HTA-ADAPTIVE ELEARNING TO IMPROVE DIETARY BEHAVIOUR
Data extraction manual
Review author: Enter the name of the person extracting the data.
Date: Enter the date of extraction.
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HTA-ADAPTIVE ELEARNING TO IMPROVE DIETARY BEHAVIOUR
Data extraction manual
Author: Name the trials first author’s last name. (For example, if the trial is Block, G., Miller, M., Harnack, L., Kayman, S., Mandel, S. and Cristofar, S. (2000). An interactive CD-ROM for nutrition screening and counselling. American Journal of Public Health, 90, 781-785, then enter Block).
Year of publication: Enter the year of publication of the trial in the peer-review journal. In the above example, it would be 2000. If the report is a grey literature (unpublished work) then enter the year that appears on the report.
Country: Specify the country where the intervention takes place.
Title: Name the title as it appears in the journal. E.g. ‘An interactive CD-ROM for nutrition screening and counselling’.
Aims & Objectives: Report the general questions the trial was designed to answer. It may be associated with one or more hypotheses that, when tested, would help answer the question.
I. METHODS
1. Recruitment (It is the process of getting participants into a randomized trial)(1-2):
i. Electronic: It is also called as internet or online recruitment where information technology (IT) is used for identifying and enrolling the participants.
ii. Mail shot: Participants are invited by postal mail along with the interest survey, and if interested, would return the interest survey by post. e.g.- Using random mailings
iii. Telephone: The interviewer calls the participants and conducts the screening by phone. e.g.- cold calls, Computer assisted telephone interviews/ Interactive voice response techniques.
iv. Advert in clinic: e.g.- fliers, brochures etc.
v. Advert elsewhere: Media advertising using television and/ or newspapers, press releases/public service announcements, posting fliers
vi. Social media networks: e.g.- Facebook, Twitter etc.
vii. Word of mouth, if the information about enrolling for the trial passed from person to person.
viii. Physician or health worker referral: Physician / GP or other registered health worker refers the participant to the trial.
ix. Organisation referral: If an organisation such as a health insurance company refers the participant to the trial
x. Other: If other, please specify
2. Study Design(3):
i. Parallel-group trials: Patients are randomised to the new treatment or to the standard treatment and followed-up to determine the effect of each treatment in parallel groups.
ii. Crossover trials: Patients are randomised to different sequences of treatments, but all patients eventually all treatments in varying order, i.e., the patient is his/her own control.
iii. Cluster randomised trials: the unit of randomisation is at the group level where randomisation of individuals is inappropriate. Examples of clusters are villages, factories or schools.
iv. Factorial trials: They assign patients to more than one treatment-comparison group. These are randomised in one trial at the same time, i.e., while drug A is being tested against placebo, patients are re-randomised to drug B or placebo, making four possible treatment combinations in total.
3. Randomisation - Sequence generation (The procedure used to obtain the (random) sequence for making intervention assignments)(4-5):
i. Simple randomisation, tossing a coin: heads may mean allocation to treatment A and tails to treatment B. Using randomisation lists prepared by this method ensures each patient has an equal chance of either treatment with no connection between assignments.
ii. Simple randomisation, random number table: A random number table is a listing of random numbers (for example, in a sequence of 100 randomised numbers from 0 -9, the numbers 0-4 is allocated to treatment A and 5-9 to treatment B.
iii. Simple randomisation, computerised random number generator: A random number generator is a process that produces random numbers using a statistical algorithm (for example, The Random Number Generator produces a Random Number Table consisting of 10 entries, where each entry is the number 1 or 2. The researchers then assign one intervention to volunteer number 1, the second to volunteer number 2, and so on.
iv. Random permuted blocks: here the number of patients allocated to each treatment is the same at certain points in the recruitment process. For example if a block size of 10 is used, then for each 'block' of 10 patients, five will be allocated to each treatment with the sequence of treatment allocations within each block ordered randomly.
v. Stratified randomisation is when randomisation with restriction is carried out separately within each of two or more subsets of participants (for example, defining disease severity or study centres) to ensure that the patient characteristics are closely balanced within each intervention group.
vi. Minimisation is a method to ensure close balance between treatment groups for several patient factors. The principle behind minimisation is that the treatment allocation for a particular patient is determined by the characteristics of the patients already entered into the trial (with the first patient allocated treatment using simple randomisation).
vii. Response-adaptive designs: There is a probability of being randomised to treatment in favour of the treatment that is showing more beneficial results so far for some outcome. For example, suppose that there are two treatment arms and that at the start of the study the probability of being randomised to either treatment group is equal (i.e. 50:50). As data accrue, one treatment is likely to show more favourable results, however small this benefit may seem. In a response-adaptive design, new participants would therefore be randomised to the treatment doing better with probability more than ½.
viii. Randomised consent design (Zelen design): when patients are randomised to one of two groups depending on consent- a) a group where no consent is asked and is assigned the standard group A and b) a group where patients are asked whether they are willing to accept the new treatment B. Patients unwilling to accept B are assigned to A.
4. Randomization - Allocation concealment (Method used to implement the random allocation sequence (e.g., numbered containers or central telephone), clarifying whether the sequence was concealed until interventions were assigned (6-7).
i. Centralised randomisation by telephone - automated: With this method, an investigator rings a central telephone number once the patient has given informed consent, gives the patient's details which register the patient before the allocation is given, and only then is the patient's allocated treatment group revealed. This 'allocation concealment' greatly reduces the risk of selection bias arising from the randomisation being subverted. A telephone randomisation service can be used both for randomisation with a fixed list (such as simple or stratified randomisation), or minimisation (where, treatments are assigned as patients enter the trial). The treatment assignment is done electronically (automated).
ii. Centralised randomisation by telephone – person: Same as above except that the treatment assignment is done by a person.
iii. Web-based randomisation: Investigators randomize patients with only a few clicks by simply completing an on-screen form with patient details and are immediately notified of the treatment allocation.
iv. Sequentially numbered, sealed envelopes: Here, as patients give informed consent and are entered into the trial, the investigator opens the next in a set of sequentially numbered sealed envelopes. Inside the envelope is the treatment assignment. The investigator may then be required to fax, send or email the patient's details to the trial coordinating centre if there is one.
v. Sealed envelopes not sequentially numbered or not opaque
vi. Random numbers read by someone not entering patients into trial (closed list)
vii. Random numbers read by someone entering patients into trial (open list)
5. Randomization –Implementation (6)
i. Who generated the allocation concealment?
ii. Who enrolled participants?
iii. Who assigned participants to their groups?
6. Analysis
i. Intention to treat analysis: A strategy for analyzing data in which all participants are included in the group to which they were assigned, whether or not they completed the intervention given to the group.
Intention-to-treat analysis prevents bias caused by the loss of participants, which may disrupt the baseline equivalence established by random assignment and which may reflect non-adherence to the protocol.
ii. Per protocol analysis: An analysis restricted to patients who adhered to their assigned treatment in a randomized trial (omitting patients who dropped out of the study or for other reasons did not actually receive the planned intervention).
7. Times at which outcomes measured:
Baseline: This consists of the data that are collected before randomisation. E.g., age, sex, symptoms etc.
0m: The data are collected immediately following the intervention.
1m /1 to <3m/3 to <6m/6 to <12m/12 to<24m/>24m: corresponds to the months when data were collected.
Other: Mention if data was collected at times other than the above. If other, please specify
8. Implementation fidelity/monitoring (8):
i. Does a protocol exist for the trial?
Indicate whether a protocol is known / confirmed to exist for this trial
ii. Was the protocol obtained to assess the adherence of the trial?
If a protocol exists for the trial, indicate if and where it can be accessed (e.g., Web address), and, if available, provide registration information including registration number.
iii. Was participants’ involvement/compliance monitored?
‘compliance refers to a parameter indicative of the quality and/or performance of a participant in a clinical trial, generally indicated by adherence to protocol, such as adherence to set procedures in a clinical trial, adherence to or achievement of certain goals of a clinical trial, such as enrolment goals, and/or any other parameter indicative of overall performance of a participant in a clinical trial’
iv. If yes, how was participants’ involvement / compliance monitored?
E.g. reviewing participant’s log-on data or assigning a personal password to each participant to monitor their website login frequency and use.
9. Incentives for participation: Did the participants receive any incentives (e.g. lottery system to win $20 gift cards in Student bodies 2 – Doyle 2008)?
10. Quality assessment
i. COCHRANE QUALITY ASSESSMENT
The Cochrane Collaboration’s tool for assessing risk of bias (1-5) (9)
1. Sequence generation (was the allocation sequence adequately generated?): Describe the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.
Yes No Unclear
2. Allocation concealment (was allocation adequately concealed?): Describe the method used to conceal the allocation sequence in sufficient detail to determine whether intervention allocations could have been foreseen in advance of, or during, enrolment.
Yes No Unclear
3. Blinding (was knowledge of the allocated intervention adequately prevented during the study?): Describe all measures used, if any, to blind study participants and personnel from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.
Yes No Unclear
4. Incomplete outcome data (were incomplete outcome data due to attrition and exclusions adequately addressed?): Describe the completeness of outcome data for each main outcome, including attrition and exclusions from the analysis. State whether attrition and exclusions were reported, the numbers in each intervention group (compared with total randomized participants), reasons for attrition/exclusions where reported, and any re-inclusions in analyses performed by the review authors.
Yes No Unclear
5. Selective reporting (are reports of the study free of suggestion of selective outcome reporting?): State how the possibility of selective outcome reporting was examined by the review authors, and what was found.
Yes No Unclear
6. Conflict of interest declared:
Yes No Unclear
ii. QUALITY ASSESSMENT TOOL FOR QUANTITATIVE STUDIES – EPHPP
(10-11)
COMPONENT RATINGS
A. Selection Bias
i. Are the individuals selected to participate in the study likely to be representative of the target population?
Participants are more likely to be representative of the target population if they are randomly selected from a comprehensive list of individuals in the target population (score very likely). They may not be representative if they are referred from a source (e.g. clinic) in a systematic manner (score somewhat likely) or self-referred (score not likely).
Very likely somewhat likely not likely can’t tell
ii. What percentage of selected individuals agreed to participate?
Refers to the % of subjects in the control and intervention groups that agreed to participate in the study before they were assigned to intervention or control groups.
80 - 100% agreement 60 – 79% agreement less than 60% agreement not applicable
can’t tell
RATINGS:
Strong: The selected individuals are very likely to be representative of the target population (Q1 is 1) and there is greater than 80% participation (Q2 is 1).
Moderate: The selected individuals are at least somewhat likely to be representative of the target population (Q1 is 1 or 2); and there is 60 - 79% participation (Q2 is 2). ‘Moderate’ may also be assigned if Q1 is 1 or 2 and Q2 is 5 (can’t tell).
Weak: The selected individuals are not likely to be representative of the target population (Q1 is 3); or there is less than 60% participation (Q2 is 3) or selection is not described (Q1 is 4); and the level of participation is not described (Q2 is 5).
B. Study Design
i. Indicate the study design
Cluster RCT RCT Controlled clinical trial Quasi RCT Factorial design Other
ii. Was the study described as randomized?
Score YES, if the authors used words such as random allocation, randomly assigned, and random assignment.
Score NO, if no mention of randomization is made.
No Yes
iii. If Yes, was the method of randomization described?