scholarly journals Ten Rules for Conducting Retrospective Pharmacoepidemiological Analyses: Example COVID-19 Study

2021 ◽  
Vol 12 ◽  
Author(s):  
Michael Powell ◽  
Allison Koenecke ◽  
James Brian Byrd ◽  
Akihiko Nishimura ◽  
Maximilian F. Konig ◽  
...  
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Control Treatment ◽  
Medical Specialties ◽  
Health Care Data ◽  
Randomized Controlled ◽  
Use Of Time ◽  
Efficiency And Effectiveness ◽  
Treatment Administration

Since the beginning of the COVID-19 pandemic, pharmaceutical treatment hypotheses have abounded, each requiring careful evaluation. A randomized controlled trial generally provides the most credible evaluation of a treatment, but the efficiency and effectiveness of the trial depend on the existing evidence supporting the treatment. The researcher must therefore compile a body of evidence justifying the use of time and resources to further investigate a treatment hypothesis in a trial. An observational study can provide this evidence, but the lack of randomized exposure and the researcher’s inability to control treatment administration and data collection introduce significant challenges. A proper analysis of observational health care data thus requires contributions from experts in a diverse set of topics ranging from epidemiology and causal analysis to relevant medical specialties and data sources. Here we summarize these contributions as 10 rules that serve as an end-to-end introduction to retrospective pharmacoepidemiological analyses of observational health care data using a running example of a hypothetical COVID-19 study. A detailed supplement presents a practical how-to guide for following each rule. When carefully designed and properly executed, a retrospective pharmacoepidemiological analysis framed around these rules will inform the decisions of whether and how to investigate a treatment hypothesis in a randomized controlled trial. This work has important implications for any future pandemic by prescribing what we can and should do while the world waits for global vaccine distribution.

scholarly journals A how-to guide for conducting retrospective analyses: example COVID-19 study

2020 ◽  
Author(s):  
Michael Powell ◽  
Allison Koenecke ◽  
James Brian Byrd ◽  
Akihiko Nishimura ◽  
Maximilian F. Konig ◽  
...  
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Specific Treatment ◽  
Control Treatment ◽  
Practical Implementation ◽  
Medical Specialties ◽  
Health Care Data ◽  
Randomized Controlled ◽  
Use Of Time

In the urgent setting of the COVID-19 pandemic, treatment hypotheses abound, each of which requires careful evaluation. A randomized controlled trial generally provides the strongest possible evaluation of a treatment, but the efficiency and effectiveness of the trial depend on the existing evidence supporting the treatment. The researcher must therefore compile a body of evidence justifying the use of time and resources to further investigate a treatment hypothesis in a trial. An observational study can help provide this evidence, but the lack of randomized exposure and the researcher’s inability to control treatment administration and data collection introduce significant challenges for nonexperimental studies. A proper analysis of observational health care data thus requires an extensive background in a diverse set of topics ranging from epidemiology and causal analysis to relevant medical specialties and data sources. Here we provide 10 rules that serve as an end-to-end introduction to retrospective analyses of observational health care data. A running example of a COVID-19 study presents a practical implementation of each rule in the context of a specific treatment hypothesis. When carefully designed and properly executed, a retrospective analysis framed around these rules will inform the decisions of whether and how to investigate a treatment hypothesis in a randomized controlled trial.

scholarly journals Japanese health and safety information for overseas visitors: protocol for a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mariko Nishikawa ◽  
Masaaki Yamanaka ◽  
Akira Shibanuma ◽  
Junko Kiriya ◽  
Masamine Jimba
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Safety Information ◽  
Intervention Group ◽  
Health And Safety ◽  
Trial Registration ◽  
Control Group ◽  
Internet Portal ◽  
Randomized Controlled

Abstract Background Before the COVID-19 pandemic occurred in January 2020, the number of overseas visitors to Japan had increased threefold over the last decade. To minimize the risk of health problems, visitors should be able to access information on the health care systems of the places they visit. Most short-term overseas visitors are young adults. Although they are not very likely to get sick from noncommunicable diseases, they are at high risk for injury and often experience stomach ailments, fever, or nausea when travelling. The objective of this study is to evaluate culturally and linguistically appropriate health information on preventive health behaviours and the health care system in Japan. We will examine the level of satisfaction of overseas visitors to Japan with health care-related educational materials using a five-minute digital game named Sa-Chan Japan. Methods Our study is a randomized controlled trial (RCT). We will assess both satisfaction and motivation before, during, and after the interventions and examine the changes over time. The intervention group will comprise overseas visitors who will view and answer questions in an animation named Sa-Chan Japan. The control group will comprise overseas visitors who will watch an English digital animation named Mari Info Japan. We will recruit 1002 participants through the Macromill Internet portal. We will contact overseas visitors who have either visited or wish to visit Japan from the United Kingdom, United States, and Australia. The participants will fill out a self-administered questionnaire online in the first quarter of 2021. We will determine the participants’ levels of satisfaction with the CSQ-8 (8-item Client Satisfaction Questionnaire). We will analyse the median score of the overseas visitors with both the Wilcoxon rank-sum and the Wilcoxon signed-rank tests. Our protocol of randomized controlled trials follows the SPIRIT guidelines. Discussion Our research will utilize unique digital education strategies in a game that promotes health and safety among overseas visitors to Japan. We believe the results of this study will be useful in overcoming the current challenges regarding pretravel health requirements for overseas visitors worldwide. Trial registration Version 1 of this trial was registered in the UMIN-CTR (University Hospital Medical Information Network Center Clinical Trials Registry), and the trial registration data are available on UMIN000042483, November 17, 2020.

scholarly journals Effect of specialized bathing systems on resident cleanliness and water quality in nursing homes: a randomized controlled trial

2007 ◽  
Vol 5 (2) ◽  
pp. 283-294 ◽  
Author(s):  
Philip D. Sloane ◽  
Lauren W. Cohen ◽  
Christianna S. Williams ◽  
Jean Munn ◽  
John S. Preisser ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Bacterial Colonization ◽  
Controlled Trial ◽  
Nursing Home Residents ◽  
Skin Condition ◽  
Microbial Flora ◽  
Control Treatment ◽  
Staff Satisfaction ◽  
Randomized Controlled ◽  
The Impact

A randomized controlled trial evaluated the impact of different methods of water agitation on clinical and microbiological outcomes in 31 nursing home residents. Four conditions were tested: a) whirlpool tub, jets on, using standard soap products; b) ultrasound tub, ultrasound on, using the standard soap products; c) ultrasound tub, ultrasound on, using specialized soap and skin conditioner; and d) either tub (randomized), water circulation off, using standard soap products (the control condition). Outcomes of interest included skin microbial flora, water microbial flora, skin condition, time spent bathing, and staff satisfaction. Resident skin condition and skin microbial flora did not differ between the four treatments. The tubs also did not differ in terms of bacterial colonization; however, there was a non-statistically significant trend for the highest counts to occur in whirlpool tubs after being idle overnight. The ultrasound and whirlpool tubs were preferred by staff over the control treatment (still water) in terms of sound and overall suitability. In addition, staff reported that the ultrasound tub using enhanced skin cleansers made bathing residents easier and faster than the same tub using standard cleansers.

scholarly journals Group versus individual antenatal and first year postpartum care: Study protocol for a multi-country cluster randomized controlled trial in Kenya and Nigeria

2019 ◽  
Vol 2 ◽  
pp. 56 ◽  
Author(s):  
Mark M. Kabue ◽  
Lindsay Grenier ◽  
Stephanie Suhowatsky ◽  
Jaiyeola Oyetunji ◽  
Emmanuel Ugwa ◽  
...  
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Data Collection ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Phase 1 ◽  
First Year ◽  
Phase 2 ◽  
Randomized Controlled ◽  
Cluster Randomized

Background: Antenatal care (ANC) in many low- and middle-income countries is under-utilized and of sub-optimal quality. Group ANC (G-ANC) is an intervention designed to improve the experience and provision of ANC for groups of women (cohorts) at similar stages of pregnancy. Methods: A two-arm, two-phase, cluster randomized controlled trial (cRCT) (non-blinded) is being conducted in Kenya and Nigeria. Public health facilities were matched and randomized to either standard individual ANC (control) or G-ANC (intervention) prior to enrollment. Participants include pregnant women attending first ANC at gestational age <24 weeks, health care providers, and sub-national health managers. Enrollment ended in June 2017 for both countries. In the intervention arm, pregnant women are assigned to cohorts at first ANC visit and receive subsequent care together during five meetings facilitated by a health care provider (Phase 1). After birth, the same cohorts meet four times over 12 months with their babies (Phase 2). Data collection was performed through surveys, clinical data extraction, focus group discussions, and in-depth interviews. Phase 1 data collection ended in January 2018 and Phase 2 concludes in November 2018. Intention-to-treat analysis will be used to evaluate primary outcomes for Phases 1 and 2: health facility delivery and use of a modern method of family planning at 12 months postpartum, respectively. Data analysis and reporting of results will be consistent with norms for cRCTs. General estimating equation models that account for clustering will be employed for primary outcome analyzes. Results: Overall 1,075 and 1,013 pregnant women were enrolled in Nigeria and Kenya, respectively. Final study results will be available in February 2019. Conclusions: This is the first cRCT on G-ANC in Africa. It is among the first to examine the effects of continuing group care through the first year postpartum. Registration: Pan African Clinical Trials Registry PACTR201706002254227 May 02, 2017

scholarly journals Smartphone Cardiac Rehabilitation, Assisted Self-Management Versus Usual Care: Protocol for a Multicenter Randomized Controlled Trial to Compare Effects and Costs Among People With Coronary Heart Disease (Preprint)

2019 ◽  
Author(s):  
Jonathan Charles Rawstorn ◽  
Kylie Ball ◽  
Brian Oldenburg ◽  
Clara K Chow ◽  
Sarah A McNaughton ◽  
...  
Keyword(s):  
Health Care ◽  
Coronary Heart Disease ◽  
Randomized Controlled Trial ◽  
Cardiac Rehabilitation ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Management ◽  
Evidence Based ◽  
Randomized Controlled ◽  
Delivery Models

BACKGROUND Alternative evidence-based cardiac rehabilitation (CR) delivery models that overcome significant barriers to access and delivery are needed to address persistent low utilization. Models utilizing contemporary digital technologies could significantly improve reach and fidelity as complementary alternatives to traditional center-based programs. OBJECTIVE The aim of this study is to compare the effects and costs of the innovative <i>Smartphone Cardiac Rehabilitation, Assisted self-Management</i> (SCRAM) intervention with usual care CR. METHODS In this investigator-, assessor-, and statistician-blinded parallel 2-arm randomized controlled trial, 220 adults (18+ years) with coronary heart disease are being recruited from 3 hospitals in metropolitan and regional Victoria, Australia. Participants are randomized (1:1) to receive advice to engage with usual care CR or the SCRAM intervention. SCRAM is a 24-week dual-phase intervention that includes 12 weeks of real-time remote exercise supervision and coaching from exercise physiologists, which is followed by 12 weeks of data-driven nonreal-time remote coaching via telephone. Both intervention phases include evidence- and theory-based multifactorial behavior change support delivered via smartphone push notifications. Outcomes assessed at baseline, 12 weeks, and 24 weeks include maximal aerobic exercise capacity (primary outcome at 24 weeks), modifiable cardiovascular risk factors, exercise adherence, secondary prevention self-management behaviors, health-related quality of life, and adverse events. Economic and process evaluations will determine cost-effectiveness and participant perceptions of the treatment arms, respectively. RESULTS The trial was funded in November 2017 and received ethical approval in June 2018. Recruitment began in November 2018. As of September 2019, 54 participants have been randomized into the trial. CONCLUSIONS The innovative multiphase SCRAM intervention delivers real-time remote exercise supervision and evidence-based self-management behavioral support to participants, regardless of their geographic proximity to traditional center-based CR facilities. Our trial will provide unique and valuable information about effects of SCRAM on outcomes associated with cardiac and all-cause mortality, as well as acceptability and cost-effectiveness. These findings will be important to inform health care providers about the potential for innovative program delivery models, such as SCRAM, to be implemented at scale, as a complement to existing CR programs. The inclusion of a cohort comprising metropolitan-, regional-, and rural-dwelling participants will help to understand the role of this delivery model across health care contexts with diverse needs. CLINICALTRIAL Australian New Zealand Clinical Trials Registry (ACTRN): 12618001458224; anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374508. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/15022

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