The SPIRIT 2013 statement – Defining standard protocol items for trials

IntroductionThe proper management of total knee arthroplasty (TKA) in patients with severe deformities regarding the preferable prosthetic design and the required amount of constraint is a controversial subject. In the absence of any high-level clinical evidence, we designed a randomised clinical trial to investigate if rotating hinged (RTH) and constrained condylar knee (CCK) designs yield similar outcomes.Methods and analysisThis study is a multicentre, randomised clinical trial including two groups of 85 patients. Patients will be randomised to a CCK knee design group or an RTH knee design group. Patients will be followed for 2 years. The study will be designed as an equivalence trial. The primary study outcome will be the postoperative functional outcome as measured by the self-administered Knee Injury and Osteoarthritis Outcome Score. Secondary outcomes will be postoperative joint awareness during various activities of daily living as measured by the Forgotten Joint Score-12, the Knee Society Score, along with the incidence and location of radiolucent lines using the Knee Society TKA radiographic evaluation system.Ethics and disseminationThis study is approved by the ethics committee of the Landesärztekammer Brandenburg ((S 10(a)/2013) from 27.08.2013, amended on 25.04.2016) and will be conducted according to the principles of the World Medical Association Declaration of Helsinki and the ISO14155:2011.Trial registration numberDRKS00010539.

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“…The study protocol was drafted following the SPIRIT statement23 and the CONSORT extension for reporting noninferiority and equivalence trials 24…”

Section: Methods and Analysismentioning

confidence: 99%

Constraint choice in revision knee arthroplasty: study protocol of a randomised controlled trial assessing the effect of level of constraint on postoperative outcome

et al. 2017

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“…Researchers are increasingly requested by funding agencies and peer-reviewed journals to share data and provide clear descriptions of analytic methods. Several standards for reporting research studies have been published by expert working groups to guide such documentation (61)(62)(63)(64). These guidelines should extend to the need for clear articulation of methods used to construct and analyze health system-generated data.…”

Section: Discussionmentioning

confidence: 99%

Construction and Use of Body Weight Measures from Administrative Data in a Large National Health System: A Systematic Review

Annis

Freitag

Evans

et al. 2020

Obesity

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Administrative data are increasingly used in research and evaluation yet lack standardized guidelines for constructing measures using these data. Body weight measures from administrative data serve critical functions of monitoring patient health, evaluating interventions, and informing research. This study aimed to describe the algorithms used by researchers to construct and use weight measures. Methods: A structured, systematic literature review of studies that constructed body weight measures from the Veterans Health Administration was conducted. Key information regarding time frames and time windows of data collection, measure calculations, data cleaning, treatment of missing and outlier weight values, and validation processes was collected. Results: We identified 39 studies out of 492 nonduplicated records for inclusion. Studies parameterized weight outcomes as change in weight from baseline to follow-up (62%), weight trajectory over time (21%), proportion of participants meeting weight threshold (46%), or multiple methods (28%). Most (90%) reported total time in follow-up and number of time points. Fewer reported time windows (54%), outlier values (51%), missing values (34%), or validation strategies (15%). Conclusions: A high variability in the operationalization of weight measures was found. Improving methods to construct clinical measures will support transparency and replicability in approaches, guide interpretation of findings, and facilitate comparisons across studies.

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“…The protocol of this trial, implementation, and reports will comply with the recommendations in Consolidate Standards of Reporting Trial (CONSORT). A Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) [ 28 ] diagram is provided in Additional file 1 .…”

Section: Discussionmentioning

confidence: 99%

The effects of combined exercise intervention based on Internet and social media software for postoperative patients with breast cancer: study protocol for a randomized controlled trial

Dong

Huang

et al. 2018

Trials

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BackgroundMany randomized controlled trials have investigated the effects of exercise on the rehabilitation of patients with breast cancer. However, the exercise forms used in most previous studies were monotonous. Therefore, we designed a protocol to estimate the effects of combined exercise intervention using Internet and social media software on the rehabilitation of postoperative patients with BC.Methods/DesignThis study protocol is a randomized control trial with an intervention time of 12 weeks. After completing baseline questionnaire and physical fitness tests, the participants are randomized to the study group or the control group. Procedure contents of exercise intervention in the study group include: via phone step-recording app, ask the individuals to complete the target number of steps within a specified period of exercise, four times per week; face-to-face remote video guidance of individuals on muscle training, three times per week; common knowledge of physical exercise BC rehabilitation will be pushed regularly by social media apps every day. The control group will receive normal treatment and rehabilitation according to daily specifications of the hospital. The primary outcome will be the quality of life. The secondary outcomes are physical fitness and social cognitive indicators.DiscussionThis study is a clinical trial to estimate the effects of combined exercise intervention based on the Internet and social media software for postoperative patients with breast cancer (BC). If expected results are achieved in this study, measures and methods of BC rehabilitation will be enriched.Trial registrationChinese Clinical Trial Register, ChiCTR-IPR-17012368. Registered on 14 August 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2857-3) contains supplementary material, which is available to authorized users.

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The SPIRIT 2013 statement – Defining standard protocol items for trials

Cited by 34 publications

References 19 publications

Constraint choice in revision knee arthroplasty: study protocol of a randomised controlled trial assessing the effect of level of constraint on postoperative outcome

Constraint choice in revision knee arthroplasty: study protocol of a randomised controlled trial assessing the effect of level of constraint on postoperative outcome

Construction and Use of Body Weight Measures from Administrative Data in a Large National Health System: A Systematic Review

The effects of combined exercise intervention based on Internet and social media software for postoperative patients with breast cancer: study protocol for a randomized controlled trial

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