How to write a research study protocol

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.

Study protocol for a national retrospective review of femoral periprosthetic fracture management. Is there variation in practice?

Introduction The incidence of femoral periprosthetic fractures (PPFs) in the UK is on the rise. This rising incidence presents a clinical and an economic burden on the national health care services. There is also uncertainty about the most effective treatment modality for femoral PPFs, as well as a lack of evidence for a standardized management approach. We aimed to identify the true incidence and any variation in the management of femoral PPFs nationally. Methods and analysis This multicentre national collaborative study has been designed by a trainee led research network in collaboration with a well-established university research organization. Data will be collected from participating centres over a period of 10 years (2010–2019). All adults presenting with a femoral PPF will be identified, and the mode of treatment for each fracture subtype will be recorded. Other measures will evaluate patient and treatment variables, objective and subjective outcome measures. Univariate and multivariate regression analyses will be used, as well as the coefficient of determination (R) in an attempt to measure the degree to which the models could explain the variation in management. Ethics and dissemination This multicentre national project was approved by the local clinical governance department at each participating hospital site. The results of this study will be submitted to international peer reviewed journals and appropriate national and international conferences.

Determining the global outcomes of traumatic brain injury in low-, middle- and high- income countries: a prospective, global neurosurgery, multicenter cohort study (Global NeuroSurg 1 Study Protocol)

Globally, traumatic brain injury (TBI) affects 69 million individuals every year. However, there are wide variations in the management of TBI across low-, middle- and high-income countries which reflects on the outcomes of TBI worldwide. This study aims to provide a comprehensive global picture of the surgical and nonsurgical management and outcomes of TBI. The Global NeuroSurg 1 study is a prospective international multicentre cohort study conducted in self-selected registered centers. Any hospital receiving and managing TBI patients is eligible to participate (registration through www.globalneurosurg.org). After obtaining institutional ethical approvals, collaborator teams collect consecutive TBI patient data within any 2 weeks from the 1 June 2019 to the 30 September 2021 with 90 days of follow-up for every patient. Data items include (1) patient demographics, (2) TBI timing, severity and mechanism, (3) clinical status of the patient, (4) radiographic findings, (5) surgical and nonsurgical management and (6) patient survival and Glasgow outcome score. All data are submitted to the secure RedCap system of Oregon Health and Science University, OR. Binary logistic regression analysis will be conducted to evaluate the predictors of 30-day mortality. The odds ratios and the corresponding 95% confidence intervals will be calculated for each variable. Then variables that are independently contributing to the mortality will be selected and examined. Study ethical approvals or ethical approval waivers are obtained from all participating centers. All collected data are kept confidential and will be used only for the purpose of this study.