International Journal of Clinical Trials

Effectiveness of online psychological intervention for caregivers on the quality of life of people with Alzheimer disease: a randomized clinical trial protocol

Jordina Muñoz-Padros — 2023-07-26

Background: Alzheimer's disease (AD) has a significant impact on the quality of life (QOL) and interventions aimed at their improvement show inconclusive results. Objectives were study protocol to evaluate the effectiveness of a multicomponent caregiver intervention on the QOL of persons with AD.

Methods: The design is a randomized clinical trial with blinded assessment of response variables. Ninety-four dyads of informal caregivers and their relatives with AD will be recruited in the Osona and Ripollès territorial service of geriatrics and palliative care of the Consorci Hospitalari de Vic (Osona, Spain) and randomized into experimental (EG) and control group (CG). An 8-week online multicomponent psychological intervention including psychoeducation and mindfulness will be provided to the EG caregivers. The CG will perform the usual care. Outcome will be the QOL of persons with AD assessed with the QOL-AD.

Conclusions: The multicomponent online caregiver research detailed in this protocol could be incorporated into health and care facilities for persons with AD and their families to improve caregiving and QOL.

Protocol of randomized controlled trial comparing T piece resuscitator versus self-inflating bag for resuscitation in the delivery room in preterm neonates

Harshit Kumar — 2023-07-26

Background: Neonatal resuscitation is a critical process for a newborn with effective ventilation as its key component. Three manual ventilation devices, including self-inflating bags (SIB), flow-inflating bags (FIB), and T-piece resuscitator (TPR) are recommended for positive pressure ventilation (PPV) in the delivery room. To date, there is insufficient evidence regarding the optimal device for establishing effective ventilation in newborns. This study is planned to compare the effectiveness of TPR and SIB during resuscitation.

Methods: This will be a single centre, open-label, randomized controlled trial. Study participants will be preterm ≤34 of gestation needing PPV at birth as per NRP algorithm. Newborns will be randomly assigned to two groups (TPR or SIB). SpO₂ at 2 and 5 min, time to reach heart rate >100/min by pulse oximetry, and duration of PPV will be recorded. Primary outcome is need of delivery room intubation. Intention to treat analysis will be done using STATA version 17.0. A priori defined subgroup for purpose of analysis will be gestation ≤30 and 31-34 weeks. Trial will be done as per good clinical practice guidelines.

Conclusions: If PPV with TPR is proven to be more efficacious in terms of less delivery room intubation, there would be a way towards finalizing the TPR as primary device for providing PPV during delivery room resuscitation at birth. This study has potential to bring down need of delivery room intubation with less duration of mechanical ventilation and morbidity in form of IVH, BPD and composite outcome of BPD and death.

Trial registration: CTRI number: CTRI/2023/01/048660.

Identifying predictive factors and developing evidence-based guidelines for promoting respectful maternal and newborn care: a mixed method multiphase study design

Sharmila Vijayan — 2023-07-26

Background: Mistreatment of women during pregnancy and childbirth by healthcare workers is a common issue in both private and public sector health facilities in India. Improving the quality of maternity care in these sectors is crucial for promoting institutional births and ensuring positive birth experiences. This study aims to develop guidelines for respectful maternity care (RMC) in India through a multiphase quantitative and qualitative study.

Methods: The study will utilize a mixed methods multiphase design, which involves collecting, analyzing, and integrating both quantitative and qualitative data. This approach follows the principles of pragmatism paradigm, where the integration of different approaches enhances understanding. The quantitative data will be used to expand and explain the qualitative data collected in the first phase. The integration of both types of data will contribute to the development of new RMC guidelines.

Conclusions: This study is the first of its kind in India to develop comprehensive RMC guidelines based on a multiphase study. By exploring the experiences of Indian women regarding disrespect and abuse (D&A) during childbirth and its determinants, the study will provide valuable insights for guideline development. The integration of quantitative and qualitative approaches in the mixed method design will address potential limitations and provide a more comprehensive understanding of the subject.

Effect of iron folic acid with tablet vitamin C compared to iron folic acid with routine verbal advice of vitamin C rich foods on the hemoglobin levels of anemic pregnant women attending a tertiary care hospital in Puducherry: protocol for a pragmatic trial

Alyssa M. Prince — 2023-07-26

Background: In routine practice, pregnant women are advised to take iron folic acid (IFA) tablets with vitamin C-rich foods. If vitamin C tablets are given instead, there may be an improvement in the hemoglobin levels of pregnant women. The study aims to find the effectiveness of IFA tablet with vitamin C tablet compared to IFA tablet with verbal advice of vitamin C rich foods, over 6 weeks, on the hemoglobin levels of anemic pregnant women (13-33 weeks) attending a tertiary care hospital in Puducherry.

Methods: A pragmatic trial will be conducted in the antenatal OPD of a hospital in Puducherry. Anemic pregnant women will be consecutively recruited until a sample size of 86 is attained. Permuted block randomization and allocation concealment will be used. After eligibility assessment, participants will be randomly assigned two arms. The intervention arm will receive IFA tablets with vitamin C tablets, while the control arm will be advised to take IFA tablets with vitamin C-rich food. Participants will be followed up at 6 weeks. The intention-to-treat approach will be used. Linear regression will be performed followed by multivariable linear regression to adjust for confounding variables.

Conclusions: This study protocol is designed to investigate whether the hemoglobin status and control of anemia in anemic mothers can be improved by giving IFA tablets with vitamin C tablets in routine practice, rather than verbal advice to take IFA tablets with vitamin C-rich foods.

Can definitive chemoradiation offer a cure along with cosmesis in locally advanced IVA carcinoma buccal mucosa? a case report

Jyoti Sharma — 2023-07-26

Surgery is the mainstay of the treatment in ca buccal mucosa. It is extensive in nature and may require efficient reconstruction for good cosmetic outcome. Adjuvant radiation or chemo-radiation may be needed in advanced cancers. Definitive chemoradiation or palliative radiation are reserved for inoperable patients. We present a case report of advanced carcinoma of oral cavity in the left buccal mucosa along with involvement of retromolar trigone along with bone involvement in left sided mandible who opted out for undergoing definitive surgery. She was treated with definitive chemoradiation with 2.4 Gy per day /0.4 Gy in morning, 2 Gy in evening five days a week along with paclitaxel on Sunday. Patient reported after seven years disease free with excellent cosmetic outcome. Definitive surgery along with adjuvant radiation or chemoradiation is the standard of care in advanced cancers of buccal mucosa. However, in inoperable patients or the patients refusing surgery definitive chemoradiation with altered fractionation schedules may still offer a chance of cure and good cosmesis.

How big is a big hazard ratio in clinical trials?

Yuanyuan Lu — 2023-07-26

Background: The hazard ratio has been widely used as an index of effect size in clinical trials for time-to-event data. The use of the Cox proportional hazards models and other hazard centered models is ubiquitous in clinical trials for time-to-event data. The relativity of effect sizes (small, medium, large) has been widely discussed and accepted when comparing magnitude of association for continuous and categorical data, but not yet for time-to-event outcomes.

Methods: We review published hazard ratios, investigate the relationships among HR, relative risk (RR), odds ratio (OR), and Cohen’s d, and calculate the corresponding HRs for given event rate in control group ( ) by adding standard normal deviation with 0.2 (small), 0.5 (medium) and 0.8 (large) to the event rate in the case group ( based on equation .

Results: Our results indicate that HRs are from 1.68 to 1.16 when the event rate of control group moves from 1% to 90%, which are equivalent to Cohen’s d = 0.2 (small). HRs are ranged between 3.43 and 1.43 when the event rate of control group moves from 1% to 90%, which are equivalent to Cohen’s d = 0.5 (medium), HRs are valued between 6.52 and 1.73 when the event rate of control group moves from 1% to 90%, which are equivalent to Cohen’s d = 0.8 (large).

Conclusions: This study provides general guidelines in interpreting the magnitudes of HRs for time-to-event data in clinical trials.

The value of clinical trial medication and yearly medicine cost avoidance from clinical trials conducted by the pharmaceutical industry in Finland

Mia Marina Bengtström — 2023-07-26

Background: Clinical trials have been reported to cause medication cost avoidance (MCA) for hospitals and societies, but there are no studies documenting MCA from the Nordic countries or from the pharmaceutical industry perspective.

Methods: Three different methods were tested for determining the yearly MCA in clinical trials conducted by the pharmaceutical industry in Finland. MCA was evaluated with questionnaires to pharmaceutical companies operating in Finland in 2001, 2009 and 2013.

Results: In method 1 (year 2001), the MCA in Finland was 70.3 million euros in wholesale price and 50.9 million euros when excluding patients receiving placebo treatment. In method 2 (2009), the MCA was 52.0 million euros in wholesale price and 71.0 million euros in out-sale price i.e. including pharmacy fee and tax. The MCA in method 3 (2013) was 47.2 million euros in wholesale price. The collection of data and the MCA calculation was simple in method 1 (response rate 100%). The methods 2 and 3 were more precise but more time-consuming for the respondents, somewhat affecting the response rate (response rates 90% and 72%, respectively).

Conclusions: All three methods covered the majority of industry-sponsored clinical medicine trials (64-100%) representing 59-63 % of all clinical trials conducted in Finland in those years. Regardless of the methods, the study medications provided by the pharmaceutical industry promoted significant cost saving for the society. We recommend method 1 for a general and less time consuming MCA calculation and method 3 for a more precise calculation, to be conducted in survey format and interview.

Cross sectional study to evaluate modified Alvardo score in the diagnosis of acute appendicitis

Pramatha Nath Dutta — 2023-05-05

Background: Appendectomy is one of the most commonly performed emergency operation. The diagnosis requires distinguishing from other causes of pain in that region of the abdomen like acute ureteric colic, right sided salphingoophoritis. Presently ultrasonogram and contrast enhanced CT scan are the diagnostic modalities of choice. Although these facilities are readily available in urban areas but rural areas still suffer from lack of timely diagnosis and negative appendectomy, enhancing the need for a reliable scoring system for diagnosis of acute appendicitis. Here we will evaluate modified Alvardo scoring system in diagnosis of acute appendicitis.

Methods: This is an observational cross-sectional hospital-based study at KPC medical college, Kolkata with 92 consecutive cases of suspected acute appendicitis, who were admitted, investigated and treated during 1st February 2022 to 31^st January, 2023. Modified Alvardo score is calculated of each patient and compared with the histopathological findings of operated appendix.

Results: The above study shows that modified Alvardo score 7-9 has high sensitivity of 93.10% in men and in female sensitivity is 77.78%. Overall sensitivity of modified Alvardo score of 7-9 came out to be 83.63%.

Conclusions: It can be concluded that modified Alvardo score of 7-9 can be used as a potent diagnostic tool in male. But in females due to lower sensitivity and significant number of negative appendectomy, it can be used an diagnostic aid in addition to imaging studies for diagnosis.

Evaluate the effectiveness of hydrotherapy versus land-based exercises outcome on pain and quality of life among patients with rheumatoid arthritis: triple-blind randomized controlled trial

Rajendra Kumar Jinjwaria — 2023-07-26

Background: Evaluate the effectiveness of hydrotherapy versus land-based exercise outcomes to decrease pain and improve the quality of life among patients with rheumatoid arthritis.

Methods: Triple-blind, randomized controlled, parallel-group, multiple arm trial was conducted between 29/09/2019 to 30/09/2021 at the Department of PMR, KG University Lucknow India and randomization was done through the SNSOE. Eligible 90 patients suffering from rheumatoid arthritis. The intervention (RJHLERA) was administered in both study groups. NRPS used for pain and RJQOL-22 Scale was used for QoL.

Results: The pre-test results showed all the subject’s average pain scores and quality of life had either poor or neither poor nor good levels of the RJQOL-22 scale. At the post-test, in terms of pain, the hydrotherapy exercise group showed the maximum response with an average pain score of 3.64±1.89, the land-based exercises group showed the next to maximum response with an average pain score of 5.88±1.37 while the control group showed the least response with an average pain score of 7.63±1.41. and in terms of quality of life, the hydrotherapy exercise group showed the maximum response with 67.9% very good, and 21.4% good. The land-based exercises group showed the next to maximum response with 19.2% good while the group the clear control group showed the least response.

Conclusions: Effectiveness of hydrotherapy versus land-based exercises, in comparison to land-based exercises the Hydrotherapy exercises group showed the maximum response to reduce the pain and improve the quality of life among chronic rheumatoid arthritis patients.

Epidemiology, clinical profile and outcome of acute kidney injury in intensive coronary care unit

Sharanabasappa . — 2023-07-26

Background: The incidence of AKI in cardiac ICU is attributed mainly to Heart Failure and Acute Coronary Syndrome. AKI occurs commonly in the setting of AHF, and is termed CRS type 1. Biomarkers and bioelectrical impedance analysis can be helpful in estimating the real volume overload and may be useful to predict and avoid AKI. The role of UF remains controversial, and it is currently recommended only for diuretic-resistant patients. Objective of current study was to study demographic & clinical profile and outcome of patients with AKI in intensive coronary care unit.

Methods: This prospective study was conducted in ICCU of R.N.T. Medical College, Udaipur. All the patients with increase in serum creatinine >50% were included in the study. Detailed investigations like urinary analysis, renal function tests (blood urea, serum creatinine, serum electrolytes), USG whole abdomen, 12 lead ECG, Echocardiography and Troponin T.

Results: Among cases 56.67% had ADHF, 25% had MI, 10% had structural heart disease, 3.3% had systemic illness, 1.67% had cardiogenic shock, 1.67% were cardiac surgery associated and 1.67% had other causes of AKI. 30.0% of cases required ionotropic support while 2.5% of controls required ionotropic support. 5.0% of cases required ventilator support & renal replacement therapy while none of the controls required these.

Conclusions: Patients with AKI had worse outcomes when compared to non-AKI. Mortality among cases was significantly higher than controls, 10% among cases versus only 2.5% in controls.

Clinical trial designs: a simplified overview

Pranali M. Wandile — 2023-07-11

Clinical trials aim to invent new, better, safer, more effective ways to prevent, detect, or treat health conditions and to compare them to existing standards of care as applicable. This scientific inquiry prompts researchers to design and develop proposed clinical trial protocols to evaluate preliminary information about the product and develop research questions and objectives. The average budget for new product development is enormous, and this eventuality is because almost 90 percent of a trial drugs never get approved. Hence, having an appropriate clinical trial design is crucial for successful product development. A trial's ability to deliver the proposed indication relies on its suitable design, background information, the trial justification to sample size, interim monitoring rules, and ways to review and analyze study data. In this article, we presented an overview of clinical trial designs emphasizing adaptive designs in a simplified way for field-based clinical research professionals.

The understanding of epidemiology and study designs

Pranali Wandile — 2023-07-26

The goal of health care systems is to keep patients healthy by monitoring, diagnosing, and treating their illnesses. These complex systems have many objectives, such as improving the quality of health care, making healthcare accessible to all people who are in need, extending people’s life span, preventing illnesses, etc. Promoting healthy lifestyles along with the prevention of illnesses to improve people’s health is also a fundamental principle of public health, and now it also become a fundamental principle of health care and integrating into health and social care strategies across the world. Epidemiology is the system of ultimate reasoning focused on creating and examining theories in systematic fields such as biology, physics, behavioral sciences. Epidemiology rationalize the health-associated states and events and provide the justification for further suitable real-world public health measures. While working in the field, I observed that allied healthcare professionals lacked basic knowledge about epidemiology and related study designs. The input from this healthcare professional not only assists in building meaningful research studies but also demonstrates its powerful impact on patients’ healthcare through preventive measures and study results. The goal of this article is to provide basic knowledge of epidemiology and its various study designs in a simplistic language to allied healthcare professionals working in the field. In this article, I have described a general overview of epidemiology and various study designs, along with examples. I hope this information could be beneficial for a better understanding of epidemiology to healthcare professionals working in the field.

Lessons learned from principal investigators on recruitment for community-based health behaviour studies during the COVID-19 pandemic

Rebecca A. Seguin-Fowler — 2023-07-26

Little is known about pandemic-related impacts on participant recruitment into community-based health studies during the COVID-19 pandemic. The aim of this report was to summarize lessons learned from principal investigators (PIs) of NIH-funded community-based health behavior studies that were scheduled to recruit during the COVID-19 pandemic. We report on findings from three open-ended questions that were part of a 50-question online survey conducted from December 2022 – January 2023, completed by 52 PIs. Four categories of lessons emerged to optimize recruitment into studies: formalize relationships with community partnerships; focus on study operations; recruitment is a science and an art; and reduce participant burden and increase participant benefit. Taken together, these recommendations will require longer and more complex recruitment plans. To implement these plans, researchers and funders will need to allocate more time, thoughtful attention, and financial resources to support formal community partnerships, additional staff time and training, real-time monitoring and refinement of multiple strategies throughout recruitment, and increased attention to participant benefit.

Rajendra Jinjwaria quality of life-22 scale (RJQOL-22) scale

Rajendra Kumar Jinjwaria — 2023-07-26

The Rajendra Jinjwaria quality of life-22 (RJQOL-22) scale will help assess the overall quality of life in various acute and chronic diseases such as rheumatoid arthritis, osteo arthritis, and other conditions that affect the quality of life such as cardiovascular, HIV, and cancer. The tool was developed from 29 January 2019 to 01 May 2023 by Rajendra Kumar Jinjwaria at King George's Medical University Lucknow and Banaras Hindu University, Uttar Pradesh, India. The validity of the RJQOL-22 scale was established as per the content validity index (CVI) 98% and validated by more than 100 expert faculty across the world. The scale is standardized and highly valid for assessing the quality of life in acute and chronic diseases. The overall reliability of the scale based on a study was estimated to be (>0.983) through (Cronbach’s alpha value) and it indicates a highly reliable scale. While the individual reliability of group I and group II was 0.989 and 0.978 respectively. The acceptable cut-off value of coefficients was 0.7 for moderate and 0.8 for high reliability. This indicates that the tool used in the studies was highly reliable.

Improving the quality of Greek web surveys: adaptation of the checklist for reporting results of internet e-surveys in Greek language

K. Vassis — 2023-07-26

The use of the internet for surveys and research is becoming increasingly widespread, including in observational research, which employs questionnaires and surveys to study various characteristics in patients, professionals, and institutions in biomedical and primary care research