Step 1. Critical:  all else depends on your finding a Randomized Controlled (Clinical) Trial Peer-Reviewed Journal Article (Level II Evidence)  Review Figure 1.1,~ p. 13 of your textbook for the Level of Evidence Pyramid, which shows an RCT is at Level II. When you communicate with physicians about an article, they respect the article more when it is at least on the Level II evidence pyramid, which suggests more credibility and possibly better input regarding outcomes of care.  Find your peer-reviewed Randomized Controlled Trial (RCT) article related to your area of interest.  If you are not sure of how to find articles using our DCN Databases,do the following:

  1. Go to the DCN Home Page
  2. Notice that there are 3 columns and 3 rows, each with a green heading category.  Go to the second row, first column, and click on Databases. Once your see the top heading, Database Access, look below and see “For DCN Students: Database Use Tutorial (MP4 Recording). Study the tutorial, and it will assist you in finding a Randomized Controlled (Clinical) Trial article
  3. If you need further assistance with finding an article after you review the tutorial, email Mr. Madsen, Director of the LRC. He has a Masters of Library Services degree, and can assist you in finding articles that you may not be able to access. If you find an article that charges a fee, e-mail Mr. Madsen the article you need, and he can usually get the full text article for you at no charge. His email address is [email protected].

Step 2.  Once you have your article, read it, and then look at the CONSORT Checklist, and write the page number in the article that has the information the checklist requires. (FYI, researchers who publish their research use this checklist to be sure they have everything in their article, or it is often not accepted by premier scholarly publishers). The checklist is worth 25 points, as it takes time and discernment to do it correctly.

Step 3:  Once your fill out the CONSORT CHECKLIST (25 points), you must then write a formal summary of the Analysis of Strengths and Weaknesses (worth 8 points) that you will notice is on the CONSORT checklist. The following steps are to assist you in distilling the specifics for what is required in the Analysis of Strengths and Weaknesses for the CONSORT checklist. .

Step 4  Specifics of the ANALYSIS OF STRENGTHS AND WEAKNESSES.  Review ~p. 9 of your research textbook, and then note how to write
 

  1. Introduction  (1 point)

                   + Purpose of the RCT (discuss)

  1. Overall Strengths and Weaknesses  (1 point) 

                  +  Research Design (Discuss)

                  +  Important Findings

  1. Reliability and Validity  (2 points) (Check the 

     methods, instruments, measurements or 

     procedures sections of article); statistics; Level of Evidence and 

     implications; cause-effect measurement; any threats to internal

     or external validity

  1. Ethics (1 point)

                  +  IRB? +Conflict of Interest +Informed Consent Signed

  1. Topic/Summary  (2 points)

                 + Implications 

                 + Limitations

                 + Recommendation(s)

STUDY PROTOCOL Open Access

A multi-component cognitive behavioural
intervention for the treatment of fear of
falling after hip fracture (FIT-HIP): protocol
of a randomised controlled trial
Maaike N. Scheffers-Barnhoorn1*, Jolanda C. M. van Haastregt2, Jos M. G. A. Schols2, Gertrudis I. J. M. Kempen2,
Romke van Balen1,3, Jan H. M. Visschedijk1, Wilbert B. van den Hout4, Eve M. Dumas5, Wilco P. Achterberg1

and Monica van Eijk1

Abstract

Background: Hip fracture is a common injury in the geriatric population. Despite surgical repair and subsequent
rehabilitation programmes, functional recovery is often limited, particularly in individuals with multi-morbidity. This
leads to high care dependency and subsequent use of healthcare services. Fear of falling has a negative influence
on recovery after hip fracture, due to avoidance of activity and subsequent restriction in mobility. Although fear of
falling is highly prevalent after hip fracture, no structured treatment programme is currently available. This trial will
evaluate whether targeted treatment of fear of falling in geriatric rehabilitation after hip fracture using a
multi-component cognitive behavioural intervention (FIT-HIP), is feasible and (cost) effective in reducing fear of
falling and associated activity restriction and thereby improves physical functioning.

Methods/design: This multicentre cluster randomised controlled trial will be conducted among older patients with
hip fracture and fear of falling who are admitted to a multidisciplinary inpatient geriatric rehabilitation programme
in eleven post-acute geriatric rehabilitation units. Fifteen participants will be recruited from each site. Recruitment
sites will be allocated by computer randomisation to either the control group, receiving usual care, or to the
intervention group receiving the FIT-HIP intervention in addition to usual care. The FIT-HIP intervention is
conducted by physiotherapists and will be embedded in usual care. It consists of various elements of cognitive
behavioural therapy, including guided exposure to feared activities (that are avoided by the participants).
Participants and outcome assessors are blinded to group allocation. Follow-up measurements will be performed at
3 and 6 months after discharge from geriatric rehabilitation. (Cost)-effectiveness and feasibility of the intervention
will be evaluated. Primary outcome measures are fear of falling and mobility.

Discussion: Targeted treatment of fear of falling may improve recovery and physical and social functioning after
hip fracture, thereby offering benefits for patients and reducing healthcare costs. Results of this study will provide
insight into whether fear of falling is modifiable in the (geriatric) rehabilitation after hip fracture and whether the
intervention is feasible.

Trial registration: Netherlands Trial Register: NTR 5695.

Keywords: Fear of fall

image1.jpg
CONSORT 2010 checklist of information to include when reporting a randomised trial*

Section/Topic

Item No

Checklist item

Reported on page No

Title and abstract

1a

Identification as a randomised trial in the title

1b

Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts)

Introduction

Background and objectives

2a

Scientific background and explanation of rationale

2b

Specific objectives or hypotheses

Methods

Trial design

3a

Description of trial design (such as parallel, factorial) including allocation ratio

3b

Important changes to methods after trial commencement (such as eligibility criteria), with reasons

Participants

4a

Eligibility criteria for participants

4b

Settings and locations where the data were collected

Interventions

5

The interventions for each group with sufficient details to allow replication, including how and when they were actually administered

Outcomes

6a

Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed

6b

Any changes to trial outcomes after the trial commenced, with reasons

Sample size

7a

How sample size was determined

7b

When applicable, explanation of any interim analyses and stopping guidelines

Randomisation:

 Sequence generation

8a

Method used to generate the random allocation sequence

8b

<

1

Running Head: CONSORT OF RANDOMIZED CLINICAL TRIAL

2

CONSORT OF RANDOMIZED CLINICAL TRIAL

Application of the CONSORT Statement to a Randomized Trial of Low-Dose Aspirin in Preventing Cardiovascular Disease in Women

Author

School

Exemplar of CONSORT Assignment

Analysis of Strengths and Weaknesses

Introduction

The following analysis relates to the article by Ridker, Cook, Lee, Gordon, Gaziano, Manson, Hennekens, Buring (2005). The purpose of this Randomized Clinical Trial (RCT) was to determine if low-dose aspirin should be recommended as a strategy for prevention of cardiovascular disease for women age 45 or greater.

Overall Strengths and Weaknesses

There was a decrease in Cardiovascular events for women who received the aspirin as compared to women who received the placebo. In addition, the ischemic stroke risk decreased by 30%. The method of randomization was unclear, as well as the method for blinding (Author, 2016).

Reliability and Validity

The statistics used compared aspirin and placebo groups using the Relative Risk, P values, cumulative incidence rates, and 95% confidence intervals. There was no explanation of how the authors selected these methods in terms of time, e.g. pre-specified or commencement after the initiation of the trial (Author, 2018). This is a Level II trial, which is at a higher level of evidence if the researchers follow the protocols for a Level II trial, and overall these researchers did. The RCT had randomization, intervention and control groups, as well as manipulation of the independent variable, which provides strength in studying the cause-effect relationship. Following these Level II design requirements reduces the threats to internal and external validity LoBiondo-Wood & Haber, 2018).

Ethics

The Institutional Review Board did monitor the study, and informed consent was signed by those participating as subjects in this study .

Topic, Summary

This is an important topic and the need to determine whether low-dose aspirin should be utilized needs to be analyzed. Since this study was completed in 2005, much new information is available that renders the findings of this study lacking for generalization of the clinical applications to women in this age group.

References

American Psychological Association. (2009). Publication manual of the American

Psychological Association (6th ed.). Washington, DC: Author.

Author, (n.d.) Application of C