Examining the effecting of a life-coaching intervention on breast cancer survivors’ post treatment adjustment: protocol of a parallel group randomized controlled trial

<p class="Default"><strong>Background:</strong> The growing number of breast cancer survivors in the country has warranted health interventions targeted to mitigate the bio-psychosocial impact associated with a cancer diagnosis and the toxicities of oncological treatments. Life coaching is a widely adopted intervention strategy to promote an individual’s positive psychological adaptation, self-management, and self-confidence. This present study will investigate whether a life coaching intervention with group and individual coaching components can significantly improve quality of life (QoL) and post traumatic growth among breast cancer survivors.</p><p class="Default"><strong>Methods: </strong>This study is a randomized controlled trial with three parallel study arms. A prospective sample size of 120 adult breast cancer survivors will be randomized into one of the three study groups either to receive: 1) group coaching following by individual coaching sessions; 2) group coaching sessions only; or 3) routine care. The primary outcome evaluates post traumatic growth and secondary outcomes assess QoL and fear of cancer recurrence (FCR). Data collection will occur at baseline (T0) and at 3 weeks (T1), and at 18 weeks (T2). A follow-up assessment will occur at 30 weeks (T3).</p><p class="Default"><strong>Conclusions: </strong>This is the first randomized control trial to address post traumatic growth among breast cancer survivors using a life coaching intervention. If positive, the results of this study could inform intervention development that benefits the health of cancer survivors.</p><p class="Default"><strong>Trial registration: </strong>This trial is ethically approved and registered with clinical trial registry (NCT05020561).</p>

Development and evaluation of a culturally tailored education module for type 1 diabetes in a resource-constrained setting: protocol for a mixed-methods study

<p class="abstract"><strong>Background:</strong> Diabetes education is the key to successful diabetes management. There is a need for an education module for type 1 diabetes (T1D) that is culture-specific and suited to resource constraints.</p><p class="abstract"><strong>Methods:</strong> A mixed-methods study will be conducted, in three phases, to develop and evaluate a culturally tailored diabetes education module for Indian children with T1D and their families. During the first phase, a qualitative study among health professionals and families of children with T1D for need assessment will be conducted. During the second phase, based on the themes from the last phase, an educational module will be developed. The third phase will involve an evaluation of the content, feasibility and effectiveness of the proposed module. The content evaluation will be done using the standardized 'suitability assessment of materials' checklist. For feasibility, a mixed-method approach will be used with iterative cycles of satisfaction scale, semi-structured interview and feasibility and observation checklist. The module will be revised after each cycle till no new changes are suggested. The effectiveness will be assessed by a quasi-experimental controlled trial assessing glycemic control, health-related quality of life, clinically important events and self-management practices in T1D children at baseline and three and six months.</p><p class="abstract"><strong>Conclusions: </strong>This study aims at development and validation of a novel culturally tailored diabetes education module for children with T1D, suited to their resource constraints. A module designed with the inputs from all stakeholders, and evaluated using iterative cycles, has the potential to suit the dynamic nature of diabetes management in children.</p><p class="abstract"><strong>Trial registration:</strong> Trial registration number is CTRI/2021/04/032739.</p>

Media recruitment in dementia research in a middle-income country

<span lang="EN-US">The inclusion of elderly people without dementia is essential for Alzheimer's disease research, both from the perspective of biomarkers development and for the potential therapy’s evaluation. Recruitment of individuals in the early stages of the pathological process of Alzheimer's disease is arguably difficult, especially regarding racial and ethnic minority groups.</span>

Internet-based cognitive behavioral therapy versus internet-based modified present-centered therapy for world trade center responders and survivors with posttraumatic stress disorder: rationale and design of a randomized controlled trial

<p><strong>Background:</strong> Nearly two decades following the 9/11/2001 world trade center (WTC) attacks, a substantial proportion of WTC rescue and recovery workers (“responders”) and WTC survivors continue to experience WTC-related posttraumatic stress disorder (PTSD) symptoms. Internet-based cognitive behavioral therapies (I-CBT) are short-term, evidence-based, scalable treatments with the potential to reach large numbers of symptomatic WTC workers and survivors. However, no I-CBT studies have been conducted in the WTC cohort.</p><p><strong>Methods:</strong> This report describes the rationale and design of an ongoing randomized controlled trial comparing integrative testimonial therapy (ITT), an I-CBT, to an active comparison treatment, internet-based modified present-centered therapy. The primary aim is to evaluate the efficacy of ITT in mitigating WTC-related PTSD symptoms in WTC responders and survivors with full or subthreshold WTC-related PTSD. The efficacy of ITT in reducing comorbid depressive and anxiety symptoms, and improving functioning, quality of life, and post-traumatic growth will additionally be evaluated. Saliva samples are also collected to explore genetic and epigenetic biomarkers of treatment response.</p><p><strong>Conclusions: </strong>This is the first I-CBT trial to compare ITT to a credible and active treatment, controlling for critical third-variable explanations of superiority (e.g., non-specific therapy effects). This RCT bridges an important research gap in the rising field of I-CBT interventions and adds to the literature on the design of trials investigating evidence-based treatments for PTSD in WTC- and other trauma-affected populations. </p><p><strong>Trial registration: </strong>This trial was registered on clinicalTrials.gov on May 16, 2017 (NCT03154151).</p>

Determination of maintenance Jarlsberg® cheese dose to keep the obtained serum osteocalcin level; a response surface pathway designed de-escalation dose study with individual starting values

<p class="abstract"><strong>Background:</strong> Daily maximum effective dose (MED) of Jarlsberg® increased the serum osteocalcin (tOC) level, vitamin K2 and affected the lipid pattern positively. The aim of the study was to estimate and verify a daily maintenance dose.</p><p class="abstract"><strong>Methods:</strong> 12 healthy female volunteers (HV) were included in a de-escalation study after a six week run-in period on the daily MED of 57 g Jarlsberg® cheese. A 3-level within-patient response surface pathway (RSP) design with individual starting values was developed. Another 12 HVs were included in a new study with a six week run-in period on MED followed with six weeks on the estimated maintenance dose. All HVs were premenopausal female between 20 and 52 years of age. The main variable in the studies was the tOC level.</p><p class="abstract"><strong>Results:</strong> tOC, cOC and the vitamin K2 variants increases significantly (p&lt;0.01) during the run-in period on daily MED of Jarlsberg® in both studies. The maintenance daily dose was estimated to 45 g (95% CI: 38-52 g/day) and used in the new study. The tOC level was reduced from 19.8 ng/ml (95% CI: 12.0-27.6) obtained in the run-in period to 18.5 ng/ml (95% CI: 11.7-25.3) during the maintenance part. This represents a reduction of 6.6%. The sum of vitamin K2 variants changed from 0.58 ng/ml on MED of Jarlsberg® to 0.59 ng/ml (95% CI: 0.37-0.82) during the maintenance period.</p><p class="abstract"><strong>Conclusions: </strong>Daily MED of Jarlsberg® cheese increases tOC, cOC and the vitamin K2 level. The maintenance Jarlsberg® dose was estimated to 45 g/day and verified as sufficient.</p>

Sample size calculation for Mann-Whitney U test with five methods

<p><strong>Background: </strong>Precise sample size estimation plays a vital role in the planning of a study specifically for medical treatment expenses that are expensive and studies that are of high risk.</p><p><strong>Methods: </strong>Among a variety of sample size calculation methods for the nonparametric Mann-Whitney U test, five potential methods are selected for evaluation in this article. The evaluation of method performance is based on the results obtained from high precision Monte Carlo simulations.</p><p><strong>Results: </strong>The sample size deviations (from the simulation ones) are performance indicators. The sum of the squared deviations over all scenarios is used as the criterion for ranking the five methods. For power comparisons, the percentage errors (relative to the simulated powers) are used. The effect size and target power both have large impacts on the minimum required sample sizes.</p><p><strong>Conclusions: </strong>Based on the ranking criterion, Shieh's method has the best performance. Noether's method always overestimates the minimum required sample sizes but not too severe.</p>

Clinical research education: a mini-review of the available opportunities for future and current clinical trial managers

<p class="abstract">Various for-profit as well as not-for-profit organizations offer educational opportunities for project managers. Often, these are generic (not industry-specific) as the goal is to attract a wide audience of students. Examples include Six Sigma and the Project Management Professional ® program. Although students may be granted an opportunity to research their own industry as part of the curriculum, these programs generally do not focus on clinical research project management skills in particular. Therefore, it can be difficult for Clinical study managers/clinical project managers, and others within the clinical research field, to find appropriate training opportunities. This aim of the study was to provide valuable information on some of the primary available educational opportunities that exist for those entering the clinical research management workforce, or who are otherwise interested in expanding their knowledge in this field.</p>

Psychometric properties of quantitative sensory testing focusing on healthy and patients with shoulder pain: a systematic review protocol

<p class="abstract"><strong>Background:</strong> Quantitative sensory testing (QST) is a battery of non-invasive psychophysical methods to assess the function of somatosensory system. Although the use of QST is widespread and several studies in patients with chronic shoulder pain have used it, the level of evidence for the psychometric properties has not been established. The aim of this protocol is to investigate, through a systematic review, the level of evidence for the psychometric properties of QST in the shoulder.</p><p class="abstract"><strong>Methods:</strong> For conducting and reporting this review the preferred reporting items for systematic reviews and meta-analysis (PRISMA) guidelines and the consensus-based standards for the selection of health measurement instruments (COSMIN) guidelines will be used. Nine databases including PubMed, Medline, AMED (via EBSCO), PEDRO, Embase, Web of Science, Scopus, SportDiscus, Google Scholar and Cochrane Library will be searched for the period from their inception until September 2021. Two reviewers (BP and SK) will independently evaluate the retrieved articles (titles and abstracts) and the psychometric characteristics checklist based on the standards from the COSMIN. The modified grading of recommendations assessment, development, and evaluation (GRADE) approach will be used to assess the overall quality of the evidence.</p><p class="abstract"><strong>Conclusions: </strong>Evaluation of the level of evidence for the psychometric properties of QST in the shoulder is an essential step for evidence-based assessment in clinical practice.</p><p class="abstract"><strong>Trial registration:</strong> PROSPERO registration number is CRD42021232778.</p>

Rationale, study design and methodology of the hypertension registry: a Pan-India, prospective, longitudinal study to assess management and real-world outcomes of high-risk essential hypertension

<p class="abstract"><strong>Background:</strong> India contributes significantly towards a large part of the worldwide epidemic of hypertension (HTN) and its associated complications. As, there are limited longitudinal studies available in India to understand its occurrence over time, this Pan-India longitudinal study will aid to assess the real world outcomes of HTN across the country.</p><p class="abstract"><strong>Methods:</strong> This was a prospective, multi-centered, longitudinal, observational study investigating a large COHORT of people with HTN across India over a period of one year. The primary objective of this study was to evaluate blood pressure (BP) control and clinical outcomes in high-risk hypertensive patients distributed over 5 visits (including baseline visit). The secondary objective is to assess the co-morbidities/risk factors in different clinical settings across India. Participants (4,000) with HTN will be included from 200 centres across India and data will be recorded for the use of anti-hypertensives, demographics, socio-economic status, anthropometric measurements, family history, personal history, risk factors, co-morbid conditions and physician treatment preferences. Overall, clinical practice patterns were assessed for their relationship with clinical outcomes.</p><p class="abstract"><strong>Conclusions: </strong>This study is expected to reveal the trends in complications associated with HTN, treatment strategies used by physicians, and correlation among treatment, control and complications of HTN within the Indian context. The outcome of this study will help to identify the burden of HTN, along with pin-pointing the emergence of early-onset complications and dose titration patterns. This will eventually help to develop person-centred care and facilitate public health agencies to invest appropriate resources in the management of high-risk HTN across India.</p><p class="abstract"><strong>Trial registration:</strong> Since this is a real world evidence study no trial registration was needed as per Indian regulations.</p>

Trial design and protocol of randomized controlled trial comparing the efficacy of oral mefenamic acid, paracetamol and placebo for analgesic prophylaxis in childhood vaccination (MAP VaC trial)

<p class="abstract"><strong>Background:</strong> Needle related pain has been one of the most important concerns for parents of children receiving vaccination. Non-steroidal anti-inflammatory drugs (NSAIDs) like paracetamol and mefenamic acid have been commonly used as analgesics in pediatric population. However, prophylactic administration of these drugs for analgesia during vaccination has not been studied. The main objective of this study is to compare the efficacy of prophylactic paracetamol, mefenamic acid and placebo on needle pain associated with vaccination.</p><p class="abstract"><strong>Methods:</strong> This is a three-arm parallel, triple blind, randomized controlled trial. Children aged 6 weeks to 7 years who need immunization as per national immunization schedule and reporting to pediatric outpatient department (OPD) at tertiary level hospital, AIIMS Mangalagiri, Andhra Pradesh, will be included. All participants will be randomly allotted to any of the three groups by computer based block randomization. Each participant will be given any one of the three drugs as per their allocation. Vaccination will be done as per national immunization schedule after 30 minutes of drug administration. Face, legs, activity, cry, consolability (FLACC) scoring will be done immediately after vaccine administration and repeated at 15 minutes and 30 minutes. All personnel involved in randomization, drug and vaccine administration, FLACC scoring and statistical analysis will be blinded along with parents and children enrolled in the study.</p><p class="abstract"><strong>Conclusions: </strong>If this intervention study shows evidence of a difference between drug and placebo signifying reduction in vaccine related pain with these drugs, this will have a huge impact on National Immunization programme by improving compliance, vaccine coverage and by reducing vaccine hesitancy.</p><p class="abstract"><strong>Trial registration:</strong> Clinical trials registration number is CTRI/2021/01/030239.</p>