scholarly journals Acupuncture for cancer pain: protocol for a pilot pragmatic randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e025564
Author(s):  
Yihan He ◽  
Brian H May ◽  
Anthony Lin Zhang ◽  
Xinfeng Guo ◽  
Yihong Liu ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Cancer Pain ◽  
Clinical Guidelines ◽  
Controlled Trial ◽  
Ethics Committee ◽  
Control Group ◽  
Clinical Effects ◽  
Phone Calls ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

IntroductionAlthough acupuncture has been recommended for alleviating cancer pain by clinical guidelines, the level of the supporting evidence needs to be improved. A pragmatic randomised controlled trial (pRCT) in a hospital setting would provide real-world assessments of the overall clinical effects of acupuncture. This pilot trial aims to explore the feasibility and provide data for sample size calculations for a pRCT evaluating the effectiveness of acupuncture as an adjunctive therapy to routine medical care for cancer pain.Methods and analysisThirty patients with cancer admitted to the oncology department with moderate or severe pain will be recruited. Participants will be randomised at a ratio of 1:1 to the adjunctive acupuncture group or a control group which receives routine pain management without acupuncture. The standardised section of the acupuncture protocol will be developed based on the results of reviews of the literature, recommendations in clinical guidelines and interviews with clinical experts. The acupuncturist will be allowed to tailor the protocol according to the individual situation of each participant. Primary outcomes relevant to the feasibility of conducting a fully powered trial include: numbers and proportions of participants recruited, screened, consented and randomised; numbers and reasons for withdrawals and dropouts; numbers and types of adverse events; feasibility of implementing the trial procedures; evaluation of the comprehensiveness and ease-of-use of the case report form. Secondary outcomes are clinical measurements of the effectiveness of the treatment that are intended for use in the full-scale trial. Analysis of feasibility will be descriptive and pain intensity measures will be analysed using mixed-effects regression.Ethics and disseminationEthics approval was obtained from the Institutional Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine (approval no: Z2017-184-01) and RMIT University Human Research Ethics Committee (reference no: 21361). Results will be disseminated in a peer-reviewed journal, and trial participants will be informed via email and/or phone calls.Trial registration numberChiCTR1800017023

scholarly journals Psychiatric hospital reform in low-income and middle-income countries Structured Individualised inTervention And Recovery (SITAR): a two-arm pragmatic randomised controlled trial study protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e035753
Author(s):  
Tasneem Raja ◽  
Helena Tuomainen ◽  
Jason Madan ◽  
Dipesh Mistry ◽  
Sanjeev Jain ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Psychiatric Hospital ◽  
Patient Outcomes ◽  
Low Income ◽  
Controlled Trial ◽  
Ethics Committee ◽  
Middle Income ◽  
Hospital Reform ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

IntroductionLow-income and middle-income settings like India have large treatment gaps in mental healthcare. People with severe mental disorders face impediments to their clinical and functional recovery, and have large unmet needs. The infrastructure and standards of care are poor in colonial period psychiatric hospitals, with no clear pathways to discharge and successfully integrate recovered individuals into the community. Our aim is to study the impact of psychiatric hospital reform on individual patient outcomes in a psychiatric hospital in India.Methods and analysisStructured Individualised inTervention And Recovery (SITAR) is a two-arm pragmatic randomised controlled trial, focusing on patients aged 18–60 years with a hospital stay of 12–120 months and a primary diagnosis of psychosis. It tests the effectiveness of structural and process reform with and without an individually tailored recovery plan on patient outcomes of disability (primary outcome WHO Disability Assessment Scale), symptom severity, social and occupational functioning and quality of life. A computer-generated permuted block randomisation schedule will allocate recruited subjects to the two study arms. We aim to recruit 100 people into each trial arm. Baseline and outcome measures will be undertaken by trained researchers independent to the case managers providing the individual intervention. A health economic analysis will determine the costing of implementing the individually tailored recovery plan.Ethics and disseminationThe study will provide answers to important questions around the nature and process of reforms in institutional care that promote recovery while being cognizant of protecting human rights, and dignity. Ethical approval for SITAR was obtained from a registered ethics committee in India (Institutional Ethics Committee VikasAnvesh Foundation, VAF/2018-19/012 dated 6 December 2018) and the University of Warwick’s Biomedical and Scientific Research Ethics Committee (REGO-2019–2332, dated 21 March 2019), and registered on the Central Trial Registry of India (CTRI/2019/01/017267). Trial results will be published in accordance to CONSORT guidelines.

Longer-Term Clinical and Economic Benefits of Offering Acupuncture to Patients with Chronic Low Back Pain Assessed as Suitable for Primary Care Management – 3 Month Clinical Outcomes from a Controlled Trial of 241 Patients

2002 ◽  
Vol 20 (2-3) ◽  
pp. 121-137
Author(s):  
H Macpherson ◽  
K Thomas ◽  
J Brazier ◽  
M Fitter ◽  
L Thorpe ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Randomised Controlled Trial ◽  
Clinical Outcomes ◽  
Controlled Trial ◽  
Bodily Pain ◽  
Control Group ◽  
Low Back ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

Objectives To undertake a pragmatic randomised controlled trial to test the hypothesis that a population of patients with persistent low back pain, when given access to an acupuncture service, gain more relief from pain than those offered usual management only, for equal or less cost. Methods The study is a pragmatic randomised controlled trial (n=241). Suitable patients are identified by their general practitioners. Patients randomised to the experimental arm are offered the option of referral for up to 10 individualised treatments from one of six qualified acupuncture practitioners. The control group continues to receive usual management from their general practitioner. The primary scale used for measuring change is the Bodily Pain (SF–36) at 3 months and 12 months post randomisation. The main outcome is cost-effectiveness at 12 months. Results A total of 43 general practitioners participated in the trial and 241 patients were randomised. All patients randomised to the option of acupuncture chose to receive treatment. Clinical outcomes at 3 months show that the SF-36 Bodily Pain scores improved by 29.4 and 24.9 points in the acupuncture and normal management group respectively (p=0.125). Patients in the acupuncture group reported lower levels of worry at three months (p<0.001). Conclusions It is possible to conduct a large pragmatic randomised controlled trial of acupuncture in a primary care setting. Acupuncture is seen as an acceptable treatment by patients with low back pain. Clinical outcomes at three months suggest that the acupuncture group are in less pain than the control group.

scholarly journals A protocol for a multicentre, parallel-group, pragmatic randomised controlled trial to evaluate the NEVERMIND system in preventing and treating depression in patients with severe somatic conditions

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Vladimir Carli ◽  
Danuta Wasserman ◽  
Gergö Hadlaczky ◽  
Nuhamin Gebrewold Petros ◽  
Sara Carletto ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Physiological Data ◽  
Control Group ◽  
Evidence Based ◽  
Treatment As Usual ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

Abstract Background Depressive symptoms are common in individuals suffering from severe somatic conditions. There is a lack of interventions and evidence-based interventions aiming to reduce depressive symptoms in patients with severe somatic conditions. The aim of the NEVERMIND project is to address these issues and provide evidence by testing the NEVERMIND system, designed to reduce and prevent depressive symptoms in comparison to treatment as usual. Methods The NEVERMIND study is a parallel-groups, pragmatic randomised controlled trial to assess the effectiveness of the NEVERMIND system in reducing depressive symptoms among individuals with severe somatic conditions. The NEVERMIND system comprises a smart shirt and a user interface, in the form of a mobile application. The system is a real-time decision support system, aiming to predict the severity and onset of depressive symptoms by modelling the well-being condition of patients based on physiological data, body movement, and the recurrence of social interactions. The study includes 330 patients who have a diagnosis of myocardial infarction, breast cancer, prostate cancer, kidney failure, or lower limb amputation. Participants are randomised in blocks of ten to either the NEVERMIND intervention or treatment as usual as the control group. Clinical interviews and structured questionnaires are administered at baseline, at 12 weeks, and 24 weeks to assess whether the NEVERMIND system is superior to treatment as usual. The endpoint of primary interest is Beck Depression Inventory II (BDI-II) at 12 weeks defined as (i) the severity of depressive symptoms as measured by the BDI-II. Secondary outcomes include prevention of the onset of depressive symptoms, changes in quality of life, perceived stigma, and self-efficacy. Discussion There is a lack of evidence-based interventions aiming to reduce and prevent depressive symptoms in patients with severe somatic conditions. If the NEVERMIND system is effective, it will provide healthcare systems with a novel and innovative method to attend to depressive symptoms in patients with severe somatic conditions. Trial registration DRKS00013391. Registered 23 November 2017.

scholarly journals Simplified 0+1 and 1+1 pneumococcal vaccine schedules in Ho Chi Minh City, Vietnam: protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e056505
Author(s):  
Beth Temple ◽  
Hau Phuc Tran ◽  
Vo Thi Trang Dai ◽  
Kathryn Bright ◽  
Doan Y Uyen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Ethics Committee ◽  
Antibody Responses ◽  
Ho Chi Minh City ◽  
Control Group ◽  
Reduced Dose ◽  
Open Access Journals ◽  
Vaccine Type ◽  
Randomised Controlled

IntroductionReduced-dose schedules offer a more efficient and affordable way to use pneumococcal conjugate vaccines (PCVs). Such schedules rely primarily on the maintenance of herd protection. The Vietnam Pneumococcal Trial II (VPT-II) will evaluate reduced-dose schedules of PCV10 and PCV13 utilising an unvaccinated control group. Schedules will be compared in relation to their effect on nasopharyngeal carriage and immunogenicity.Methods and analysisVPT-II is a single-blind open-label randomised controlled trial of 2500 infants in three districts of Ho Chi Minh City, Vietnam. Eligible infants have no clinically significant maternal or perinatal history and are born at or after 36 weeks’ gestation. Participants are recruited at 2 months of age and randomly assigned (4:4:4:4:9) using block randomisation, stratified by district, to one of five groups: four intervention groups that receive PCV10 in a 0+1 (at 12 months) or 1+1 (at 2 and 12 months) schedule or PCV13 in the same 0+1 or 1+1 schedule; and a control group (that receives a single dose of PCV10 at 24 months). Participants are followed up to 24 months of age. The primary outcome is vaccine-type pneumococcal carriage at 24 months of age. Secondary outcomes are carriage at 6, 12 and 18 months of age and the comparative immunogenicity of the different schedules in terms of antibody responses, functional antibody responses and memory B cell responses.Ethics and disseminationEthical approval has been obtained from the Human Research Ethics Committee of the Royal Children’s Hospital Melbourne and the Vietnam Ministry of Health Ethics Committee. The results, interpretation and conclusions will be presented to parents and guardians, at national and international conferences and published in peer-reviewed open access journals.Trial registration numberNCT03098628.

scholarly journals A community-based intervention to prevent serious complications and death 2 years after discharge in people with spinal cord injury in Bangladesh (CIVIC): a randomised trial

Spinal Cord ◽  
2020 ◽  
Author(s):  
Mohammad Sohrab Hossain ◽  
Lisa A. Harvey ◽  
Md. Shofiqul Islam ◽  
Md. Akhlasur Rahman ◽  
Stephen Muldoon ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Based ◽  
Phone Calls ◽  
Cord Injury ◽  
Randomised Controlled

Abstract Study design Randomised controlled trial. Objectives To determine the effectiveness of a sustainable community-based intervention designed to prevent serious complications and death 2 years after discharge in people with spinal cord injury in Bangladesh. Setting Bangladesh. Methods A pragmatic randomised controlled trial was undertaken. People who had sustained a spinal cord injury in the preceding 2 years, were wheelchair-dependent, and were about to be discharged from hospital in Bangladesh were recruited and randomised to an Intervention or Control group using a concealed allocation procedure stratified by level of lesion (tetraplegia/paraplegia). Participants in the Intervention group received 36 phone calls and three home visits over the first 2 years following discharge. All participants received usual post-discharge care. Survival status and date of death were determined by blinded assessors 2 years after randomisation. Results Between July 2015 and March 2018, 410 participants were randomised (204 to Intervention, 206 to Control). There was no loss to follow up. At 2 years, 15 (7.4%) participants in the Intervention group and 16 (7.8%) participants in the Control group had died (hazard ratio from unadjusted Cox model = 0.93 [95% CI, 0.46 to 1.89]; p from log rank test 0.85). There were no clinically important or statistically significant average causal effects of intervention on the incidence or severity of complications. Conclusion A program of community-based care for people with recent spinal cord injury in Bangladesh involving frequent phone contact and occasional in-person contact with a health professional after discharge from hospital is no better at preventing death at 2 years than usual care.

scholarly journals Study protocol for a single-blind randomised controlled trial to evaluate the clinical effects of an Integrated Qigong exercise intervention on freezing of gait in Parkinson’s disease

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e028869 ◽  
Author(s):  
Zhenlan Li ◽  
Jie Zhuang ◽  
Yan Jiang ◽  
Guiping Xiao ◽  
Kuncheng Jie ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Randomised Controlled Trial ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Freezing Of Gait ◽  
Balance Training ◽  
Control Group ◽  
Clinical Effects ◽  
Randomised Controlled ◽  
Single Blind

IntroductionQigong exercise offers a potentially safe, low-cost and effective mind–body rehabilitative intervention for mitigating the problem of gait interruption among patients with Parkinson’s disease (PD) who have frequent freezing of gait (FOG) episodes. However, its clinical effects have not been established. This paper describes the trial protocol of evaluating the clinical efficacy of a newly developed Integrated Qigong in improving gait among patients with PD who have FOG.Methods and analysisA single-blind randomised controlled trial is designed to compare Integrated Qigong and balance training with an attention control. Participants will be patients with mild to moderate PD who experience FOG and are recruited from local communities in Shanghai, China. Participants will be randomly allocated to one of the three groups: Integrated Qigong group, a balance exercise intervention group, or control group. The total number of participants will be 126, and masked assessments will be made at baseline, 12 weeks (end of intervention) and 12-week follow-up. Both Integrated Qigong group and balance training group will receive a group-based exercise intervention that meets three times per week, 60 min in duration, for 12 weeks. The control group will receive a 60 min weekly group session and monthly health education. The primary outcomes are gait parameters (stride length, gait velocity, stride time variability) and occurrence of FOG. The secondary outcomes are postural instability, walking disability, falling, fear of falling and quality of life.Ethics and disseminationThis study has been approved by the Ethics Committee of Shanghai University of Sport and registered at China Clinical Trial Registry. Participants will sign informed consent prior to the participation of the trial. The findings of the study will be published in peer-reviewed academic journals and disseminated to PD support groups, medical community and media.Trial registration numberChiCTR1800016570.

scholarly journals Effects of an actual insulin injection demonstration on insulin acceptance among patients with T2DM: a pragmatic randomised controlled trial

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Atthayaporn Choomai ◽  
Apichai Wattanapisit ◽  
Orathai Tiangtam
Keyword(s):  
Randomised Controlled Trial ◽  
Adverse Effects ◽  
Controlled Trial ◽  
Intervention Group ◽  
Insulin Injection ◽  
Educational Programme ◽  
Control Group ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial ◽  
Hba1c Levels

AbstractIntroduction. Insulin injection refusal is a challenge when initiating insulin therapy. This study aimed to investigate the effects of an actual insulin injection demonstration on insulin acceptance in patients with type 2 diabetes mellitus (T2DM).Methods. A pragmatic randomised controlled trial (RCT) was conducted. The participants were patients with T2DM aged 18–65 years old. The control group (CG) received an educational programme regarding T2DM. The intervention group (IG) received the educational programme and actual insulin injection demonstration (a physician-led sample insulin injection using an insulin pen). The main outcome was immediate insulin acceptance. Insulin adherence, glycated haemoglobin (HbA1c), and adverse effects of insulin were evaluated at three months after the intervention.Results. Forty-nine participants with T2DM were allocated to the IG (n=24) and the CG (n=25). The immediate insulin acceptance was significantly higher in the IG (79.17%, n=19) than the CG (24.00%, n=6; p---lt---0.05; RR 3.30, 95%CI 1.59 to 6.82). At the three-month follow-up, the insulin adherence was significantly different between the two groups (IG: 75.00%, n=18 vs CG: 20.00%, n=5; p---lt---0.05; RR 3.75, 95%CI 1.66 to 8.49). Adverse effects of insulin, HbA1c levels, and changes in HbA1c levels between the IG and CG were not different.Conclusion. The physician-led actual insulin injection demonstration is effective for increasing insulin acceptance among participants with T2DM.

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