PARAGON Data Extraction Form New

Welcome to the Data Extraction Form for the Scoping Survey: Research Intervention "Pretreatment Activity and Rehabilitation for neoAdjuvant Gynecology Oncology Patients" (PARAGON)
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Email
example@example.com
Date Form Completed

MonthDayYear
Date
Name of person extracting data
Enter the Covidence Abstract Number
Enter the last name, first initial of the first author
Enter the Title of the Article:*
Select the year the study was published:

INFORMATION:

This is regarding the DEMOGRAPHICS data from you paper only. Choose YES, if your article DID NOT provide totals combining all of the group means and use the table below, the total means will then be calculated for you.

If this was not the case, and your article provided entire combined group demographics please say no, and click the link HERE below
HERE.
NOTE: PLEASE RECORD ONLY MEAN AGE AND PERCENT MALE VS FEMALE. NO OTHER DEMOGRAPHIC INFORMATION NEEDS TO BE ENTERED BELOW. Was the Demographic data reported for the 2 or 3 groups separately with no calculated group totals? If yes use the chart below for you to input that the data for each group separately (the calculations are done automatically for you just enter the cells for the individual groups not the totals) if no just move past the chart to the next questions.

yesNoOther
How many groups were there?

If DEMOGRAPHIC data listed for 2-3 groups separately simply enter the data here for the 2-3 groups (You do not need to calculate the Totals, the form will calculate it for you if you enter the other data): IF THERE WAS NO group 3 - just leave blank

	Group 1	Group 2	Group 3	Total N, Mean Age, Mean SD Groups 1 and 2	Total N, Mean Age, Mean SD, All Groups
Enrolled N
N female
N Male
Mean Age
Age Standard Deviation (SD) OMIT

Group 1 row 1 enrolled n
Group 2 row 1 enrolled N
Group 3 row 1 Enrolled N
Mean Age Group 1 column 1 4th cell
Mean Age Group 2 column 2 4th cell
Mean Age Group 3 column 3 4th cell
Mean SD Group 1 column 1 5th cell
Mean SD Group 2 column 2 5th cell
Mean SD Group 3 column 3 5th cell
total N Females Group 1 column 1 second cell
total N Females Group 2 column 2 second cell
total N Females Group 3 column 3 second cell
total N Males group 1 column 1 third cell
total N Males group 2 column 2 third cell
total N Males group 3 column 3 third cell
What was the total N enrolled in the Study?
What was the sample gender?
Total Sample Mean Age (for all groups combined, can get from table above)
Total Sample Mean Age Standard Deviation (SD) (for all groups combined, can get from table above)
Total N Female (for all groups combined, can get from table above)
Total N Male (for all groups combined, can get from table above)
OMIT. Is race reported in demographic table?

YesNoOther
% White/Caucasian in total sample
OMIT. Were there any statistically significant differences in demographic or clinical characteristics between intervention groups at baseline?

YesNoOther

If intervention adherence was assessed, describe how and by whom, and if any strategies were used to maintain or improve adherence, please briefly list them (if you need to paste please keep it brief) NOTE - if you paste, please correct the line breaks in the paragraph to extend all the way in the box - thank you!:
Were there any strategies or tools put into place PRIOR to the intervention to maintain adherence? For example by noting patient preferences, goals? Educational materials? Phone call or zoom?
If Yes explain:
Where did these strategies to assist participant adherence PRIOR to the intervention take place if there were any? For example: "The patients were provided a zoom session prior at home."
OMIT TABLES. Tables Below:

The table below conern only the functional outcome test measures (There are examples on the last tab or in the FAQs pages).

Clinical significance refers to the "difference" in the measure and if it is of clinical significance to the patient, versus statistical significance. Many papers will not report this, however if we have the means, and how they changed we can determine it ourselves later. It may be reported by MCIDs (Minimal clinically important differences) or MDCs, (minimal detectable change) and then how much above these their outcomes improved. These could be in percentages, a score, medians, T or F values, or most commonly as a Cohen's D and the paper will report it etc. Please see the last page or the FAQs sheet for further definition. The paper may report this is a clinical significance as well, however not report a value.

The statistical significance will be from the specific statistical tests, and those will be defined by what value the article chooses as their level of significance. So this is typically the p < .05 or p=.002 etc. Or a Confidence Interval will be provided like 25 [12,46]. These are statisical differences
OMIT TABLES. For the following tables, please choose from the following study group comparisons.
Please select 1 from the following

The study compared 1 group onlyThe study compared 1 group with multiple timepoints (More than just pre/post intervention)The study compared 2 groups on of which could have been a control, or another intervention groupThe study compared at 2 groups with more than 2 time pointsThe study compared more than 2 groups
OMIT. For the following tables, please refer to the outcomes you listed on page 3 or the outcomes tab. You can click the tab to return to that page.
For the table below please restate here the FUNCTIONAL outcomes the study reported (up to 3)

If the table above does not allow you to accurately depict your articles findings, please use this space to type what you feel would be helpful (if you need to paste, please try to be as brief as possible) NOTE - if you paste, please correct the line breaks in the paragraph to extend all the way in the box - thank you!:

If the table above does not allow you to accurately depict your articles findings, please use this space to type what you feel would be helpful NOTE - if you paste, please correct the line breaks in the paragraph to extend all the way in the box - thank you!:

If the table above does not allow you to accurately depict your articles findings, please use this space to type what you feel would be helpful (If you need to paste, please keep it brief, your own words are ideal, they can be brief) NOTE - if you paste, please correct the line breaks in the paragraph to extend all the way in the box - thank you!:

If the table above does not allow you to accurately depict your articles findings, please use this space to type what you feel would be helpful (If you need to paste, please keep it brief, your own words are ideal, they can be brief) NOTE - if you paste, please correct the line breaks in the paragraph to extend all the way in the box - thank you!:

If the table above does not allow you to accurately depict your articles findings, please use this space to type what you feel would be helpful (If you need to paste, please keep it brief, your own words are ideal, they can be brief) NOTE - if you paste, please correct the line breaks in the paragraph to extend all the way in the box - thank you!:

OMIT THIS PAGE. Results II Organized by Study Design with Dynamic Response Options Based on Selections

This is for the collection of the results and the numeric data
Please select which study design type for which you are reporting results

One Group Assessed Pre and Post Intervention2 Groups - Assessed pre and post intervention only (2 Intervention groups, or an Intervention and Control/Comparison Group)2 or more groups assessed with 3 or more time points (2 Intervention groups, or an Intervention and Control/Comparison Group)3 GroupsOther
Results for ONE group with Functional Outcome Measures Assessed Pre and Post Intervention, If you had more than one outcome measure simply click the Add Another at the bottom and add the results for the outcome measure, if needed you can explain further in the box below:
For results of studies with 1 group assessed pre post if more information needed or you would like to copy and paste results you can use this space. NOTE - if you paste, please correct the line breaks in the paragraph to extend all the way in the box - thank you!:
You can paste can upload a screenshot or image of your table of results if it is then saved as an image as well here as well; accepts all file types. If you can crop your pdf down to just the table, that will work as well. (To view later, please copy url, and paste in your web engine and it is viewable)

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Comparing 2 groups. This table is to report the Group ONE WITHIN Group Results -
Comparing 2 groups. This table is to report the Group TWO WITHIN Group Results -
Comparing two groups: This table is to report the BETWEEN group differences for the Functional Outcome Measure Results. This could be either 2 Intervention groups or an Intervention and Control Group, If you had more than one Outcome measure click the Add Another at the bottom
Comparing 2 groups with 3 -4 time points. If there is not a 3 third time point leave blank and complete pre post final. This table is to report the Group ONE WITHIN Group Results -
For results of studies with 2 groups assessed if more information needed or you would like to copy and paste results you can use this space. NOTE - if you paste, please correct the line breaks in the paragraph to extend all the way in the box - thank you!:
Comparing 2 groups with 3-4 time points. This table is to report the Group TWO WITHIN Group Results -
For results of studies with 2 groups assessed if more information needed or you would like to copy and paste results you can use this space. NOTE - if you paste, please correct the line breaks in the paragraph to extend all the way in the box - thank you!:
Comparing 2 groups with 3-4 time points. This table is to report the BETWEEN Group Results -
For results of studies with 2 groups assessed if more information needed or you would like to copy and paste results you can use this space. NOTE - if you paste, please correct the line breaks in the paragraph to extend all the way in the box - thank you!:
You can paste can upload a screen shot or image of your table of results if it is then saved as an image as well here as well; accepts all file types. If you can crop your pdf down to just the table, that will work as well.

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If you had 3 Groups this table is to enter your WITHIN Group Results - Enter Group ONE HERE
If you had 3 Groups this table is to enter your WITHIN Group Results - Enter Group TWO HERE
If you had 3 Groups this table is to enter your WITHIN Group Results - Enter Group THREE HERE
Results for BETWEEN GROUPS if Your Study had 3 Groups -- This is to enter the results BETWEEN GROUP 1 and GROUP 2
Results for BETWEEN GROUPS if Your Study had 3 Groups -- This is to enter the results BETWEEN GROUP 1 and GROUP 3
Results for BETWEEN GROUPS if Your Study had 3 Groups -- This is to enter the results BETWEEN GROUP 2 and GROUP 3
For results of studies with 3 groups if more information needed or you would like to copy and paste results you can use this space.
You can paste can upload a screen shot or image of your table of results if it is then saved as an image as well here as well; accepts all file types. If you can crop your pdf down to just the table, that will work as well.

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Brief summary of study conclusions NOTE - if you paste, please correct the line breaks in the paragraph to extend all the way in the box - thank you!:
Copy-paste intervention protocol from publication if able: NOTE - if you paste, please correct the line breaks in the paragraph to extend all the way in the box - thank you!:
Any limitations to the study? NOTE - if you paste, please correct the line breaks in the paragraph to extend all the way in the box - thank you!:
Other positive or supportive findings: NOTE - if you paste, please correct the line breaks in the paragraph to extend all the way in the box - thank you!:
Describe adverse events, if not reported write N/A
List any concerns or comments for the article
Does the article suggest future research? If so copy and paste here, or briefly list.
Please put suggestions here for improvement of form. Just click the + button to add another suggestion line -

Outcomes

REMINDER!  The focus of this scoping review is to determine what changes, if any, impacted the FUNCTIONAL outcomes only which includes both patient reported (a survey) and performance based (such as 6MWT) Therefore please report only the functional The primary outcome of your article, might not be functional, but the secondary may be functional.
We have tried below to provide options where you can delineate whether the primary outcome was a functional outcome or not, and to limit your reporting to the functional outcomes only.
There are options to list the other outcomes that were included, please put the other outcomes that were not functional there but they are not used for analysis.
We would like to only collect the critical information about the FUNCTION OUTCOMES.
We have tried to compile a list of as many functional outcomes as possible that may be used in these articles, however we may not have captured them all.
If there is any question, and you are not sure whether it is or not, please email me kutinak@duq.edu because it is not always obvious.

Adherence measure

In healthcare and medical research, adherence measures assess individuals' adherence to prescribed treatments or recommendations, aiding in monitoring and identifying factors influencing patient adherence. These may be provided in percentages, rates of drop out, days completed etc.

Implementation Ouctomes Definitions and Understanding:

Effectiveness (Does it work… in the real world?)

Process of delivery (How does it work?)

Acceptability (Will people be willing to use it?)

Cost (How much does it cost to implement?)

Appropriateness (Is this the right intervention?)

Reach (How many people are exposed and benefit?)

Intensity (What is the expected strength of the intervention?)

Satisfaction (Are stakeholders satisfied and to what degree?)

Sustainability (Can it be continued over time?)

Effectiveness

The PROMIS Physical Function portion is scored on a 0-point to 100-point scale, with a population mean of 50 and SD of 10.

Intervention Componentry

Frequency, Dosage, Intensity

Frequency-

How often was the intervention provide on a cyclicle basis, if it was once, then it was a singular session, however that is not typically what is ideal. Frequency is usally 2x per week for 4 weeks.

Intensity

Intensity has been referred to as the “frequency of repetitions of the desired movement”, “amount of external work” , or “amount of time that is dedicated to practice”

We define intensity as: the amount of physical or mental work put forth by the patient during a particular movement or series of movements, exercise, or activity during a therapy session.

Dosage -

How many of what type of exercise (weights, biking for time, exercise band for 2 sets of 10, etc)

The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk in older adults. It is an objective measure with the patient starting seated in a chair, and they rise and walk, turn, and walk back to chair. Certain scores on this are associated with a meaningful change. These may be defined in the article they may not, but if you report the score, we can determine that information.

The 6 minute walk test (6MWT) assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance.

Functional Outcome:

These can be measured by performance based tests, with objective measures such as walking speed and endurance and can also be patient reported measures of function found in surveys or questionnaires. Functional outcomes measure a patient's physical, psychological, or social functioning resulting from a medical intervention. These outcomes reveal the impact on a patient's well-being and help professionals understand treatment effects on daily life.

Health-Related Quality of Life (HRQOL): HRQOL are typically surveys with measures that encompass a broader assessment of a patient's well-being, considering physical, emotional, social, and mental aspects of life.

Prehabiliation:

In terms of prehabilitation, we are looking for rehabilitation, activity, exercise - monitored, or independent -, as well as other modalities provided to the patient PRIOR to their neoAdjuvant chemotherapy, primarily, however most of the literature is prior to surgery.

Control Group:

A control condition serves as a reference point to measure the effects of an experimental treatment, providing a baseline for outcome assessment. Typically is the usual standard of care provided and then compared to the intervention.

Remote support:

Remote support involves providing healthcare services, guidance, and monitoring from a distance using telecommunication technologies. We re interested in if this was provided to determine if it should be included in our intervention to provide the patients support between visits or during their activity prior to treatment.

Statistically significant:

A statistically significant outcome indicates a meaningful and reliable difference or relationship between groups or variables. This may be defined by whatever level of significance is set and then p is < or .05, or it may be an F score, or a T score, in the outcomes table, asking which outcome were the results in favor of, there is a place to put this value.

Clinically Significant Differences:

Effectiveness

The PROMIS Physical Function portion is scored on a 0-point to 100-point scale, with a population mean of 50 and SD of 10.

Minimal Clinical Impportant Difference (MCID)

MCID in the context of a 6-Minute Walk Test (6MWT) means "Minimal Clinically Important Difference." It signifies the slightest significant change in 6MWT distance, This aids healthcare professionals, researchers, and patients determine whether a post-intervention distance change is clinically meaningful.

Cohen’s D ( if the paper reports an effect size, this would be helpful to jot down in the "other" section or with the outcome measure in results. Somes this is reported as its own number, or it can be an F value.

Cohen's d quantifies effect size (how much actualy clinical improvement or decline there was pre and post intervention that is meaningful clinically) in medical research, precisely: The standardized difference between two compared groups or conditions, helping assess clinical significance using standard deviation units. It aids in evaluating treatment effects or medical outcome differences.

MDC (Minimal Detectable Change) - the slightest reliably detectable change in a variable with a specified confidence level. This outcome is frequently used to see if there was any significant clinical improvement that can be inferred by how well the patient did on the outcome measure or test.
References:

1. Meagan M. Wasfy, MD; Aaron L. Baggish, MD,." Exercise Dose in Clinical Practice". Circulation. 2016;133:2297-2313.
2. Gaizka Goikoetxea-Sotelo 1 , 2 , 3 , † and Hubertus J. A. van Hedel. "Defining, quantifying, and reporting intensity, dose, and dosage of neurorehabilitative interventions focusing on motor outcomes." Front Rehabil Sci. 2023; 4: 1139251.
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	Clinical Significance?	Did the results favor the intervention (statistical Significance) ?	Which outcome demonstrated the most change? (Please type outcome e.g. 6MWT)
Outcome 1
Outcome 2
Outcome 3

	Statistical and Clinical Significance Timepoint 1	Statistical and Clinical Significance Time point 2	Statistical and Clinical Significance Time point 3	Statistical and Clinical Significance Final	Which OUTCOME demonstrated the most change (Please type outcome e.g. 6MWT)?
Outcome 1
Outcome 2
Outcome 3

	Intervention group	Control Group	Which GROUP demonstrated the most improvement in the outcomes?	Clinical Significance	Which OUTCOME demonstrated the most change (Please type outcome e.g. 6MWT)?
Outcome 1
Outcome 2
Outcome 3

	Intervention group	Control Group	Which Group had the most improvements at data collection 1?	Which Group had the most statistical improvement at data collection 2?	Which group had the most statistical improvement at time point 3?	Which group had the most improvement at the final data collection point?	Clinical Significance point 1	Clinical Significance point 2	Cllinical significance point 3	Clinical Significance Final	Which OUTCOME demonstrated the most change (Please type outcome e.g. 6MWT)?
Outcome 1
Outcome 2
Outcome 3

	Intervention group 1	Intervention group 2	Intervention group 3	Control Group	Which GROUP demonstrated the most improved outcomes?	Did the intervention improve outcomes but the result was not statistically significant?	Which OUTCOME demonstrated the most improvement (Please type outcome e.g. 6MWT)?
Outcome 1
Outcome 2
Outcome 3

Welcome to the Data Extraction Form for the Scoping Survey: Research Intervention "Pretreatment Activity and Rehabilitation for neoAdjuvant Gynecology Oncology Patients" (PARAGON)

WHAT(procedures): Describe each of the procedures, activities,and/or processes used in the intervention, including any enabling or support activities.

Mode of Delivery of Intervention

OMIT THIS PAGE. Results II Organized by Study Design with Dynamic Response Options Based on Selections

The outcomes below are selected as a few common Functional Outcome Measures used in this population, however if you have already reported for these above, you can leave them blank.