AGENCY:
Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION:
Request for supplemental evidence and data submission.
SUMMARY:
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Management of Suicidal Thoughts and Behaviors in Youth, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
DATES:
Submission Deadline on or before June 21, 2024.
ADDRESSES:
Email submissions: epc@ahrq.hhs.gov.
Print submissions:
Mailing Address: Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, Attn: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857
Shipping Address (FedEx, UPS, etc.): Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD 20857
FOR FURTHER INFORMATION CONTACT:
Kelly Carper, Telephone: 301-427-1656 or email: epc@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION:
The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for Management of Suicidal Thoughts and Behaviors in Youth. AHRQ is conducting this review pursuant to Section 902 of the Public Health Service Act, 42 U.S.C. 299a.
The EPC Program is dedicated to identifying as many studies as possible that are relevant to the questions for each of its reviews. In order to do so, we are supplementing the usual manual and electronic database searches of the literature by requesting information from the public ( e.g., details of studies conducted). We are looking for studies that report on Management of Suicidal Thoughts and Behaviors in Youth. The entire research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/suicidal-thoughts-youth/protocol.
This is to notify the public that the EPC Program would find the following information on Management of Suicidal Thoughts and Behaviors in Youth helpful:
A list of completed studies that your organization has sponsored for this topic. In the list, please indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number.
For completed studies that do not have results on ClinicalTrials.gov, a summary, including the following elements, if relevant: study number, study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, primary and secondary outcomes, baseline characteristics, number of patients screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, effectiveness/efficacy, and safety results.
A list of ongoing studies that your organization has sponsored for this topic. In the list, please provide the ClinicalTrials.gov trial number or, if the trial is not registered, the protocol for the study including, if relevant, a study number, the study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, and primary and secondary outcomes.
Description of whether the above studies constitute ALL Phase II and above clinical trials sponsored by your organization for this topic and an index outlining the relevant information in each submitted file.
Your contribution is very beneficial to the Program. Materials submitted must be publicly available or able to be made public. Materials that are considered confidential; marketing materials; study types not included in the review; or information on topics not included in the review cannot be used by the EPC Program. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter.
The draft of this review will be posted on AHRQ's EPC Program website and available for public comment for a period of 4 weeks. If you would like to be notified when the draft is posted, please sign up for the email list at: https://effectivehealthcare.ahrq.gov/email-updates.
The review will answer the following questions. This information is provided as background. AHRQ is not requesting that the public provide answers to these questions.
Key Questions (KQ)
KQ 1. For youth, what are the effectiveness, comparative effectiveness, and harms of treatments for suicidal thoughts and behaviors?
(a) What are the components of effective psychosocial treatments ( e.g., frequency or intensity of therapy and/or aspects of the therapeutic modality)?
(b) How do social determinants of health, racism and disparities, care delivery methods, patient demographics and psychiatric or developmental co-occurring conditions affect outcomes?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and Setting)
| PICOTS elements | Inclusion criteria | Exclusion criteria |
|---|---|---|
| Population | • Ages 5-24 years who have a heightened risk for suicide, including— ○ Those who have suicidal ideation ( i.e., thinking about or planning suicide) with or without self-injurious behaviors ( i.e., suicide attempt or self-injurious behavior, including self-directed deliberate injury or potential for injury) ○ Those who have made suicide attempts in the absence of known suicidal ideation ○ Those who have a recent hospital discharge for mental health treatment ○ Those who have shown command hallucination ( i.e., auditory hallucinations that instruct a patient to act in specific manners) or intense stress/distress ○ Those who are identified as having heightened risk by PHQ-9, C-SSRS, or ASQ ○ Those who are from racial/ethnic minority groups known to have increased risk of suicide ○ Those who are from the LGBTQ+ community ○ Those who have/had exposure to high crime/violence | • Animals. • Adults aged >25 years. |
| Interventions | • An intervention aimed to reduce suicidal and thoughts behaviors— ○ Psychosocial interventions ○ Pharmacological therapy ○ Neurotherapeutics and emerging therapies ○ Combination therapies of the above | • Complementary or integrative health interventions ( e.g., light therapy, supplements). |
| Comparators | • Treatment as usual • Another psychosocial intervention • Another pharmacological therapy • Combination therapies of the above | • None. |
| Outcomes | • Suicidal behaviors ( e.g., suicidal attempts, self-harm with suicidal intent, self-harm without suicidal intent) • Suicidal ideation • Measures of severity of suicide ideation and intent ( e.g., C-SSRS, Sheehan STS, SIQ) • Deaths by suicide • Hospitalizations for suicidal thoughts or behaviors • Emergency department visits for suicidal thoughts or behaviors • Measures of psychological functioning after receiving an intervention targeting suicidal behaviors and thoughts ( e.g., depression, anxiety, stress, coping, sense of purpose, agency, burdensomeness, thwarted belonging as reported by child and caregivers, quality of life • School outcomes [ e.g., functioning in school, attendance, drop-out]) • Adverse events, including study withdrawals | • None. |
| Timing | • At the end of intervention and at the end of followup | • None. |
| Settings | • Any ( e.g., outpatient, inpatient, emergency department) | • None. |
| Study design | • RCTs • Comparative observational studies • Before—after studies • Relevant systematic reviews, or meta-analyses (used for identifying additional studies) | • In vitro studies. • Nonoriginal studies ( e.g., narrative reviews, editorials, letters, or erratum). • Cross-sectional ( i.e., nonlongitudinal) studies. |
| Subgroup analysis | • Delivery methods ( e.g., telehealth, in-home treatment, school-based intervention, clinic) • Age group (5-13 years, 14-17 years, and 18-24 years) • Gender/gender identity • Race/ethnicity • History of trauma • Experience of racial/ethnic discrimination and marginalization • Sexual orientation • Co-occurring conditions ( e.g., MDD, bipolar disorder, mood disorders, substance use disorders, eating disorders, posttraumatic stress disorder, autism, intellectual/developmental disabilities, other special needs), • Intervention objectives ( i.e., addressing suicidal thoughts vs. suicidal behaviors; ongoing treatments following crisis care vs. crisis care) • Clinical settings ( e.g., outpatient, inpatient, residential, emergency department) • Timing of outcome assessment ( e.g., long-term outcome assessment, short-term outcome assessment) • Social determinants of health ( e.g., access to mental healthcare, access to housing, poverty, exposure to violence/crime) | • None. |
| Publications | • Full-text peer-reviewed studies published in English • Studies published after the year 2000 | • Non-English language studies. • Conference abstracts. |
| Abbreviations: ASQ = Ask Suicide-Screening Questions; C-SSRS = Columbia Suicide Severity Rating Scale; LGBTQ+ = Lesbian Gay Bisexual Transgender Queer/Questioning Plus/Others; MDD = major depressive disorder; PHQ-9 = Patient Health Questionnaire-9; RCT = randomized controlled trial; Sheehan STS = Sheehan Suicidality Tracking Scale; SIQ = Suicidal Ideation Questionnaire. |
Dated: May 16, 2024.
Mamatha Pancholi,
Deputy Director.
[FR Doc. 2024-11197 Filed 5-21-24; 8:45 am]
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