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.

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 Protocol for process evaluation of CIVIC randomised controlled trial: Community-based InterVentions to prevent serIous Complications following spinal cord injury in Bangladesh

BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e024226 ◽  
Author(s):  
Mohammad Sohrab Hossain ◽  
Lisa A Harvey ◽  
Hueiming Liu ◽  
Md. Shofiqul Islam ◽  
Md. Akhlasur Rahman ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Process Evaluation ◽  
Low Income ◽  
Quantitative Data ◽  
Healthcare Professionals ◽  
Controlled Trial ◽  
Ethics Committee ◽  
Middle Income ◽  
Middle Income Countries ◽  
Randomised Controlled

IntroductionPeople with spinal cord injuries in low-income and middle-income countries are highly vulnerable to life-threatening complications in the period immediately after discharge from hospital. We are conducting a randomised controlled trial in Bangladesh to determine whether all-cause mortality at 2 years can be reduced if health professionals regularly ring and visit participants in their homes following discharge. We will conduct a process evaluation alongside the trial to explain the trial results and determine the feasibility of scaling this intervention up in low-income and middle-income countries if it is found to be effective.Methods and analysisOur process evaluation is based on the Realist and Reach, Effectiveness, Adoption, Implementation and Maintenance frameworks. We will use a mixed methods approach that uses both qualitative and quantitative data. For example, we will audit a sample of telephone interactions between intervention participants and the healthcare professionals, and we will conduct semistructured interviews with people reflective of various interest groups. Quantitative data will also be collected to determine the number and length of interactions between the healthcare professionals and participants, the types of issues identified during each interaction and the nature of the support and advice provided by the healthcare professionals. All quantitative and qualitative data will be analysed iteratively before the final analysis of the trial results. These data will then be triangulated with the final results of the primary outcome.Ethics and disseminationEthics approval was obtained from the institutional ethics committee at the site in Bangladesh and from the University of Sydney, Australia. The study will be conducted in compliance with all stipulations of its protocol, the conditions of ethics committee approval and the relevant regulatory bodies. The results of the trial will be disseminated through publications in peer-reviewed scientific journals and presentations at scientific conferences.Trial registration numberACTRN12615000630516.

scholarly journals The Effects of Time-Restricted Eating versus Standard Dietary Advice on Weight, Metabolic Health and the Consumption of Processed Food: A Pragmatic Randomised Controlled Trial in Community-Based Adults

Nutrients ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 1042
Author(s):  
Nicholas Phillips ◽  
Julie Mareschal ◽  
Nathalie Schwab ◽  
Emily Manoogian ◽  
Sylvie Borloz ◽  
...  
Keyword(s):  
Weight Loss ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Smartphone Application ◽  
Metabolic Health ◽  
Dietary Advice ◽  
Processed Food ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

Weight loss is key to controlling the increasing prevalence of metabolic syndrome (MS) and its components, i.e., central obesity, hypertension, prediabetes and dyslipidaemia. The goals of our study were two-fold. First, we characterised the relationships between eating duration, unprocessed and processed food consumption and metabolic health. During 4 weeks of observation, 213 adults used a smartphone application to record food and drink consumption, which was annotated for food processing levels following the NOVA classification. Low consumption of unprocessed food and low physical activity showed significant associations with multiple MS components. Second, in a pragmatic randomised controlled trial, we compared the metabolic benefits of 12 h time-restricted eating (TRE) to standard dietary advice (SDA) in 54 adults with an eating duration > 14 h and at least one MS component. After 6 months, those randomised to TRE lost 1.6% of initial body weight (SD 2.9, p = 0.01), compared to the absence of weight loss with SDA (−1.1%, SD 3.5, p = 0.19). There was no significant difference in weight loss between TRE and SDA (between-group difference −0.88%, 95% confidence interval −3.1 to 1.3, p = 0.43). Our results show the potential of smartphone records to predict metabolic health and highlight that further research is needed to improve individual responses to TRE such as a shorter eating window or its actual clock time.

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