Knowledge Base for Admins

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Knowledge Base for Patients

Bundles

Bundles are a group of questions for assessing the patient's condition and quality of life, logically grouped into 1 or more sections. The questions are taken from the PROMS (a Patient-Reported Outcomes Measurement Survey), ClinORs and custom patient- and clinical-oriented questionnaires. Bundles are the building blocks of Scoring Groups, and support the generation of Scores.

For example:

1. KOOS (Knee Injury and Osteoarthritis Outcome Score) is a self-reported questionnaire consisting of 42 questions that are divided into 5 groups, each of them has its own description and its own title: Pain (9 questions), other Symptoms (7 questions), Activity of Daily Living (ADL) (17 questions), Sports and Recreation Function (5 questions) and knee-related Quality of Life (QOL) (4 questions). On the inCytes™ platform  KOOS consists of 5 bundles

2. The 36-item Short Form Health Survey (SF-36) is a measure of health-related quality-of-life. The SF-36 consists of 36 questions. It yields an 8-scale profile including functional health, and mental health.

  • Physical health: Physical Functioning (10 questions), Bodily Pain (2questions), Role limitations due to physical health problems (4 questions), and general health perceptions (5 questions).
  • Mental health: role limitations due to personal or emotional problems (4 questions), emotional well-being (5 questions), social functioning (2 questions), energy/fatigue (4 questions).

On the inCytes™ platform SF-36 consists of 1 bundle.

Corresponding Clinician Articles

How to work with bundles

Interaction with the List of Bundles

  1. There are 3 columns:
    Name - title of the bundle.
    Modified - creation time or last change.
    Menus - icon with more options.
  2. The search for the necessary Bundle is carried out using the Bundle name, which can be entered in the search bar.
  3. There is pagination on the page. Only 25 bundle’s data are displayed. After scrolling down, other 25 bundles appear.
  4. Bundles are sorted by the modified column in descending order by default. The data can be sorted in ascending or descending order by clicking:
    ● on the Name column header - sort bundles in Z - A order, by next click - bundles in A - Z order.
    ● on the Modified column header- sort bundles from the earliest to the latest order, by next click- from the latest to the earliest order.

Create New Bundle

  1. Start with Bundles at the left-hand navigation.
  2. Press the blue button + Bundle at the top right corner of the screen.
  3. Fill in the required Name.
  4. Press the Create button.
● For Bundles Name use the full version of PROM and the abbreviation in parentheses (e.g.: Knee Injury and Osteoarthritis Outcome Score (KOOS)) or a logical section from a validated source, for example for KOOS ("KOOS Quality Of Life", "KOS Function, Sports and Recreational Activities", "KOOS Function, Daily Living", "KOOS Pain", "KOOS Symptoms").

● The names are written with uppercase letters except for minor words (typically articles, short prepositions, and some conjunctions)

Add Read only Content

Read only Content includes a subtitle and body copy.

  • The name of the bundle can be used as a subtitle
  • Body copy may consist of a description of the disease to which the bundle is dedicated, information on how many questions are in it, and how the patient should answer.
  1. Click on the one of the Bundle.
  2. Click on the Plus icon and select Read only Content option.
  3. Fill in Read only Content data.
  4. Press the Save button

Add Question to the Bundle

  1. Click on the one of the Bundle.
  2. Click on the Plus icon and select Question.
  3. Click Create New button and select the necessary type of question (or search on Question name in the search bar for existing one).
  4. Fill in Tag, Question*, Instruction, Possible Answers* (Tag is unique questions’ elements in Surveys and Bundles consisting of: [PROM Abbreviation] [Section Name] [Q+sequential number in the survey] (e.g.: KOOS Symptoms Q2)) (All questions should follow sentence capitalization (Only first word is capitalized))
    (*- the required fields).
  5. Press the Save button.

How to Edit and Localize Questions in Bundle

  1. Click on the one of the Bundle.
  2. Select the Language and click 3 dots next to the Question.
  3. Click Edit.
  4. Change the Question data.
  5. Click the Save button.
Edits to English values would overwrite the values for other languages if they were not set previously.

Remove Questions from the Bundle

Check our article on archiving questions in a bundle.

Do I always have the ability to remove questions from a bundle?

Yes, but we don't recommend deleting questions from a bundle.
(See Detailed explanation in Removing a question from bundle)

Display and Localization

  1. The patient can see the survey with bundles after creating a case for this patient on the investigators portal.

If the bundle was localized to the preferable patient’s language, e.g. if the translation to that language was inserted when localizing the bundle, then the bundles are displayed according to the patient portal language settings.

If the bundle was not translated to the preferable language, then the patient sees English version of the bundle

  1. An investigator is able to see bundles on:

1. Case Detail page

Before filling in the survey with bundles by the patient
After filling in the data by the patient

2. Exported files from Circle details and Report Builder pages- on Legends tab. The scores are loaded as an answer to the bundle's question. Each survey, scoring group, question type, and questions has its own sequence number.

  • Single Select → 1
  • Multiple Select → 2
  • Grouped → 6
  • Analog → 9
  • Number → 6

Question type represented as 'QT'+[QuestionTypeId] → Name of Question Type

Survey represented as 'S'+[SurveyId] → Name of survey

Scoring Group represented as 'SG'+[ScoringGroupId] → Name of Scoring Group

Questions represented as 'Q'+[QuestionId] → Question Title

Is it possible to download text answers that are associated with numbers?

No. The answers are downloaded only in the form of a score.

  1. An inCytes™ administrator is able to see bundles on:
    ● Scoring groups Formula page - question tags are used in the Formula Builder;
    ● Surveys Detail page - Tags, Questions, Answers are displayed in the language of currently selected language tab;
    ● Protocols Versions page (Pre-Treatment, Treatment, Post-Treatment stage are displayed in English)

How my changes impact the existing cases

  1. Adding a new question to bundle
    The question can be added to the bundle if the patient has not yet filled out the survey on the Benchmark (patient’s portal).
    If the survey is answered on the patient’s portal, the investigator can create a new case with a question added to the bundle.
  1. Editing a question in bundle
  • change wording
    Change writing or wording is a valid value on the admin portal . The patient and the investigator will see the changes in the survey.
  • change score associated to the answer
    This action may lead to a change in the scores in the scoring group for the survey and observational protocol. You can see changes in Report Builder in scores and the Total score.
    If the patient has not completed the survey, then the administrator has the opportunity to change the score
Before
After
  • adding a new option as an answer
    This action won’t entail any changes if the survey is already filled in on the patient portal.
  1. Reordering question in bundle

Using the arrows next to the question, the administrator has the opportunity to reorder questions in the bundle. The change in the order of questions will be displayed in the survey on the investigator’s portal and in the unfilled survey on the patient portal.

  1. Removing a question from bundle
    Questions which have been asked and answered in at least one survey can’t be removed, because this action may lead to a change in the scores in the scoring group.

Frequently Asked Questions (F.A.Q)

1. What are the types of questions in the bundle?

There are 2 sections- select and fill in - which consist of 6 types of questions:

  • single value - a question type in which respondents have to select one response from a given list of options. Single value questions are denoted by radio buttons.
  • multiple value - a question type in which respondents have to select one or many responses from a given list of options. Multiple value questions are denoted by check-boxes.
  • grouped - a question type in which respondents use radio buttons scale from 0-10 to assess the intensity or frequency of various symptoms.
  • analog - a question type in which respondents use a slider scale to assess the intensity or frequency of various symptoms. For example, the amount of pain a patient experiences ranges from zero to a very severe level of pain (for example) from 1 to 10.
  • number - a question type in which respondents have to enter a numeric answer in the input field and answers are allowed to have an accepted error range.
  • file - a question type which is used to collect information beyond the survey questions, such as user-uploaded photos or documents.
  • date - a question type in which respondents are to enter the date (treatment date, birthdate, commencement date, etc)
2. Can a bundle consist only of a single type (multiple, analog...) questions?

Yes. For example : WOMAC (The Western Ontario and McMaster Universities Arthritis Index ). Widely used in the evaluation of Hip and Knee Osteoarthritis. It consists of 24 single type questions and divided into 3 subsections : pain, stiffness, physical functioning of the joints.

3. Can a bundle consist only of one question?

Yes. For example: VAS (Visual Analog Scale) has only one question that is used as an individual Bundle. VAS is a unidimensional measure of pain intensity. For pain intensity, the scale is most commonly anchored by “no pain” (score of 0) and “pain as bad as it could be” or “unbearable pain” (10)

4. Must I put scores to all questions?

No. Scores are used in 2 types of questions: single and multiple values. Number, grouped, analog questions do not require to have the score associated to them as the value given directly as the answer is the Score itself.

5. Can I add 0 as a numeric value?

Yes, you can. 0 is the minimum numeric value.

6. If some patients are not expected to answer the question they complete Prom/ ClinOr, how should I add it to the bundle?

Add a question and make it optional by clicking the checkbox “Is optional”.

7. Will it be a problem if a similar question already exists in another bundle?

No, it won’t. The question's uniqueness is determined by the tag.

8. Will it be a problem if there are two identical bundles with the same names?

Yes, it will. In the future you will face the problem of choosing the correct bundle for the Scoring Group. Contact the Dev team to help you remove an extra bundle.

9. What if there are 12 questions in the bundle in the English version, and 11 in the localized version (e.g. Italian)?

In this case, a new localized bundle with 11 questions is being built.