scholarly journals How to write a research study protocol

Author(s):  
Julien Al Shakarchi

Abstract A study protocol is an important document that specifies the research plan for a clinical study. Many funders such as the NHS Health Research Authority encourage researchers to publish their study protocols to create a record of the methodology and reduce duplication of research effort. In this paper, we will describe how to write a research study protocol.

2020 ◽  
Vol 4 (1) ◽  
pp. 50-58
Author(s):  
Matthias  Tietsch ◽  
Amir Muaremi ◽  
Ieuan Clay ◽  
Felix Kluge ◽  
Holger Hoefling ◽  
...  

Analyzing human gait with inertial sensors provides valuable insights into a wide range of health impairments, including many musculoskeletal and neurological diseases. A representative and reliable assessment of gait requires continuous monitoring over long periods and ideally takes place in the subjects’ habitual environment (real-world). An inconsistent sensor wearing position can affect gait characterization and influence clinical study results, thus clinical study protocols are typically highly proscriptive, instructing all participants to wear the sensor in a uniform manner. This restrictive approach improves data quality but reduces overall adherence. In this work, we analyze the impact of altering the sensor wearing position around the waist on sensor signal and step detection. We demonstrate that an asymmetrically worn sensor leads to additional odd-harmonic frequency components in the frequency spectrum. We propose a robust solution for step detection based on autocorrelation to overcome sensor position variation (sensitivity = 0.99, precision = 0.99). The proposed solution reduces the impact of inconsistent sensor positioning on gait characterization in clinical studies, thus providing more flexibility to protocol implementation and more freedom to participants to wear the sensor in the position most comfortable to them. This work is a first step towards truly position-agnostic gait assessment in clinical settings.


The Lancet ◽  
1993 ◽  
Vol 341 (8855) ◽  
pp. 1272-1273
Author(s):  
Annette Tuffs

2020 ◽  
Vol 4 ◽  
pp. 89
Author(s):  
Elaine Charurat ◽  
Sara Kennedy ◽  
Siti Qomariyah ◽  
Anne Schuster ◽  
Megan Christofield ◽  
...  

Background: Global evidence suggests many postpartum and postabortion women have an unmet need for family planning (FP) after delivery or receiving care following loss of a pregnancy. Post Pregnancy Family Planning Choices, an operations research study, aims to examine the effectiveness of a package of postpregnancy FP interventions, inclusive of postpartum and postabortion FP. The interventions are being implemented in selected public and private facilities in Indonesia and Kenya and focus on quality FP counseling and service provision prior to discharge. This manuscript presents the study protocol, documenting how the study team intends to determine key factors that influence uptake of postpregnancy FP. Methods: This is a multi-country, quasi-experimental operations research study in Brebes and Batang Districts of Indonesia and Meru and Kilifi Counties of Kenya. Quantitative and qualitative data is collected from multiple data sources and participants through interviews and assessments at multiple time points. Participants include health facilities; antenatal, postpartum, and postabortion clients; and key informants at national, subnational, facility, and community levels. Quantitative study data is collected and managed through the use of REDCap (Research Electronic Data Capture). Once data are thoroughly cleaned and reviewed, regression models and multilevel analyses will explore quantitative data. Qualitative study data is collected using audio recordings and transcribed to Microsoft Word, then analyzed using ATLAS.ti. Qualitative datasets will be analyzed using grounded theory methods. Discussion: The ultimate goals of the study are to generate and disseminate actionable evidence of positive drivers, barriers, and activities that do not yield results with regard to increasing postpregnancy FP programmatic activities, and to institutionalize postpregnancy FP in the public and private sectors in Indonesia and Kenya. We hope these learnings and experience will contribute to global efforts to advance and scale up postpregnancy FP in similar settings beyond these two countries. Trial registration: ClinicalTrials.gov NCT03333473


2008 ◽  
Vol 8 (1) ◽  
Author(s):  
Deborah E Polk ◽  
Robert J Weyant ◽  
Richard J Crout ◽  
Daniel W McNeil ◽  
Ralph E Tarter ◽  
...  

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