World Health Organization Trial Registration Research Articles

Study protocol for a pragmatic randomised controlled trial of comparing enhanced acceptance and commitment therapy plus (+) added to usual aftercare versus usual aftercare only, in patients living with or beyond cancer: SUrvivors’ Rehabilitation Evaluation after CANcer (SURECAN) trial

BackgroundTwo million people in the UK are living with or beyond cancer and a third of them report poor quality of life (QoL) due to problems such as fatigue, fear of cancer recurrence, and concerns about returning to work. We aimed to develop and evaluate an intervention based on acceptance and commitment therapy (ACT), suited to address the concerns of cancer survivors and in improving their QoL. We also recognise the importance of exercise and vocational activity on QoL and therefore will integrate options for physical activity and return to work/vocational support, thus ACT Plus (+).MethodsWe will conduct a multi-centre, pragmatic, theory driven, randomised controlled trial. We will assess whether ACT+ including usual aftercare (intervention) is more effective and cost-effective than usual aftercare alone (control). The primary outcome is QoL of participants living with or beyond cancer measured using the Functional Assessment of Cancer Therapy: General scale (FACT-G) at 52 weeks. We will recruit 344 participants identified from secondary care sites who have completed hospital-based treatment for cancer with curative intent, with low QoL (determined by the FACT-G) and randomise with an allocation ratio of 1:1 to the intervention or control. The intervention (ACT+) will be delivered by NHS Talking Therapies, specialist services, and cancer charities. The intervention consists of up to eight sessions at weekly or fortnightly intervals using different modalities of delivery to suit individual needs, i.e. face-to-face sessions, over the phone or skype.DiscussionTo date, there have been no robust trials reporting both clinical and cost-effectiveness of an ACT based intervention for people with low QoL after curative cancer treatment in the UK. We will provide high quality evidence of the effectiveness and cost-effectiveness of adding ACT+ to usual aftercare provided by the NHS. If shown to be effective and cost-effective then commissioners, providers and cancer charities will know how to improve QoL in cancer survivors and their families.Trial registrationISRCTN: ISRCTN67900293. Registered on 09 December 2019.All items from the World Health Organization Trial Registration Data Set for this protocol can be found in Additional file 2 Table S1.

Development of a multidisciplinary medication management program in nursing homes: protocol for a randomized controlled trial

BackgroundPolypharmacy and the use of potentially inappropriate medications are common among nursing home residents and are associated with negative outcomes. Although deprescribing has been proposed as a way to curtail these problems, the best way to implement multidisciplinary comprehensive medication review and deprescribing and its real impact in specific high-risk populations, such as nursing home residents, is still unclear. This multicenter randomized controlled clinical trial aims to assess the effects of a multidisciplinary mediation management program on medication use and health problems.MethodsA total of 1,672 residents aged ≥ 65 years from 22 nursing homes in South Korea who meet the targeted criteria, such as the use of ≥ 10 medications, are eligible to participate. The experimental group will receive a comprehensive medication review, deprescription, and multidisciplinary case conference with the help of platform. Outcomes will be measured at baseline, at the end of the intervention, as well as at 3, 6, 9, and 12 months after the end of the intervention. The primary endpoints will be the rate of adverse drug events, number of potentially inappropriate medications/potentially inappropriate medication users/two or more central nervous system drug/ central nervous system drug users, delirium, emergency department visits, hospitalization, and falls. The secondary endpoint will be the number of medications taken and polypharmacy users.DiscussionOur trial design is unique in that it aims to introduce a structured operationalized clinical program focused on reducing polypharmacy and potentially inappropriate medications in a nursing home setting with large samples.Trial registrationEthical approval was granted by the public institutional review board of the Ministry of Health and Welfare (2022-1092-009). The study is also registered with the Clinical Research Information Service (Identifier: KCT0008157, Development and evaluation of a multidisciplinary medication management program in long-term care facility residents Status: Approved First Submitted Date: 2023/01/18 Registered Date: 2023/02/03 Last Updated Date: 2023/01/18 (nih.go.kr) https://cris.nih.go.kr/), which includes all items from the World Health Organization Trial Registration Dataset.

Usability of an App for Medical History Taking in General Practice From the Patients' Perspective: Cross-Sectional Study.

A future shortage of physicians, especially in general practice, will result in an increasing workload for health care providers as a whole. Therefore, it is important to optimize patient-encounter processes to increase time efficiency related to visits. Utilizing digital tools to record patients' medical histories prior to a consultation offers great potential to achieve this goal. The collected information can be stored into the practice's electronic medical record, allowing for the general practitioner to review structured information of the patients' complaints and related medical history beforehand, thereby saving time during the encounter. However, the low usability of new digital developments in this setting often hinders implementation. The aim of this study was to evaluate the usability of an app designed for medical history taking in general practice to capture the patients' perspective. Between November 2021 and January 2022, we recruited 406 patients with acute complaints in one out-of-hour urgent care and seven general practice clinics. These study participants used the app during their waiting time and subsequently assessed its usability by completing the System Usability Scale (SUS), a robust and well-established 10-question survey measuring the perceived usability of products and technologies. Additionally, we collected general participant information, including age, sex, media usage, health literacy, and native language. Descriptive and inferential statistics were applied to identify patient characteristics associated with low or high SUS scores. We analyzed data from 397 patients (56.7% female, 43.3% male). The mean total SUS score was 77.8 points; 54.4% (216/397) of participants had SUS scores of 80 points or higher, indicating high usability of the app. In a multiple linear regression predicting SUS score, male sex and higher age (65 years or older) were significantly negatively associated with the SUS score. Conversely, a higher health literacy score and German as the native language were significantly positively associated with the SUS score. Usability testing based on the SUS anticipates successful implementation of the app. However, not all patients will easily adapt to utilizing the app, as exemplified by the participants of older age in this study who reported lower perceived usability. Further research should examine these groups of people, identify the exact problems in operating such an app, and provide targeted solutions. German Clinical Trials Register World Health Organization Trial Registration Data Set DRKS00026659; https://trialsearch.who.int/Trial2.aspx?TrialID=DRKS00026659.

Vitamin E-enriched medium cross-linked polyethylene in total knee arthroplasty (VIKEP): clinical outcome, oxidation profile, and wear analysis in comparison to standard polyethylene—study protocol for a randomized controlled trial

BackgroundThe gliding surface of total knee endoprostheses is exposed to high loads due to patient weight and activity. These implant components are typically manufactured from ultra-high molecular weight polyethylene (UHMWPE). Crosslinking of UHMWPE by ionizing radiation results in higher wear resistance but induces the formation of free radicals which impair mechanical properties after contact with oxygen. Medium-crosslinked UHMWPE enriched with vitamin E (MXE) provides a balance between the parameters for a sustainable gliding surface, i.e., mechanical strength, wear resistance, particle size, and oxidation stability. Therefore, a gliding surface for knee endoprostheses made up from this material was developed, certified, and launched. The aim of this study is to compare this new gliding surface to the established predecessor in a non-inferiority design.MethodsThis multicenter, binational randomized controlled trial will enroll patients with knee osteoarthritis eligible for knee arthroplasty with the index device. Patients will be treated with a knee endoprosthesis with either MXE or a standard gliding surface. Patients will be blinded regarding their treatment. After implantation of the devices, patients will be followed up for 10 years. Besides clinical and patient-related outcomes, radiological data will be collected. In case of revision, the gliding surface will be analyzed biomechanically and regarding the oxidative profile.DiscussionThe comparison between MXE and the standard gliding surface in this study will provide clinical data to confirm preceding biomechanical results in vivo. It is assumed that material-related differences will be identified, i.e., that the new material will be less sensitive to wear and creep. This may become obvious in biomechanical analyses of retrieved implants from revised patients and in radiologic analyses.Trial registrationClinicalTrials.gov, NCT04618016. Registered 27 October 2020, https://clinicaltrials.gov/study/NCT04618016?term=vikep&checkSpell=false&rank=1.All items from the World Health Organization Trial Registration Data Set can be found in Additional file 1.

Islamic trauma healing (ITH): A scalable, community-based program for trauma: Cluster randomized control trial design and method

BackgroundSomalia has long been in a state of humanitarian crisis; trauma-related mental health needs are extremely high. Access to state-of-the-art mental health care is limited. Islamic Trauma Healing (ITH) is a manualized mosque-based, lay-led group intervention aimed at healing the individual and communal mental wounds of war and refugee trauma. The 6-session intervention combines Islamic principles with empirically-supported exposure and cognitive restructuring principles for posttraumatic stress disorder (PTSD). ITH reduces training time, uses a train the trainers (TTT) model, and relies on local partnerships embedded within the strong communal mosque infrastructure. MethodsWe will conduct a hybrid effectiveness-implementation randomized control trial (RCT) in the Somaliland, with implementation in the cities of Hargeisa, Borama, and Burao. In this study, a lay-led, mosque-based intervention, Islamic Trauma Healing (ITH), to promote mental health and reconciliation will be examined in 200 participants, randomizing mosques to either immediate ITH or a delayed (waitlist; WL) ITH conditions. Participants will be assessed by assessors masked to condition at pre, 3 weeks, 6 weeks, and 3-month follow-up. Primary outcome will be assessor-rated posttraumatic stress symptoms (PTSD), with secondary outcomes of depression, somatic symptoms, and well-being. A TTT model will be tested, examining the implementation outcomes. Additional measures include potential mechanisms of change and cost effectiveness. ConclusionThis trial has the potential to provide effectiveness and implementation data for an empirically-based principle trauma healing program for the larger Islamic community who may not seek mental health care or does not have access to such care. Clinical trial registration numberClinicalTrials.gov NCT05890482. World health organization trial registration data set informationSee Supplemental Appendix 1.

Transcutaneous electrical vagus nerve stimulation to suppress premature ventricular complexes (TREAT PVC): study protocol for a multi-center, double-blind, randomized controlled trial

BackgroundThe autonomic nervous system can be responsible for the initiation and maintenance of arrhythmias. Low-level tragus stimulation (LLTS), a noninvasive form of autonomic neuromodulation, has been shown to be effective in treating atrial fibrillation. We intended to treat frequent premature ventricular complexes (PVCs) with LLTS.Methods and designThe present study will be a prospective multicenter, double-blind, randomized, controlled trial to assess the antiarrhythmic effects of LLTS on frequent PVCs in patients without structured heart disease (SHD). A total of 100 patients with PVC burden > 10% will be randomly assigned to the active or sham LLTS in 1:1 fashion and receive the proposed intervention for 6 months. The primary outcome is PVC burden at 6 months as assessed by 10 days of continuous ambulatory electrocardiographic monitoring. Secondary outcomes include heart rate variability (HRV), quality of life, skin sympathetic nerve activity, and inflammatory markers. Adverse events will also be recorded.DiscussionThe present trial will be the first to evaluate the effect of LLTS on frequent PVCs on patients without SHD. LLTS may serve as a low-cost, minimal-risk, and non-invasive alternative to conventional antiarrhythmic therapy.Trial registrationClinicalTrial.gov NCT04909528. Registered on 17 June 2021. World health organization trial registration data set was shown in Supplementary Table 1.

Effectiveness and safety of digital rectal stimulation and abdominal massage for neurogenic bowel dysfunction in stroke patients: a randomized controlled trial protocol

BackgroundNeurogenic bowel dysfunction (NBD) is a prevalent complication among stroke patients, significantly affecting their quality of life, duration of hospitalization, medical expenses, and even mortality. Although current guidelines suggest a conservative strategy for addressing bowel dysfunction, which includes techniques such as digital rectal stimulation (DRS) and abdominal massage, the availability of interventions remains limited in healthcare facilities.MethodsThis study follows a prospective randomized controlled parallel-group clinical trial design. The control group will receive standard care, while the intervention group will undergo a program that combines DRS and abdominal massage in addition to standard care. The duration of the intervention for both groups will be 6 weeks. The primary outcome measures will be the Wexner score. Furthermore, secondary outcomes measure will be assessed, including Bristol score, Patient Assessment of Constipation-Quality of Life (PAC-QoL), and Fecal Incontinence Quality of Life (FI-QoL).DiscussionThis study aims to evaluate the effectiveness and safety of a bowel rehabilitation program for stroke patients with NBD. The findings will provide information that can contribute to the formulation of bowel management strategies.Trial registrationThe study has been registered in the Chinese Clinical Registry under the number ChiCTR2300071709. This registration was completed on May 23, 2023. All items from the World Health Organization Trial Registration Data set are described in this manuscript.

The effects of therapeutic virtual reality experience to promote mental well-being in older people living with physical disabilities in long-term care facilities

BackgroundMental well-being is poor in long-term care facilities (LTCF) residents. Physical disabilities, impaired social engagement, and environmental stress are also common in LTCF which exacerbate the decline of the mental well-being of older people living in LTCF. Protective elements, including nature-based, reminiscence, outdoor, and group activities, are known to be effective to promote the mental well-being of older people living in LTCF. However, limited by their physical disabilities and poor social support, older people living in LTCF are not likely to benefit from these effective measures. Virtual reality has been proven to be feasible to be environmentally unrestricted to providing LTCF residents with all protective elements promoting mental well-being. However, its effects on the mental well-being of LTCF residents living with physical disabilities are unclear.MethodsThis study employs a single-blinded, two-parallel-group (intervention-to-control group ratio = 1:1), non-inferiority, randomized controlled trial. Eligible participants are aged 60 years or above, LTCF residents, and living with physical disabilities. The study will be conducted in LTCF. In the intervention group, participants will receive a 6-week VR experience program. In the control group, participants will receive the usual care provided by the LTCF. The primary outcome is mental well-being, as measured by World Health Organization Five Well-being Index at the time point of baseline (i.e., week 0) and after completion of the intervention (i.e., week 7). This study aims to recruit a total of 216 participants. Generalized estimating equations (GEE) will be used to examine the effects of the intervention.Trial registrationThe trial has been registered at ClinicalTrials.gov (Identifier: NCT05818579), Registered on April 5, 2023. The latest version of the protocol was published online on 19 April 2023. All items come from the World Health Organization Trial Registration Data Set. This study has been approved by the Research Ethics Committee of Tung Wah College, Hong Kong (reference number: REC2023158). The findings will be disseminated in peer-reviewed journals, presented at international and local conferences with related themes, and shared in local media.

An observer-blinded, cluster randomised trial of a typhoid conjugate vaccine in an urban South Indian cohort

BackgroundTyphoid fever causes nearly 110,000 deaths among 9.24 million cases globally and disproportionately affects developing countries. As a control measure in such regions, typhoid conjugate vaccines (TCVs) are recommended by the World Health Organization (WHO). We present here the protocol of a cluster randomised vaccine trial to assess the impact of introducing TyphiBEV® vaccine to those between 1 and 30 years of age in a high-burden setting.MethodsThe primary objective is to determine the relative and absolute rate reduction of symptomatic, blood-culture-confirmed S. Typhi infection among participants vaccinated with TyphiBEV® in vaccine clusters compared with the unvaccinated participants in non-vaccine clusters. The study population is residents of 30 wards of Vellore (a South Indian city) with participants between the ages of 1 and 30 years who provide informed consent. The wards will be divided into 60 contiguous clusters and 30 will be randomly selected for its participants to receive TyphiBEV® at the start of the study. No placebo/control is planned for the non-intervention clusters, which will receive the vaccine at the end of the trial. Participants will not be blinded to their intervention. Episodes of typhoid fever among participants will be captured via stimulated, passive fever surveillance in the area for 2 years after vaccination, which will include the most utilised healthcare facilities. Observers blinded to the participants’ intervention statuses will record illness details. Relative and absolute rate reductions will be calculated at the end of this surveillance and used to estimate vaccine effectiveness.DiscussionThe results from our trial will allow countries to make better-informed decisions regarding the TCV that they will roll-out and may improve the global supplies and affordability of the vaccines.Trial registrationClinical Trials Registry of India (CTRI) CTRI/2022/03/041314. Prospectively registered on 23 March 2022 (https://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=62548&EncHid=&userName=vellore%20typhoid). CTRI collects the full WHO Trial Registration Data Set.

The effects of an e-health brisk walking intervention in increasing moderate-to-vigorous physical activity in physically inactive older people with cognitive frailty: study protocol for a randomized controlled trial

BackgroundCognitive frailty is a risk for many adverse health outcomes that are commonly observed in older people. Physical activity is known to be effective to reserve cognitive frailty but the prevalence of physical inactivity is still high in older people. E-health enhances behavioural change effects through an innovative way to deliver behavioural change methods that can enhance the behavioural change effects. However, its effects on older people with cognitive frailty, its effects compared with conventional behavioural change methods, and the sustainability of the effects are unclear.MethodsThis study employs a single-blinded, two-parallel-group, non-inferiority, randomized controlled trial design with a 1:1 group allocation ratio. Eligible participants are aged 60 years or above, have cognitive frailty and physical inactivity, and possess a smartphone for more than six months. The study will be conducted in community settings. In the intervention group, participants will receive a 2-week brisk-walking training followed by a 12-week e-health intervention. In the control group, participants will receive a 2-week brisk-walking training followed by a 12-week conventional behavioural change intervention. The primary outcome is minutes of moderate-to-vigorous physical activity (MVPA). This study aims to recruit a total of 184 participants. Generalized estimating equations (GEE) will be used to examine the effects of the intervention.Ethics and disseminationThe trial has been registered at ClinicalTrials.gov (Identifier: NCT05758740) on 7th March 2023, https://clinicaltrials.gov/ct2/show/NCT05758740, and all items come from the World Health Organization Trial Registration Data Set. It has been approved by the Research Ethics Committee of Tung Wah College, Hong Kong (reference number: REC2022136). The findings will be disseminated in peer-reviewed journals and presented at international conferences relevant to the subject fields.Trial registrationThe trial has been registered at ClinicalTrials.gov (Identifier: NCT05758740) and all items come from the World Health Organization Trial Registration Data Set. The latest version of the protocol was published online on 7th March 2023.

Evaluating an app for digital medical history taking in urgent care practices: study protocol of the cluster-randomized interventional trial ‘DASI’

BackgroundIn out-of-hours urgent care practices in Germany, physicians of different specialties care for a large number of patients, most of all unknown to them, resulting in a high workload and challenging diagnostic decision-making. As there is no common patient file, physicians have no information about patients’ previous conditions or received treatments. In this setting, a digital tool for medical history taking could improve the quality of medical care. This study aims to implement and evaluate a software application (app) that takes a structured symptom-oriented medical history from patients in urgent care settings.MethodsWe conduct a time-cluster-randomized trial in two out-of-hours urgent care practices in Germany for 12 consecutive months. Each week during the study defines a cluster. We will compare participants with (intervention group) and without app use (control group) prior to consultation and provision of the self-reported information for the physician. We expect the app to improve diagnostic accuracy (primary outcome), reduce physicians’ perceived diagnostic uncertainty, and increase patients’ satisfaction and the satisfaction with communication of both physician and patient (secondary outcomes).DiscussionWhile similar tools have only been subject to small-scale pilot studies surveying feasibility and usability, the present study uses a rigorous study design to measure outcomes that are directly associated with the quality of delivered care.Trial registrationThe study was registered at the German Clinical Trials Register (No. DRKS00026659 registered Nov 03 2021. World Health Organization Trial Registration Data Set, https://trialsearch.who.int/Trial2.aspx? TrialID = DRKS00026659.

The effects of Digital Buddy programme on older adults’ mental well-being: study protocol for a multi-centre, cluster randomized controlled trial

IntroductionMental well-being is associated with many mental health symptoms, including depression and health-related quality of life. Digital divide could impact mental health, particularly during the COVID-19 pandemic. Information and communication technology (ICT)-based tools and interventions could effectively provide social support. Intergenerational mentoring between college students and older adults could promote eHealth literacy and self-efficacy, and it is advocated to bridge the digital divide for older adults. However, the effectiveness of an intervention which employs ICT-based tools and intergenerational mentoring strategies (i.e. Digital Buddy) on mental well-being is unclear.MethodsThis study will employ a multi-centre, cluster-randomized, two-parallel-group, noninferiority, controlled trial design with a 1:1 group allocation ratio. In the intervention group, a Digital Buddy (i.e. a young volunteer) is assigned to a group of older adults in a 1:10 ratio. A series of training sessions for a minimum of 23 h will be provided to the older adults by Digital Buddy, who will also follow through the intervention period with the older participants. The training contents include ICT and mental health care knowledge and skills. The whole intervention period will last for 6 months between 14 sessions. In the control group, participants will receive the usual care. The primary outcome measure is mental well-being. We aim to recruit 292 older participants. Generalized estimating equations (GEE) will be used to examine the effects of the intervention.Ethics and disseminationThis trial has been registered at ClinicalTrials.gov (NCT05553730) on 23 September 2022, https://clinicaltrials.gov/ct2/show/NCT05553730, and all items come from the World Health Organization Trial Registration Data Set. It has been approved by the Research Ethics Committee of Tung Wah College, Hong Kong (reference number: REC2022143). The findings will be disseminated in peer-reviewed journals and presented at international conferences relevant to the subject fields.

The COMFORT trial: a randomised control trial comparing group-based COMpassion-FOcussed therapy and breathing pattern ReTraining with treatment as usual on the psychological functioning of patients diagnosed with cancer recurrence during COVID

BackgroundA cancer diagnosis is a known precipitant of psychological distress, with fear of recurrence being a well-documented distressing consequence of cancer. Cancer recurrence often results in an additional psychological burden, which may exacerbate as a result of the COVID-19 pandemic.MethodsThis is a single-centre, prospective, randomised controlled trial. Patients identified as having experienced cancer recurrence since March 2020 (the onset of the COVID-19 pandemic in Ireland) will be screened for participation. Eligible, consenting candidates who score 4 or higher on the Distress Thermometer will be enrolled in the study. Participants will be randomly allocated to receive either a 6-week, group-based, online, compassion-focussed therapy and breathing pattern retraining intervention or the control arm. Those in the control arm will all be offered the group intervention after the 18-week study period. The primary outcome is the Distress Thermometer score at 18 weeks post-baseline though secondary outcomes will include measures of mood, traumatic distress and mental adjustment to cancer.DiscussionTo our knowledge, this protocol describes the first RCT which directly examines the effect of a group-based psychological intervention on Irish patients experiencing cancer recurrence in the context of COVID-19. The outcome of this trial is likely to be twofold: It will determine if the psychological intervention achieves its primary objective of distress amelioration 3 months post-intervention and to establish the feasibility of delivering this intervention in a virtual format.Trial registrationClinicalTrials.gov NCT05518591. Registered on 25 August 2022. All items from the World Health Organization Trial Registration Data set have been included.

The effect of mHealth-based exercise on Insulin Sensitivity for patients with Hepatocellular carcinoma and insulin resistance (mISH): protocol of a randomized controlled trial

BackgroundThe importance of insulin resistance is gaining increasing attention as it plays an important role in carcinogenesis in hepatocellular carcinoma (HCC). Although exercise is the most important intervention for lowering insulin resistance, it is not easy for HCC patients to maintain high compliance and do appropriate exercise. Mobile health (mHealth) with wearable devices can be the solution to carry out an adjusted and supervised exercise that can normalize insulin resistance in patients with HCC. We developed an HCC-specific application equipped with patient-centered exercise. In this paper, we present a randomized controlled trial protocol comparing an intervention group with a control group to determine whether mHealth-based exercise is effective in normalizing insulin sensitivity in HCC patients with insulin resistance after anticancer treatment.MethodsAn assessor unblinded open label randomized controlled trial (RCT) will be conducted for 80 participants with treatment-naïve or recurrent HCC who have received treatment and achieved complete response at the time of screening. They will be randomly assigned (1:1) to one of two groups: an intervention group (n = 40) and a control group (n = 40). The intervention group will carry out mHealth-based exercise for 6 months from baseline, whereas the control group will receive the usual follow-up care for the first 3 months and mHealth-based exercise for the next 3 months. Both groups will be assessed at baseline, 3 months, and 6 months from baseline. The primary outcome is the normalized rate of insulin resistance in each group at 3 months. Insulin resistance is estimated by calculating homeostatic model assessment for insulin resistance (HOMA-IR). The secondary outcomes are body composition, physical fitness level, physical activity, and quality of life at 3 months.DiscussionThis study is the first RCT to investigate the effect of mHealth-based home exercise with a wrist-wearable device on insulin sensitivity, physical fitness, and quality of life for HCC patients with insulin resistance. The result of this RCT will confirm not only safety and functional improvement but also biological effect when exercising using mHealth in HCC patients.Trial registrationClinicalTrials.gov NCT04649671. Registered on 2 December 2020. The World Health Organization Trial Registration Data Set is not registered.

Ultrasound-guided, continuous erector spinae plane (ESP) block in minimally invasive thoracic surgery—comparing programmed intermittent bolus (PIB) vs continuous infusion on quality of recovery and postoperative respiratory function: a double-blinded randomised controlled trial

BackgroundMinimally invasive thoracic surgery (MITS) has been shown to reduce postoperative pain and contribute to better postoperative quality of life as compared to open thoracic surgery (Bendixen et al., Lancet Oncol 17:836–44, 2016). However, it still causes significant post-operative pain. Regional anaesthesia techniques including fascial plane blocks such as the erector spinae plane block (ESP) have been shown to contribute to post-operative pain control after MITS (Finnerty et al., Br J Anaesth 125:802–10, 2020). Case reports relating to ESP catheters have described improved quality of pain relief using programmed intermittent boluses (PIB) instead of continuous infusion (Bendixen et al., Lancet Oncol 17:836–44, 2016). It is suggested that larger, repeated bolus dose may provide superior pain relief, possibly because of improved spread of the local anaesthetic medications (Ilfeld and Gabriel, Reg Anesth Pain Med 44:285–86, 2019). Evidence for improved spread of local anaesthetic may be found in one study which demonstrated that PIB increased the spread of local anaesthetic medication compared to continuous infusions for continuous paravertebral blocks, which are another type of regional anaesthesia technique for the chest wall (Hida et al., Reg Anesth Pain Med 44:326–32, 2019). Similarly, regarding labour epidural analgesia, the weight of evidence is in favour of PIB providing better pain relief compared with continuous infusion (Onuoha, Anesthesiol Clin 35:1–14, 2017).Since fascial plane blocks, such as ESP, rely on the spread of local anaesthetic medication between muscle layers of the chest wall, intermittent boluses may be particularly useful for this group of blocks. However, until recently, pumps capable of providing automated boluses in addition to patient-controlled boluses were not widely available. To best of our knowledge, there are no randomised controlled trials comparing continuous infusion versus intermittent bolus strategies for erector spinae plane block for MITS in terms of patient centred outcomes such as quality of recovery.MethodsThis trial will be a prospective, double-blinded, randomised controlled superiority trial. A total of 60 eligible patients will be randomly assigned to receive an intermittent bolus regime of local anaesthetic vs a continuous infusion of local anaesthetic. The medication will be delivered via an ultrasound-guided erector spinae plane block catheter which will be inserted by an anaesthesiologist while the patient is under general anaesthetic before their MITS surgery begins. The primary outcome being measured is the Quality of Recovery (QoR-15) score between the two groups 24 h after surgery. Secondary outcomes include respiratory testing of maximal inspiratory volume measured with a calibrated incentive spirometer, area under the curve for Verbal Rating Score for pain at rest and on deep inspiration versus time over 48 h, total opioid consumption over 48 h, QoR-15 score at 48 h and time to first mobilisation.DiscussionDespite surgical advancements in thoracic surgery, severe acute post-operative pain following MITS is still prevalent. This study will provide new knowledge and possible recommendations about the efficacy of programmed intermittent bolus regimen of local anaesthetic vs a continuous infusion of local anaesthetic via an ultrasound-guided erector spinae plane catheter for patients undergoing MITS.Trial registrationThis trial was pre-registered on ClinicalTrials.gov Identifier: NCT05181371. Registered on 6 January 2022. All item from the World Health Organization Trial Registration Data set have been included.

Quality assessment and its influencing factors of lung cancer clinical research registration: a cross-sectional analysis.

BackgroundA better understanding of the current features of lung cancer clinical research registration is important for improving registration quality and standardizing the registration. This study aimed to assess the registration quality of lung cancer studies on ClinicalTrials.gov and analyze the influencing factors.MethodsLung cancer clinical researches registered in the ClinicalTrials.gov database were searched on 7 July 2021. The characteristics of trials that registered up to 7 July 2021 were assessed. The quality of completed and terminated lung cancer studies from 1 July 2007 to 7 July 2020 was assessed using a modified version of the World Health Organization (WHO) Trial Registration Data Set (TRDS, V.1.3.1). Multivariate logistic regression analysis was also used to analyze the factors influencing study registration quality. An above-average registration quality score represented a high registration quality.ResultsA total of 6,448 clinical studies on lung cancer were used to summarise the registration characteristics. Most interventional studies were randomized (41.88%), single group (48.07%), and open-label (82.86%) studies, while most observational studies were cohort studies (59.08%). In total, 2,171 completed and terminated studies were assessed, with an average quality score (out of 54) of 36.76±5.69. None of the assessed studies had a 100% modified TRDS reporting rate, and missing summary results were the main factor affecting the quality scores. Multivariate logistic regression analyses showed that prospective registrations [adjusted odds ratio (aOR), 2.18; 95% confidence interval (CI), 1.79–2.65], multi-center studies (aOR, 1.73; 95% CI, 1.39–2.16), government-sponsored studies (aOR, 3.09; 95% CI, 1.48–6.42), and published studies (aOR, 1.43; 95% CI, 1.15–1.78) were more likely to be high quality research.ConclusionsTo improve the quality of registration, awareness of prospective registration should be further improved and government investment should be increased. At the same time, more efficient and extensive data sharing after completion of the studies should be actively promoted.

Obtaining patients’ medical history using a digital device prior to consultation in primary care: study protocol for a usability and validity study

BackgroundWith the help of digital tools patients’ medical histories can be collected quickly and transferred into their electronic medical records. This information can facilitate treatment planning, reduce documentation work, and improve care. However, it is still unclear whether the information collected from patients in this way is reliable. In this study, we assess the accuracy of the information collected by patients using an app for medical history taking by comparing it with the information collected in a face-to-face medical interview. We also study the app’s usability from the patients’ point of view and analysing usage data.MethodsWe developed a software application (app) for symptom-oriented medical history taking specialized for general practice. Medical history taking will take place involving patients with acute somatic or psychological complaints (1) using the app and (2) verbally with trained study staff. To assess the perceived usability, patients will complete a questionnaire for the System Usability Scale. We will collect sociodemographic data, information about media use and health literacy, and app usage data.DiscussionDigital tools offer the opportunity to improve patient care. However, it is not self-evident that the medical history taken by digital tools corresponds to the medical history that would be taken in an interview. If simply due to a design flaw patients answer questions about signs and symptoms that indicate possible serious underlying conditions ‘wrong’, this could have severe consequences. By additionally assessing the app’s usability as perceived by a diverse group of patients, potential weaknesses in content, design and navigation can be identified and subsequently improved. This is essential in order to ensure that the app meets the need of different groups of patients.Trial registration German Clinical Trials Register DRKS00026659, registered Nov 03 2021. World Health Organization Trial Registration Data Set, https://trialsearch.who.int/Trial2.aspx? TrialID = DRKS00026659.

The clinical effectiveness and cost-effectiveness of a ‘stepping into day treatment’ approach versus inpatient treatment as usual for anorexia nervosa in adult specialist eating disorder services (DAISIES trial): a study protocol of a randomised controlled multi-centre open-label parallel group non-inferiority trial

BackgroundAnorexia nervosa (AN) is a serious and disabling mental disorder with a high disease burden. In a proportion of cases, intensive hospital-based treatments, i.e. inpatient or day patient treatment, are required, with day patient treatment often being used as a ‘step-down’ treatment after a period of inpatient treatment. Demand for such treatment approaches has seen a sharp rise. Despite this, the relative merits of these approaches for patients, their families, and the NHS and wider society are relatively unknown. This paper describes the rationale for, and protocol of, a two-arm multi-centre open-label parallel group non-inferiority randomised controlled trial, evaluating the effectiveness and cost-effectiveness of these two intensive treatments for adults with severe AN: inpatient treatment as usual and a stepped care day patient approach (the combination of day patient treatment with the option of initial inpatient treatment for medical stabilisation). The main aim of this trial is to establish whether, in adults with severe AN, a stepped care day patient approach is non-inferior to inpatient treatment as usual in relation to improving body mass index (BMI) at 12 months post-randomisation.Methods386 patients with a Diagnostic and Statistical Manual 5th edition diagnosis of severe AN or related disorder, with a BMI of ≤16 kg/m2 and in need of intensive treatment will be randomly allocated to either inpatient treatment as usual or a stepped care day patient approach. Patients in both groups will receive treatment until they reach a healthy weight or get as close to this point as possible. Assessments will be conducted at baseline (prior to randomisation), and at 6 and 12 months post-randomisation, with additional monthly symptom monitoring. The primary outcome will be BMI at the 12-month post-randomisation assessment. Other outcomes will include psychosocial adjustment; treatment motivation, expectations and experiences; cost-effectiveness; and carer burden.DiscussionThe results of this study will provide a rigorous evaluation of two intensive treatment approaches which will inform future national and international treatment guidelines and service provision.Trial registrationISRCTN ISRCTN10166784. Registered 28 February 2020. ISRCTN is a primary registry of the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) network and includes all items from the WHO Trial Registration Data Set.

Reporting characteristics of allergic rhinitis trials registered on ClinicalTrials.gov and in publications: an observational study

Background: Data from randomized controlled trials (RCTs) on Allergic rhinitis (AR) should be complete and consistent throughout multiple sources to ensure accurate evidence-based information. The aim of this study was to determine whether there are discrepancies in the reported data from AR trials. Methods: This cross-sectional study retrospectively analyzed completed RCTs on AR registered in ClinicalTrials.gov and last updated between 9/27/2009 and 10/4/2019 with results and corresponding publications. Completeness, informativeness and major changes to World Health Organization Trial Registration Data Set items as well as completeness of results data in ClinicalTrials.gov and corresponding publications were analyzed. Results: Omitted items were present in 35 (46.1%) of the 76 trials at initial registration, 15 (19.7%) at last registration, and in 22 (56.4%) of the 39 publications. All 76 trials between first and last registration and all 39 publications had major changes in registration items. Uninformative reporting of analyzed items were present both in ClinicalTrials.gov and publications. Completeness of results in ClinicalTrials.gov was satisfactory. In contrast, publications reported fewer adverse events. Conclusions: Discrepancies in data elements of AR trials are common both in ClinicalTrials.gov and subsequent publications. To ensure transparent data reporting from AR trials, multiple stakeholders should control the accuracy, consistency, and completeness of AR trial data to notice discrepancies before publication.

Effect of “Mehrpishegan” web-based support group on depression, anxiety, and stress among elderly informal caregivers: a protocol for a randomized-controlled trial

BackgroundElderly population in low- and middle-income countries is rapidly growing, which indicates an increase in the number of dependent people needing long-term care. Caring for the elderly is difficult and stressful and threatens physical and mental health of informal caregivers. We aim to design a web-based support group and assess its effectiveness on depression, anxiety, and stress among elderly informal caregivers.MethodsThis is a protocol for a two-arm randomized controlled trial. A total of 160 informal elderly caregivers will be recruited from the southern area of Tehran. Eligible participants will be randomly allocated to two intervention and control groups. The inclusion criteria include not receiving salary for caring, having primary responsibility for care, having smartphone/tablet/computer, being able to use the contents and web applications, having at least one month of experience in caring for the elderly, and having access to the Internet at least once weekly. The intervention will be implemented by giving an account access to the designed website. Depression, anxiety, and stress will be assessed using the DASS21 questionnaire at baseline, and at the end of third and sixth months.DiscussionOur findings can pave the way for improving the mental health of informal caregivers of the elderly through provision of web-based supportive services. This study stands as an opportunity to address the needs of caregivers and help them support each other in a novel way.Trial registrationIran Randomized Clinical Trial Center IRCT20201012048999N1. Registered on 25 December 2020 (current status: ongoing).The World Health Organization Trial Registration Data Set is in Additional file 1Protocol versionSecond version 2021-05-27