Protocol for the e-POWUS Project: multicentre blinded-randomised controlled trial of ultrasound speed choice to improve sonography quality in pregnant women with obesity

IntroductionDuring pregnancy, maternal obesity increases the risk of fetal abnormalities. Despite advances in ultrasound imaging, the assessment of fetal anatomy is less thorough among these women. Currently, the construction of ultrasound images uses a conventional ultrasound propagation velocity (1540 m/s), which does not correspond to the slower speed of propagation in fat tissue.The main objective of this randomised study is to compare the completeness of fetal ultrasonography according to whether the operator could choose the ultrasound velocity (1420, 1480 or 1540 m/s) or was required to apply the 1540 m/s velocity.Methods and analysisThis randomised trial is an impact study to compare a diagnostic innovation with the reference technique. The trial inclusion criteria require that a pregnant woman with obesity be undergoing a fetal morphology examination by ultrasound from 20+0 to 25+0 gestational weeks.Randomisation will allocate women into two groups. The first will be the ‘modulable speed’ group, in which operators can choose the speed of ultrasound propagation to be considered for the morphological analysis: 1420, 1480 or 1540 m/s. In the second ‘conventional speed’ group, operators will perform the morphological examination with the ultrasound speed fixed at 1540 m/s. The adjudication committee, two independent experts, will validate the completeness of each examination and the quality of the images.Ethics and disseminationThis research protocol does not change the standard management. The only possible impact is an improvement of the ultrasound examination by improving the quality of the image and the completeness of morphological examination. The Agence du Médicament et produits de santé approved this study (2018-A03478-47). The anonymised data will be available on request from the principal investigator. Results will be reported in peer-reviewed journals and at scientific meetings.Trial registration numberClinicalTrials.gov (http://www.clinicaltrials.gov) Registry (NCT04212234).

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Study protocol of a randomised controlled trial of prostate radiotherapy in high-risk and node-positive disease comparing moderate and extreme hypofractionation (PRIME TRIAL)

BMJ Open ◽

10.1136/bmjopen-2019-034623 ◽

2020 ◽

Vol 10 (2) ◽

pp. e034623

Author(s):

Vedang Murthy ◽

Indranil Mallick ◽

Abhilash Gavarraju ◽

Shwetabh Sinha ◽

Rahul Krishnatry ◽

...

Keyword(s):

Quality Of Life ◽

Prostate Cancer ◽

High Risk ◽

Controlled Trial ◽

Randomised Trial ◽

Cancer Specific Survival ◽

Image Guided Radiotherapy ◽

Node Positive ◽

Link Type

IntroductionThere has been an interest in studying the efficacy of extreme hypofractionation in low and intermediate risk prostate cancer utilising the low alpha/beta ratio of prostate. Its role in high-risk and node-positive prostate cancer, however, is unknown. We hypothesise that a five-fraction schedule of extreme hypofractionation will be non-inferior to a moderately hypofractionated regimen over 5 weeks in efficacy and will have acceptable toxicity and quality of life while reducing the cost implications during treatment.Methods and analysisThis is an ongoing, non-inferiority, multicentre, randomised trial (NCT03561961) of two schedules for National Cancer Control Network high-risk and/or node-positive non-metastatic carcinoma of the prostate. The standard arm will be a schedule of 68 Gy/25# over 5 weeks while the test arm will be extremely hypofractionated radiotherapy with stereotactic body radiation therapy to 36.25 Gy/5# (7 to 10 days). The block randomisation will be stratified by nodal status (N0/N+), hormonal therapy (luteinizing hormone-releasing hormone therapy/orchiectomy) and centre. All patients will receive daily image-guided radiotherapy.The primary end point is 4-year biochemical failure free survival (BFFS). The power calculations assume 4-year BFFS of 80% in the moderate hypofractionation arm. With a 5% one-sided significance and 80% power, a total of 434 patients will be randomised to both arms equally (217 in each arm). The secondary end points include overall survival, prostate cancer specific survival, acute and late toxicities, quality of life and out-of-pocket expenditure.DiscussionThe trial aims to establish a therapeutically efficacious and cost-efficient modality for high-risk and node-positive prostate cancer with an acceptable toxicity profile. Presently, this is the only trial evaluating and answering such a question in this cohort.Ethics and disseminationThe trial has been approved by IEC-III of Tata Memorial Centre, Mumbai.Trial registration numberRegistered with CTRI/2018/05/014054 (http://ctri.nic.in) on 24 May 2018

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Mesothelioma and Radical Surgery 2 (MARS 2): protocol for a multicentre randomised trial comparing (extended) pleurectomy decortication versus no (extended) pleurectomy decortication for patients with malignant pleural mesothelioma

BMJ Open ◽

10.1136/bmjopen-2020-038892 ◽

2020 ◽

Vol 10 (9) ◽

pp. e038892

Author(s):

Eric Lim ◽

Liz Darlison ◽

John Edwards ◽

Daisy Elliott ◽

D A Fennell ◽

...

Keyword(s):

Quality Of Life ◽

Research Ethics ◽

Controlled Trial ◽

Randomised Trial ◽

Progression Free Survival ◽

Standard Of Care ◽

Pleural Mesothelioma ◽

Platinum Drug ◽

Link Type

IntroductionMesothelioma remains a lethal cancer. To date, systemic therapy with pemetrexed and a platinum drug remains the only licensed standard of care. As the median survival for patients with mesothelioma is 12.1 months, surgery is an important consideration to improve survival and/or quality of life. Currently, only two surgical trials have been performed which found that neither extensive (extra-pleural pneumonectomy) or limited (partial pleurectomy) surgery improved survival (although there was some evidence of improved quality of life). Therefore, clinicians are now looking to evaluate pleurectomy decortication, the only radical treatment option left.Methods and analysisThe MARS 2 study is a UK multicentre open parallel group randomised controlled trial comparing the effectiveness and cost-effectiveness of surgery—(extended) pleurectomy decortication—versus no surgery for the treatment of pleural mesothelioma. The study will test the hypothesis that surgery and chemotherapy is superior to chemotherapy alone with respect to overall survival. Secondary outcomes include health-related quality of life, progression-free survival, measures of safety (adverse events) and resource use to 2 years. The QuinteT Recruitment Intervention is integrated into the trial to optimise recruitment.Ethics and disseminationResearch ethics approval was granted by London – Camberwell St. Giles Research Ethics Committee (reference 13/LO/1481) on 7 November 2013. We will submit the results for publication in a peer-reviewed journal.Trial registration numbersISRCTN—ISRCTN44351742 and ClinicalTrials.gov—NCT02040272.

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Pelargonium sidoides root extract for the treatment of acute cough due to lower respiratory tract infection in adults: a feasibility double-blind, placebo-controlled randomised trial

BMC Complementary Medicine and Therapies ◽

10.1186/s12906-021-03206-4 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Merlin Willcox ◽

Catherine Simpson ◽

Sam Wilding ◽

Beth Stuart ◽

Dia Soilemezi ◽

...

Keyword(s):

Primary Care ◽

Controlled Trial ◽

Randomised Trial ◽

Acute Bronchitis ◽

Antibiotic Prescribing ◽

Root Extract ◽

Double Blind ◽

Double Blind Placebo ◽

Link Type ◽

Pelargonium Sidoides

Abstract Background Pelargonium sidoides DC (Geraniaceae) root extract, EPs®7630 or “Kaloba®”, is a widely used herbal remedy for respiratory infections, with some evidence of effectiveness for acute bronchitis. However, it is not yet widely recommended by medical professionals in the UK. There is a need to undertake appropriately designed randomised trials to test its use as an alternative to antibiotics. The aim was to assess the feasibility of conducting a double-blind randomised controlled trial of Pelargonium sidoides root extract for treatment of acute bronchitis in UK primary care, investigating intervention compliance, patient preference for dosage form and acceptability of patient diaries. Study design Feasibility double-blind randomised placebo-controlled clinical trial. Methods We aimed to recruit 160 patients with cough (≤ 21 days) caused by acute bronchitis from UK general practices. Practices were cluster-randomised to liquid or tablet preparations and patients were individually randomised to Kaloba® or placebo. We followed participants up for 28 days through self-reported patient diaries with telephone support and reviewed medical records at one month. Outcomes included recruitment, withdrawal, safety, reconsultation and symptom diary completion rates. We also assessed treatment adherence, antibiotic prescribing and consumption, mean symptom severity (at days 2–4 after randomisation) and time to symptom resolution. We interviewed 29 patients and 11 health professionals to identify barriers and facilitators to running such a randomised trial. Results Of 543 patients screened, 261 were eligible, of whom 134 (51%) were recruited and 103 (77%) returned a completed diary. Overall, 41% (41/100) of patients took antibiotics (Kaloba® liquid group: 48% [15/31]; placebo liquid group: 23% [6/26]; Kaloba® tablet group: 48% [9/21]; placebo tablet group: 50% [11/22]). Most patients adhered to the study medication (median 19 out of 21 doses taken in week 1, IQR 18–21 - all arms combined). There were no serious adverse events relating to treatment. Most patients interviewed found study recruitment to be straightforward, but some found the diary too complex. Conclusions It was feasible and acceptable to recruit patients from UK primary care to a double-blind placebo-controlled trial of herbal medicine (Kaloba®) for the treatment of acute bronchitis, with good retention and low data attrition. Trial registration HATRIC was registered on the ISRCTN registry (ISRCTN17672884) on 16 August 2018, retrospectively registered. The record can be found at http://www.isrctn.com/ISRCTN17672884.

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A Randomised Controlled Trial of the Effect of Esmarch Tourniquet Use on Blood Loss, Bruising and Quality of Life in Elective Varicose Vein Surgery

Phlebology The Journal of Venous Disease ◽

10.1177/026835550201700104 ◽

2002 ◽

Vol 17 (1) ◽

pp. 10-12

Author(s):

A. Fowler ◽

M. Stechman ◽

D. Mitchell

Keyword(s):

Quality Of Life ◽

Blood Loss ◽

Varicose Vein ◽

Controlled Trial ◽

Randomised Trial ◽

Varicose Vein Surgery ◽

Clinical Value ◽

Prospective Randomised Trial ◽

Randomised Controlled

Objective: To assess the effect of tourniquet use on bleeding, bruising and quality of life in varicose vein surgery. Method: A prospective randomised trial of 49 patients undergoing varicose vein surgery was carried out. All patients were having single leg surgery as a day case. Blood loss was assessed by weighing swabs. Bruising was measured at 10 days, and quality of life assessed with SF36 questionaires. Synthesis: In the tourniquet group blood loss was significantly reduced but not the area of bruising. The SF36 scores showed deterioration in the non-tourniquet group at 10 days but this was not present at 6 weeks. We saw no complications of tourniquet use but the study was limited by disappointing recruitment reducing the power. Conclusion: Tourniquet use may be of clinical value. A larger study is required to assess the significance.

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Promoting Independence in Dementia (PRIDE): protocol for a feasibility randomised controlled trial

Trials ◽

10.1186/s13063-019-3838-x ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 1

Author(s):

Aisha Shafayat ◽

Emese Csipke ◽

Lucy Bradshaw ◽

Georgina Charlesworth ◽

Florence Day ◽

...

Keyword(s):

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Usual Care ◽

Rating Scale ◽

Controlled Trial ◽

Randomised Trial ◽

Mild Dementia ◽

Link Type ◽

Feasibility Randomised Controlled Trial ◽

Randomised Controlled

Abstract Background Memory services often see people with early stage dementia who are largely independent and able to participate in community activities but who run the risk of reducing activities and social networks. PRIDE is a self-management intervention designed to promote living well and enhance independence for people with mild dementia. This study aims to examine the feasibility of conducting a definitive randomised trial comparing the clinical and cost-effectiveness of the PRIDE intervention offered in addition to usual care or with usual care alone. Methods/design PRIDE is a parallel, two-arm, multicentre, feasibility, randomised controlled trial (RCT). Eligible participants aged 18 or over who have mild dementia (defined as a score of 0.5 or 1 on the Clinical Dementia Rating Scale) who can participate in the intervention and provide informed consent will be randomised (1:1) to treatment with the PRIDE intervention delivered in addition to usual care, or usual care only. Participants will be followed-up at 3 and 6 month’s post-randomisation. There will be an option for a supporter to join each participant. Each supporter will be provided with questionnaires at baseline and follow-ups at 3 to 6 months. Embedded qualitative research with both participants and supporters will explore their perspectives on the intervention investigating a range of themes including acceptability and barriers and facilitators to delivery and participation. The feasibility of conducting a full RCT associated with participant recruitment and follow-up of both conditions, intervention delivery including the recruitment, training, retention of PRIDE trained facilitators, clinical outcomes, intervention and resource use costs and the acceptability of the intervention and study related procedures will be examined. Discussion This study will assess whether a definitive randomised trial comparing the clinical and cost-effectiveness of whether the PRIDE intervention offered in addition to usual care is feasible in comparison to usual care alone, and if so, will provide data to inform the design and conduct of a future trial. Trial registration ISRCTN, ISRCTN11288961, registered on 23 October 2019, http://www.isrctn.com/ISRCTN12345678 Protocol V2.1 dated 19 June 2019.

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Feasibility, experiences and outcomes of using DIALOG+ in primary care to improve quality of life and mental distress of patients with chronic conditions: an exploratory non-controlled trial in Bosnia and Herzegovina, Colombia and Uganda

Pilot and Feasibility Studies ◽

10.1186/s40814-021-00914-z ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Francois van Loggerenberg ◽

Michael McGrath ◽

Dickens Akena ◽

Harriet Birabwa-Oketcho ◽

Camilo Andrés Cabarique Méndez ◽

...

Keyword(s):

Quality Of Life ◽

Primary Care ◽

Bosnia And Herzegovina ◽

Mental Distress ◽

Controlled Trial ◽

Physical Conditions ◽

Link Type ◽

Primary Care Settings ◽

Chronic Physical Conditions

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).

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416 A NARRATIVE SYSTEMATIC REVIEW OF POSTOPERATIVE REHABILITATION FOLLOWING SURGERY FOR ESOPHAGEAL CANCER

Diseases of the Esophagus ◽

10.1093/dote/doaa087.105 ◽

2020 ◽

Vol 33 (Supplement_1) ◽

Author(s):

P Prasad ◽

K Hardy ◽

J Chmelo ◽

M Navidi ◽

A Phillips

Keyword(s):

Quality Of Life ◽

Systematic Review ◽

Positive Impact ◽

Controlled Trial ◽

Randomised Trial ◽

Risk Of Bias ◽

Moderate Intensity ◽

Cochrane Library ◽

The Impact

Abstract Esophagectomy is a complex procedure with associated high levels of morbidity. Rehabilitation programmes are being developed and increasingly utilised in the perioperative period and comprise a variety of physical, nutritional and psychological interventions. Such strategies may help reduce the incidence of postoperative complications, mitigate sarcopenia, prevent progressive frailty and restore quality of life. This systematic review aimed to identify and analyse studies reporting outcomes of post-esophagectomy rehabilitative interventions. Methods Major reference databases (PubMed, Medline, EMBASE, Cochrane Library and Google scholar) were interrogated and a systematic search with a pre-defined search strategy was performed up until January 2020. All eligible articles were screened in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Study quality was assessed using the MINORS (Methodological Index for Non-Randomized Studies) criteria for cohort studies and the Cochrane risk of bias tool for randomised studies. Results Three studies (n = 1 pilot study; n = 1 feasibility study and n = 1 randomised controlled trial) including some 108 patients were included in this narrative review, of whom 64 patients had undergone esophagectomy. Rehabilitative strategies utilised included a combination of physical activities such as walking and low- to moderate-intensity exercises, dietary counselling, psychological support and occupational therapy input. There was wide variation in the outcomes assessed between studies. Postoperative physical activity with exercises consistently demonstrated maximum positive impact upon cardiopulmonary fitness. The median MINORS score for included studies was 9 (8-10) and the risk of bias in the included randomised trial was low. Conclusion There is a paucity of data currently to help determine the impact that rehabilitation may have on clinical outcomes and quality of life following esophagectomy. While improved physical function has been demonstrated, there is a need to determine which interventions patients deem most important and acceptable to help them return to as close to baseline as possible. Additionally, there is a need to further understand the impact rehabilitation may have upon long-term outcomes.

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Efficacy of modified Banxia Xiexin decoction in the management of Wei-Pi syndrome (postprandial distress syndrome): study protocol for a randomized, waitlist-controlled trial

Trials ◽

10.1186/s13063-021-05078-y ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Sai Ho Sin ◽

Jing Wu ◽

Yuchen Kang ◽

Kar Hung Kevin Yip ◽

Ngo Suet Kong ◽

...

Keyword(s):

Quality Of Life ◽

Distress Syndrome ◽

Controlled Trial ◽

Control Group ◽

Waitlist Control ◽

Link Type ◽

Waitlist Control Group ◽

Banxia Xiexin Decoction

Abstract Background Postprandial distress syndrome manifests as a feeling of fullness and early satiation that can significantly reduce the quality of life of the patients. In Chinese medicine (CM), the syndrome is traditionally regarded as the Wei-Pi syndrome, and Banxia Xiexin decoction (BXD) has been used in the empirical treatment of the same for a long time. The current study aims to evaluate the efficacy of modified BXD in the management of Wei-Pi syndrome. Methods/design A randomized, waitlist-controlled trial will be conducted. A total of 84 patients with Wei-Pi syndrome will be randomized into the BXD or waitlist control group in a ratio of 1:1. The patients in the BXD group will receive the semi-individualized BXD on the basis of the syndrome differentiation in CM, for a duration of 3 weeks and will be under follow-up for further 3 weeks after the completion of therapy. Conversely, the patients in the waitlist control group will undergo the same intervention and follow-up after a 3-week waiting period. In the current study, the primary outcome will be the variation in the scores pertaining to the global scale of the Quality of Life Questionnaire for Functional Digestive Disorders after 3 weeks. The secondary outcomes include the variations in the scores pertaining to the Hospital Anxiety and Depression Scale and the EuroQoL 5-dimension 5-level Questionnaire and the results of the liver and kidney function tests. Discussion This trial will assess the efficacy of modified BXD in improving the clinical symptoms and quality of life of the patients suffering from Wei-Pi syndrome. Trial registration ClinicalTrials.govNCT04398888. Registered on May 21, 2020

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An individual randomised efficacy trial of autologous blood products, leukocyte and platelet-rich fibrin (L-PRF), to promote ulcer healing in leprosy in Nepal: the TABLE trial protocol

Trials ◽

10.1186/s13063-021-05392-5 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Indra B. Napit ◽

Dilip Shrestha ◽

Jon Bishop ◽

Sopna Choudhury ◽

Santosh Dulal ◽

...

Keyword(s):

Low Income ◽

Ulcer Healing ◽

Controlled Trial ◽

Autologous Blood ◽

Foot Ulcer ◽

Low Income Countries ◽

Platelet Rich Fibrin ◽

Link Type ◽

Single Centre Study

Abstract Background Leprosy is curable with multidrug therapy and treatment in the early stages can prevent disability. However, local nerve damage can lead to injury and consequently recurring and disfiguring ulcers. The aim of this study is to evaluate the treatment of leprosy ulcers using an autologous blood product; leukocyte and platelet-rich fibrin (L-PRF) to promote healing. Methods This is a single-centre study in the Anandaban Hospital, The Leprosy Mission Nepal, Kathmandu, Nepal. Consenting patients (n=130) will be individually randomised in a single-blinded, controlled trial. Participants will be 18 years of age or older, admitted to the hospital with a clean, dry and infection-free chronic foot ulcer between 2 and 20 cm2 in size. If the ulcer is infected, it will be treated before enrolment into the study. The intervention involves the application of leukocyte and platelet-rich fibrin (L-PRF) matrix on the ulcer beds during twice-weekly dressing changes. Controls receive usual care in the form of saline dressings only during their twice-weekly dressing changes. Primary outcomes are the rate of healing assessed using standardised photographs by observers blind to allocated treatment, and time to complete re-epithelialization. Follow-up is at 6 months from randomisation. Discussion This research will provide valuable information on the clinical and cost-effectiveness of L-PRF in the treatment of leprosy ulcers. An additional benefit is the evaluation of the effects of treatment on quality of life for people living with leprosy ulcers. The results will improve our understanding of the scalability of this treatment across low-income countries for ulcer healing in leprosy and potentially other conditions such as diabetic ulcers. Trial registration ClinicalTrials.govISRCTN14933421. Registered on 16 June 2020

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IMPROV-ED trial: eHealth programme for faster recovery and reduced healthcare utilisation after CABG

Netherlands Heart Journal ◽

10.1007/s12471-020-01508-9 ◽

2020 ◽

Author(s):

G. J. van Steenbergen ◽

D. van Veghel ◽

J. ter Woorst ◽

D. van Lieshout ◽

L. Dekker

Keyword(s):

Quality Of Life ◽

Patient Satisfaction ◽

Controlled Trial ◽

Artery Bypass ◽

Randomised Trial ◽

Intervention Group ◽

Healthcare Utilisation ◽

Control Group ◽

Randomised Controlled

Abstract Background After coronary artery bypass grafting (CABG), healthcare utilisation is high and is partly unplanned. eHealth applications have been proposed to reduce healthcare consumption and to enable patients to get actively involved in their recovery. This way, healthcare expenses can be reduced and the quality of care can be improved. Objectives We aim to evaluate whether the use of an eHealth programme can reduce unplanned healthcare utilisation and improve mental and physical health in the first 6 weeks after discharge in patients who underwent CABG. In addition, patient satisfaction and use of the eHealth programme will be evaluated. Methods For this single-centre randomised controlled trial, at least 280 patients referred for CABG will be included at the preoperative outpatient clinic and randomised to an intervention or control group. The intervention group will have access to an eHealth programme, which consists of online educational videos developed by the Dutch Heart Foundation and postoperative video consultations with a physician. The control group will receive standard care and will not have access to the eHealth programme. The primary endpoint is healthcare utilisation; other endpoints include anxiety, duration of recovery, quality of life and patient satisfaction. Participants will complete several questionnaires at 6 time points during the study. Results Patient enrolment started in February 2020 and completion of the follow-up period is expected in August 2021. Conclusion This randomised trial was initiated to test the hypothesis that patients who are partaking in our eHealth programme use less unplanned care and experience a better quality of life, less anxiety and a faster recovery than controls.

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