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. 2021 May 18;17(2):e1165. doi: 10.1002/cl2.1165
1. Bibliographic information
Article ID FREETEXT
Linked articles FREETEXT
Extracted by FREETEXT
Checked by FREETEXT
Year of publication FREETEXT
Type of publication
  • 1.

    Journal Article

  • 2.

    Book/book chapter

  • 3.

    Government report

  • 4.

    Conference proceedings

  • 5.

    Presentation

  • 6.

    Thesis or Dissertation

  • 7.

    Unpublished report

  • 8.

    Other (please specify)

Location of study

The location in which the study is set not where the study authors are based.

  • 1.

    UK

  • 2.

    ROI

  • 3.

    Rest of Europe

  • 4.

    USA

  • 5.

    Canada

  • 6.

    South America

  • 7.

    Central America

  • 8.

    Oceania

  • 9.

    Middle‐East

  • 10.

    Asia

  • 11.

    Africa

  • 12.

    Other (Please Specify)

Not Specified
Study funding sources
  • 1.

    Research council funding

  • 2.

    University scholarships and bursaries

  • 3.

    Salaried research assistantships from university departments

  • 4.

    Grants or loans from trusts and charities

  • 5.

    Local enterprise initiatives

  • 6.

    Company sponsorship

  • 7.

    Government loans

  • 8.

    EU Scholarships

  • 9.

    Industry sponsorship

  • 10.

    Other (please specify)

Possible conflicts of interest
  • 1.

    Yes, possible/definite conflict of interest

  • 2.

    No, study appears to be free of CoI

  • 3.

    Can't tell

2. Participant information

Recruitment setting

Where were participants recruited from?

  • 1.

    Clinical setting

  • 2.

    Accommodation for individuals experiencing homelessness

  • 3.

    Family home

  • 4.

    The street

  • 5.

    Community setting

  • 6.

    Referred by friends or family

  • 7.

    Referred by medical health professional

  • 8.

    Housing Agency

  • 9.

    Other (Please specify)

Homelessness Status at intake

Describe the housing status of the sample at intake and/or any information given about housing status prior to intake. Tick all that apply and try to extract numbers were available.

Homelessness is defined as those individuals who are sleeping 'rough' (sometimes defined as street homeless), those in temporary accommodation (such as shelters and hostels), those in insecure accommodation (such as those facing eviction or in abusive or unsafe environments), and those in inadequate accommodation (environments which are unhygienic and/or overcrowded).

  • 1.

    Sleeping 'Rough' (or rooflessness)

  • 2.

    Temporary Accommodation

  • 3.

    Insecure Accommodation

  • 4.

    Inadequate Accommodation

  • 5.

    Involuntary sharing, for example, domestic violence

  • 6.

    Hidden/concealed homelessness

  • 7.

    Other (please specify)

Not Specified

Geographical context

Where participants receive treatment?

  • 1.

    Urban

  • 2.

    Rural

  • 3.

    Suburban

  • 4.

    Mixed

  • 5.

    Other (please specify)

Not Specified

Gender

% (actual number)

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Age

Extract mean age, SD and range.

Choose multiple options if the analysis is reported separately for different age groups.

  • 1.

    Under 25

  • 2.

    25 and Over

Complexity of needs

What other challenges does the individual face, if any, aside from the risk or experience of homelessness?

High Risk of Harm and/or Exploitation ‐ For example, women in shelters, newcomer families, refugee/asylum seeker, care leavers

  • 1.

    Poor Physical Health

  • 2.

    Poor Mental Health

  • 3.

    Incarceration

  • 4.

    Substance Abuse Issues

  • 5.

    Care leaver

  • 6.

    Limited access to integrated support services

  • 7.

    High Risk of Harm and/or Exploitation

  • 8.

    Other (please specify)

Not RelevantNot Specified
Mental health status
  • 1.

    Receiving treatment

  • 2.

    Not receiving treatment

  • 3.

    Other (please specify)

Not relevant
Not Specified
Substance use status
  • 1.

    Receiving treatment

  • 2.

    Not receiving treatment

  • 3.

    Other (please specify)

Not relevant
Not Specified

Homelessness status

Homelessness is defined as those individuals who are sleeping “rough” (sometimes defined as street homeless), those in temporary accommodation (such as shelters and hostels), those in insecure accommodation (such as those facing eviction or in abusive or unsafe environments), and those in inadequate accommodation (environments which are unhygienic and/or overcrowded).

  • 1.

    Sleeping “rough”

  • 2.

    Temporary accommodation

  • 3.

    Insecure accommodation

  • 4.

    Inadequate accommodation

  • 5.

    Other (please specify)

Not Specified

Family vs. No Family

Family = any child involved

Non‐family = single person or couple without children

If mixed sample select both and describe

  • 1.

    Family

  • 2.

    Non‐Family

Not Specified
Sample size of treatment groupNumber of people assigned to treatment. If more than one treatment group extract all and be clear which group is which. FREETEXT

Sample size of control group

Number of people assigned to control. If more than one control group extract all and be clear which group is which.

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3. Intervention information

How many intervention arms in this trial?

List how many study arms there are and given each a name. e.g. Intervention = Critical Time Intervention; Control = Treatment as usual

If there is more than one intervention arm go to the "Study Arm" tab and add the RELEVANT study arms. You must then extract data for each relevant study arm.

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Name of intervention

Write in the name of the program, intervention, or treatment under study. This may be specific like “critical time intervention” or it may be something more generic like “supported housing”

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Briefly Describe the intervention

Briefly describe the intervention, what participants are offered and any important factors such as conditionality, nature of housing, case management, substance abuse treatment included etc.

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Theory of change

How does the intervention aim to bring about change? What is the underlying theoretical rationale for why the intervention might work to improve outcomes?

If not specified write "not specified"

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What is the size of accommodation/How many beds? FREETEXT

Duration of treatment period from start to finish

In the dosage items, we are interested in the amount of treatment received by the participants. If the treatment was delivered directly to participants, the authors will probably provide at least some information about dosage and you can code these items accordingly. If minimal information is provided, you should try to give estimates for these items if you can come up with a reasonable estimate.

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Timing

Frequency of contact between participants and provider/program activity

1. Once a month2. Less than weekly3. Once a week4. 1‐2 times a week5. 2 times a week6. 2‐3 times a week7. 3 times a week8. 3‐4 times a week9. 4 times a week10. Daily contactCan't Estimate

Length of each individual session

How long does each contact/session last?

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Study Personnel

The primary individual/s who have direct contact with the participants served by the program.

If the report is the author's dissertation (or based on the author's dissertation), then code as "Graduate Researcher".

If the delivery is performed by graduate or undergraduate students assisting the author then select "Grad/Undergrad Students".

Code “Self‐directed” for studies where electronic/computer programs are used.

If the intervention is solely environmental i.e. community housing, then code “environmental change”

  • 1.

    Graduate Researcher

  • 2.

    Grad/Undergrad Students

  • 3.

    Author

  • 4.

    Homelessness professional

Includes case manager, social worker, outreach worker
  • 5.

    Peers

  • 6.

    Interventionist (Not Hired by Researcher)

  • 7.

    Interventionist (Hired by Researcher)

  • 8.

    Self‐Directed

  • 9.

    Medical Professionals

  • 10.

    Other (please specify)

Not Specified

Did provider receive specialised training?

This refers to whether or not the “interventionist” received specialised training to equip them to deliver the intervention proficiently.

  • 1.

    Yes

  • 2.

    The interventionist IS program developer

  • 3.

    No

Not specified

Resource requirements

Time, staff, housing provision etc

FREETEXT
Cost FREETEXT
4a. Study Design

Design

The studies included in all reviews must include an intervention group and at least one untrained control group. Control groups can include placebo, no treatment, waitlist, or treatments vs “treatment as usual.” Any study which includes one group pre‐test/post‐test or in which a treatment group is only compared to another treatment group will not be eligible for inclusion.

  • 1.

    Randomised control trial

Individual or cluster randomised
  • 2.

    Non‐randomised control trial

What do control subjects receive?
  • 1.

    Placebo

  • 2.

    Treatment as usual

  • 3.

    No treatment

  • 4.

    Not specified

  • 1.

    Placebo (or attention) treatment. Group gets some attention or a sham treatment

  • 2.

    Treatment as usual. Group gets “usual” handling instead of some special treatment.

  • 3.

    No treatment. Group gets no treatment at all.

Unit of allocation

Individual (i.e., some were assigned to treatment group, some to comparison group)

Group (i.e., whole subsets assigned to treatment and comparison groups)

Regions (i.e., region assigned as an intact unit)

  • 1.

    Individual

  • 2.

    Group

  • 3.

    Regions

  • 4.

    Other (Please Specify)

Not Specified
Method of assignment
  • 1.

    Randomly after matching

  • 2.

    Randomly without matching

  • 3.

    Regression discontinuity design

  • 4.

    Cluster assigned

  • 5.

    Wait list control

  • 6.

    Non‐random, but matched

  • 7.

    Other (Please Specify)

Method of group assignment. How participants/units were assigned to groups. This item focuses on the initial method of assignment to groups, regardless of subsequent degradations due to attrition, refusal, etc. prior to treatment onset.
  • 1.

    Randomly after matching, yoking, stratification, blocking, etc. The entire sample is matched or blocked first, then assigned to treatment and comparison groups within pairs or blocks. This does not refer to blocking after treatment for the data analysis.

  • 2.

    Randomly without matching, etc. This also includes cases when every other person goes to the control group.

  • 3.

    Regression discontinuity design: quantitative cutting point defines groups on some continuum (this is rare).

  • 4.

    Cluster assigned, this is to be used in cluster assignment studies only, specify the number of clusters in the treatment group and the number of clusters in control.

  • 5.

    Wait list control or other quasi‐random procedure presumed to produce comparable groups (no obvious differences). This applies to groups which have individuals apparently randomly assigned by some naturally occurring process, e.g. first person to walk in the door. The key here is that the procedure used to select groups doesn't involve individual characteristics of persons so that the groups generated should be essentially equivalent.

  • 6.

    Non‐random, but matched: Matching refers to the process by which comparison groups are generated by identifying individuals or groups that are comparable to the treatment group using various characteristics of the treatment group. Matching can be done individually, e.g., by selecting a control subject for each intervention subject who is the same age, gender, and so forth, or on a group basis.

Not Specified

Was there >20% attrition in either/both groups?

Attrition occurs when participants are lost from an intervention over time or over a series of sequential processes. Studies may describe this as “lost to follow‐up,” or “drop outs.”

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4b. Non‐random studies

How were groups matched?

If matching was used prior to assignment of condition, how were groups matched?

  • 1.

    Matched on Pre‐test measure

  • 2.

    Matched on personal characteristics

  • 3.

    Matched on demographics

  • 4.

    Groups weren't matched

  • 5.

    Other (please specify)

Not specified
Was the equivalence of groups tested at pre‐test? FREETEXT
Results of statistical comparisons of pre‐test differences
  • 1.

    No statistically significant differences

  • 2.

    Significant differences judged unimportant by coder

  • 3.

    Significant differences judged of uncertain importance by coder

  • 4.

    Significant differences judged important by coder

  • 5.

    Other (please specify)

Were there pre‐test adjustments? FREETEXT
5. Qualitative information
Qualitative methods used FREETEXT
Data analysis technique and procedure FREETEXT
Was the intervention implemented as intended?
  • 1.

    Yes

  • 2.

    No

Not specified
How was this measured? FREETEXT
What implementation and process factors impact intervention delivery?
  • 1.

    Contextual factors

  • 2.

    Policy makers/funders

  • 3.

    Programme managers/Implementing agency,

  • 4.

    Staff/case workers

  • 5.

    Recipients

6. Assessing quality in RCTs (Cochranes ROB2 tool)
Domain 1: Risk of bias arising from the randomization process
1.1 Was the allocation sequence random?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

Risk‐of‐bias judgement
  • 1.

    Low

  • 2.

    High

  • 3.

    Some concerns

Optional: What is the predicted direction of bias arising from the randomization process?
  • 1.

    Favours experimental

  • 2.

    Favours comparator

  • 3.

    Towards null

  • 4.

    Away from null

  • 5.

    Unpredictable

Domain 2: Risk of bias due to deviations from the intended interventions (effect of assignment to intervention)
2.1. Were participants aware of their assigned intervention during the trial?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

2.2. Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

2.4. If Y/PY to 2.3: Were these deviations from intended intervention balanced between groups?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

2.5 If N/PN/NI to 2.4: Were these deviations likely to have affected the outcome?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

Risk‐of‐bias judgement
  • 1.

    Low

  • 2.

    High

  • 3.

    Some concerns

Optional: What is the predicted direction of bias due to deviations from intended interventions?
  • 1.

    Favours experimental

  • 2.

    Favours comparator

  • 3.

    Towards null

  • 4.

    Away from null

  • 5.

    Unpredictable

Domain 3: Missing outcome data
3.1 Were data for this outcome available for all, or nearly all, participants randomized?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

3.4 If Y/PY/NI to 3.3: Do the proportions of missing outcome data differ between intervention groups?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

3.5 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

Risk‐of‐bias judgement
  • 1.

    Low

  • 2.

    High

  • 3.

    Some concerns

Optional: What is the predicted direction of bias due to missing outcome data?
  • 1.

    Favours experimental

  • 2.

    Favours comparator

  • 3.

    Towards null

  • 4.

    Away from null

  • 5.

    Unpredictable

Domain 4: Risk of bias in measurement of the outcome
4.1 Was the method of measuring the outcome inappropriate?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

4.3 If N/PN/NI to 4.1 and 4.2: Were outcome assessors aware of the intervention received by study participants?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

Risk‐of‐bias judgement
  • 1.

    Low

  • 2.

    High

  • 3.

    Some concerns

Optional: What is the predicted direction of bias in measurement of the outcome?
  • 1.

    Favours experimental

  • 2.

    Favours comparator

  • 3.

    Towards null

  • 4.

    Away from null

  • 5.

    Unpredictable

Domain 5: Risk of bias in selection of the reported result
5.1 Was the trial analysed in accordance with a pre‐specified plan that was finalized before unblinded outcome data were available for analysis?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

Is the numerical result being assessed likely to have been selected, on the basis of the results, from…
5.2. … multiple outcome measurements (e.g. scales, definitions, time points) within the outcome domain?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    4. No

5.3 … multiple analyses of the data?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

Risk‐of‐bias judgement
  • 1.

    Low

  • 2.

    High

  • 3.

    Some concerns

Optional: What is the predicted direction of bias due to selection of the reported result?
  • 1.

    Favours experimental

  • 2.

    Favours comparator

  • 3.

    Towards null

  • 4.

    Away from null

  • 5.

    Unpredictable

Overall risk of bias
Risk‐of‐bias judgement
  • 1.

    Low

  • 2.

    High

  • 3.

    Some concerns

7. Assessing quality in Non‐random control trials (ROBINS‐I tool)
Bias due to confounding

1.1 Is there potential for confounding of the effect of intervention in this study?

If N/PN to 1.1: the study can be considered to be at low risk of bias due to confounding and no further signalling questions need be considered

  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

If Y/PY to 1.1: determine whether there is a need to assess time‐varying confounding:
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

1.2. Was the analysis based on splitting participants' follow up time according to intervention received?If N/PN, answer questions relating to baseline confounding (1.4 to 1.6)If Y/PY, go to question 1.3.
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

1.3. Were intervention discontinuations or switches likely to be related to factors that are prognostic for the outcome?

If N/PN, answer questions relating to baseline confounding (1.4 to 1.6)

If Y/PY, answer questions relating to both baseline and time‐varying confounding (1.7 and 1.8)

  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

Questions relating to baseline confounding only
1.4. Did the authors use an appropriate analysis method that controlled for all the important confounding domains?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

1.5. If Y/PY to 1.4: Were confounding domains that were controlled for measured validly and reliably by the variables available in this study?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

1.6. Did the authors control for any post‐intervention variables that could have been affected by the intervention?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

Questions relating to baseline and time‐varying confounding
1.7. Did the authors use an appropriate analysis method that controlled for all the important confounding domains and for time‐varying confounding?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

1.8. If Y/PY to 1.7: Were confounding domains that were controlled for measured validly and reliably by the variables available in this study?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

Risk‐of‐bias judgement
  • 1.

    Low

  • 2.

    Moderate

  • 3.

    Serious

  • 4.

    Critical

Optional: What is the predicted direction of bias due to confounding?
  • 1.

    Favours experimental

  • 2.

    Favours comparator

  • 3.

    Unpredictable

Bias in selection of participants into the study

2.1. Was selection of participants into the study (or into the analysis) based on participant characteristics observed after the start of intervention?

If N/PN to 2.1: go to 2.4

  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

2.2. If Y/PY to 2.1: Were the post‐intervention variables that influenced selection likely to be associated with intervention?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

2.3 If Y/PY to 2.2: Were the post‐intervention variables that influenced selection likely to be influenced by the outcome or a cause of the outcome?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

2.4. Do start of follow‐up and start of intervention coincide for most participants?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

2.5. If Y/PY to 2.2 and 2.3, or N/PN to 2.4: Were adjustment techniques used that are likely to correct for the presence of selection biases?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

Risk‐of‐bias judgement
  • 1.

    Low

  • 2.

    Moderate

  • 3.

    Serious

  • 4.

    Critical

Optional: What is the predicted direction of bias due to selection of participants into the study?
  • 1.

    Favours experimental

  • 2.

    Favours comparator

  • 3.

    Towards null

  • 4.

    Away from null

  • 5.

    Unpredictable

Bias in classification of interventions
3.1 Were intervention groups clearly defined?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

3.2 Was the information used to define intervention groups recorded at the start of the intervention?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

3.3 Could classification of intervention status have been affected by knowledge of the outcome or risk of the outcome?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

Risk‐of‐bias judgement
  • 1.

    Low

  • 2.

    Moderate

  • 3.

    Serious

  • 4.

    Critical

Optional: What is the predicted direction of bias due to classification of interventions?
  • 1.

    Favours experimental

  • 2.

    Favours comparator

  • 3.

    Towards null

  • 4.

    Away from null

  • 5.

    Unpredictable

Bias due to deviations from intended interventions
If your aim for this study is to assess the effect of assignment to intervention, answer questions 4.1 and 4.2
4.1. Were there deviations from the intended intervention beyond what would be expected in usual practice?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

4.2. If Y/PY to 4.1: Were these deviations from intended intervention unbalanced between groups and likely to have affected the outcome?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

If your aim for this study is to assess the effect of starting and adhering to intervention, answer questions 4.3 to 4.6
4.3. Were important co‐interventions balanced across intervention groups?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

4.4. Was the intervention implemented successfully for most participants?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

4.5. Did study participants adhere to the assigned intervention regimen?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

4.6. If N/PN to 4.3, 4.4 or 4.5: Was an appropriate analysis used to estimate the effect of starting and adhering to the intervention?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

Risk‐of‐bias judgement
  • 1.

    Low

  • 2.

    Moderate

  • 3.

    Serious

  • 4.

    Critical

Optional: What is the predicted direction of bias due to deviations from the intended interventions?
  • 1.

    Favours experimental

  • 2.

    Favours comparator

  • 3.

    Towards null

  • 4.

    Away from null

  • 5.

    Unpredictable

Bias due to missing data
5.1 Were outcome data available for all, or nearly all, participants?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

5.2 Were participants excluded due to missing data on intervention status?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

5.3 Were participants excluded due to missing data on other variables needed for the analysis?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

5.4 If PN/N to 5.1, or Y/PY to 5.2 or 5.3: Are the proportion of participants and reasons for missing data similar across interventions?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

5.5 If PN/N to 5.1, or Y/PY to 5.2 or 5.3: Is there evidence that results were robust to the presence of missing data?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

Risk of bias judgement
  • 1.

    Low

  • 2.

    Moderate

  • 3.

    Serious

  • 4.

    Critical

Optional: What is the predicted direction of bias due to missing data?
  • 1.

    Favours experimental

  • 2.

    Favours comparator

  • 3.

    Towards null

  • 4.

    Away from null

  • 5.

    Unpredictable

Bias in measurement of outcomes
6.1 Could the outcome measure have been influenced by knowledge of the intervention received?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

6.2 Were outcome assessors aware of the intervention received by study participants?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

6.3 Were the methods of outcome assessment comparable across intervention groups?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

6.4 Were any systematic errors in measurement of the outcome related to intervention received?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

Risk of bias judgement
  • 1.

    Low

  • 2.

    Moderate

  • 3.

    Serious

  • 4.

    Critical

Optional: What is the predicted direction of bias due to measurement of outcomes?
  • 1.

    Favours experimental

  • 2.

    Favours comparator

  • 3.

    Towards null

  • 4.

    Away from null

  • 5.

    Unpredictable

Bias in selection of the reported result
Is the reported effect estimate likely to be selected, on the basis of the results, from…
7.1. … multiple outcome measurements within the outcome domain?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

7.2 … multiple analyses of the intervention‐outcome relationship?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

7.3 … different subgroups?
  • 1.

    Yes

  • 2.

    Probably yes

  • 3.

    Probably No

  • 4.

    No

Risk of bias judgement
  • 1.

    Low

  • 2.

    Moderate

  • 3.

    Serious

  • 4.

    Critical

Optional: What is the predicted direction of bias due to selection of the reported result?
  • 1.

    Favours experimental

  • 2.

    Favours comparator

  • 3.

    Towards null

  • 4.

    Away from null

  • 5.

    Unpredictable

Overall risk of bias
Risk‐of‐bias judgement
  • 1.

    Low

  • 2.

    Moderate

  • 3.

    Serious

  • 4.

    Critical

8. Assessing quality in Qualitative studies (White and Keenan tool)
Are the evaluation questions clearly stated?
  • 1.

    Yes

  • 2.

    No

Is the qualitative methodology described?
  • 1.

    Yes

  • 2.

    No

Is the qualitative methodology appropriate to address the evaluation questions?
  • 1.

    Yes

  • 2.

    No

  • 3.

    Insufficient detail

Is the recruitment or sampling strategy described?
  • 1.

    Yes

  • 2.

    No

Is the recruitment or sampling strategy appropriate to address the evaluation questions?
  • 1.

    Yes

  • 2.

    No

  • 3.

    Insufficient detail

Are the researcher's own position, assumptions and possible biases outlined?
  • 1.

    Yes

  • 2.

    No

Have ethical considerations been sufficiently considered?
  • 1.

    Yes

  • 2.

    No

  • 3.

    Insufficient detail

Is the data analysis approach adequately described?
  • 1.

    Yes

  • 2.

    No

Is the data analysis sufficiently rigorous?
  • 1.

    Yes

  • 2.

    No

Is there a clear statement of findings?
  • 1.

    Yes

  • 2.

    No

Are the research findings useful?
  • 1.

    Yes

  • 2.

    No