home telehealth for chronic diseases published between 1998 and 2008. Studies were reviewed in terms of their methodological quality and their conclusions.Results:Home telehealth was found to be cost saving from the healthcare system and insurance provider perspectives in all but two studies, but the quality of the studies was generally low. An evaluative framework was developed which provides a basis to improve the quality of future studies to facilitate improved healthcare decision making, and an application of the framework is illustrated using data from an existing program evaluation of a home telehealth program.Conclusions:Current evidence suggests that home telehealth has the potential to reduce costs, but its impact from a societal perspective remains uncertain until higher quality studies become available.


2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Francois van Loggerenberg ◽  
Michael McGrath ◽  
Dickens Akena ◽  
Harriet Birabwa-Oketcho ◽  
Camilo Andrés Cabarique Méndez ◽  
...  

Abstract Background DIALOG+ is a resource-oriented and evidence-based intervention to improve quality of life and reduce mental distress. While it has been extensively studied in mental health care, there is little evidence for how to use it in primary care settings for patients with chronic physical conditions. Considering that DIALOG+ is used in existing routine patient-clinician meetings and is very low cost, it may have the potential to help large numbers of patients with chronic physical conditions, mental distress and poor quality of life who are treated in primary care. This is particularly relevant in low- and middle-income countries (LMICs) where resources for specialised services for such patients are scarce or non-existent. Methods An exploratory non-controlled trial will be conducted to primarily assess the feasibility and acceptability and, secondarily, outcomes of delivering DIALOG+ to patients with chronic physical conditions and poor quality of life in primary care settings in Bosnia and Herzegovina, Colombia and Uganda. Thirty patients in each country will receive DIALOG+ up to three times in monthly meetings over a 3-month period. Feasibility will be assessed by determining the extent to which the intervention is implemented as planned. Experiences will be captured in interviews and focus groups with care providers and participants to understand acceptability. Quality of life, symptoms of anxiety and depression, objective social situation and health status will be assessed at baseline and again after the three-session intervention. Discussion This study will inform our understanding of the extent to which DIALOG+ may be used in the routine care of patients with chronic physical conditions in different primary care settings. The findings of this exploratory trial can inform the design of future full randomised controlled trials of DIALOG+ in primary care settings in LMICs. Trial registration All studies were registered prospectively (on 02/12/2020 for Uganda and Bosnia and Herzegovina, and 01/12/2020 for Colombia) within the ISRCTN Registry. ISRCTN17003451 (Bosnia and Herzegovina), ISRCTN14018729 (Colombia) and ISRCTN50335796 (Uganda). Protocol version and date: v2.0; 28/07/2020 (Bosnia and Herzegovina), v0.3 02/08/2020 (Colombia) and v1.0, 05/11/2020 (Uganda).


2006 ◽  
Vol 188 (4) ◽  
pp. 323-329 ◽  
Author(s):  
Leona Hakkaart-Van Roijen ◽  
Annemieke Van Straten ◽  
Maiwenn Al ◽  
Frans Rutten ◽  
Marianne Donker

BackgroundThe cost-utility of brief therapy compared with cognitive–behavioural therapy (CBT) and care as usual in the treatment of depression and anxiety has not yet been determined.AimsTo assess the cost-utility of brief therapy compared with CBT and care as usual.MethodA pragmatic randomised controlled trial involving 702 patients was conducted at 7 Dutch mental healthcare centres (MHCs). Patients were interviewed at baseline and then every 3 months over a period of 1.5 years, during which time data were collected on direct costs, indirect costs and quality of life.ResultsThe mean direct costs of treatment at the MHCs were significantly lower for brief therapy than for CBT and care as usual. However, after factoring in other healthcare costs and indirect costs, no significant differences between the treatment groups could be detected. We found no significant differences in quality-adjusted life-years between the groups.ConclusionsCost-utility did not differ significantly between the three treatment groups.


2011 ◽  
Vol 24 (1) ◽  
pp. 6-18 ◽  
Author(s):  
Carys Jones ◽  
Rhiannon Tudor Edwards ◽  
Barry Hounsome

ABSTRACTBackground: Dementia places a huge demand on healthcare services; however, a large proportion of the cost is borne by informal caregivers. With the number of people affected by dementia set to increase in the future, there is a need for research to consider the effects of interventions on informal caregivers as well as on the individuals with dementia. This paper seeks to systematically review the existing evidence on the cost-effectiveness of interventions to support informal caregivers of people with dementia residing in the community.Methods: A range of electronic databases was searched. Studies were included if both costs and outcome measures for informal caregivers of people with dementia residing in the community were reported for an intervention. Both pharmacological and non-pharmacological interventions were included. Quality of study was assessed using the Drummond ten-item checklist for economic evaluations and results were presented through narrative synthesis.Results: Twelve studies were included in the review; of these only four reported a significant difference in the outcome measure for caregivers.Conclusions: At present few published studies report costs in enough detail to provide evidence of the effectiveness and cost-effectiveness of interventions for supporting caregivers. Future trials need to collect caregiver data alongside patient data in order to increase the evidence base for intervention effectiveness. Further research is required to establish the effectiveness and cost-effectiveness of both pharmacological and non-pharmacological approaches.


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