Supplemental Evidence and Data Request on Treatment of Stage I-III Squamous Cell Anal Cancer, 60681-60683 [2023-19031]
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Federal Register / Vol. 88, No. 170 / Tuesday, September 5, 2023 / Notices
service providers to adopt a robocall
mitigation program and file a
description of that program in the
Robocall Mitigation Database as well as
requiring all classes of providers to file
additional information in the Robocall
Mitigation Database. On May 18, 2023,
the Commission adopted an Order
modifying some of these requirements.
See Call Authentication Trist Anchor, et
al., WC Docket No. 17–97 et al., Seventh
Report and Order et al., FCC 23–37
(adopted May 18, 2023).
Federal Communications Commission.
Marlene Dortch,
Secretary, Office of the Secretary.
[FR Doc. 2023–19073 Filed 9–1–23; 8:45 am]
BILLING CODE 6712–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Treatment of Stage I–III
Squamous Cell Anal Cancer
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for supplemental
evidence and data submissions.
AGENCY:
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
Treatment of Stage I–III Squamous Cell
Anal Cancer, which is currently being
conducted by the AHRQ’s Evidencebased 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Access to published and unpublished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 October 5, 2023.
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
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:02 Sep 01, 2023
Jkt 259001
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 Treatment of Stage I–III
Squamous Cell Anal Cancer. 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 Treatment of Stage I–III
Squamous Cell Anal Cancer. The entire
research protocol is available online at:
https://effectivehealthcare.ahrq.gov/
products/anal-cancer-treatment/
protocol.
This is to notify the public that the
EPC Program would find the following
information on Treatment of Stage I–III
Squamous Cell Anal Cancer helpful:
D 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.
D 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.
D 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.
D Description of whether the above
studies constitute ALL Phase II and
above clinical trials sponsored by your
organization for this topic and an index
PO 00000
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Fmt 4703
Sfmt 4703
60681
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://
www.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. What are the effectiveness and
harms of different modalities of initial
treatment for stages I–III squamous cell
anal cancer?
KQ 2. What are the effectiveness and
harms of different modalities of
radiation therapy for initial treatment of
stages I–III squamous cell anal cancer?
KQ 3. What are the effectiveness and
harms of different radiation therapy
doses, volumes, and fractionation
schema for initial treatment of stage I–
III squamous cell anal cancer?
KQ 4. What are the effectiveness and
harms of different combinations of
chemotherapy and radiation therapy,
and dose de-escalation or dose
escalation for initial treatment of stages
I–III squamous cell anal cancer?
KQ 5. What are the effectiveness and
harms of immunotherapy for initial
treatment of stages I–III squamous cell
anal cancer?
KQ 6. What are the effectiveness and
harms of different frequencies and
modalities for post-treatment
surveillance strategies after initial
treatment of stages I–III squamous cell
anal cancer?
For all KQs, do the outcomes differ by
patient characteristics such as age, sex,
immunocompromised status, or other
characteristics associated with health
inequities (such as race/ethnicity)?
E:\FR\FM\05SEN1.SGM
05SEN1
60682
Federal Register / Vol. 88, No. 170 / Tuesday, September 5, 2023 / Notices
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING)
Inclusion
Population:
All KQ ..............
Exclusion
Adults with stages I–III squamous cell anal cancer (anal canal and anal
margin).
Patient characteristics such as age, sex, immunocompromised status,
or other characteristics associated with health inequities (such as
race/ethnicity).
....................................................................................................................
Interventions:
KQ1 .................
KQ2 .................
KQ3 .................
KQ4 .................
KQ5 .................
KQ6 .................
Comparison:
KQ1 .................
KQ2 .................
KQ3 .................
KQ4 .................
KQ5: ................
KQ6 .................
Alone or in combination as neoadjuvant/adjuvant or as induction/maintenance:.
• Surgery, radiation therapy, or chemotherapy ........................................
Different modalities of radiation therapy such as, but not limited to,
IMRT, proton radiation therapy, and Brachytherapy boost.
Radiation therapy; varying: .......................................................................
• Doses .....................................................................................................
• Target (primary and nodal) volumes .....................................................
• Fractionation schema.
• Chemotherapy and radiation therapy combinations (e.g., 5Fluorouracil, Mitomycin-C, Cisplatin).
• Variations in dose of: .............................................................................
Æ Radiation therapy ...................................................................................
Æ Chemotherapy.
Immunotherapy (e.g., pembrolizumab, nivolumab).
Post-treatment surveillance strategies: .....................................................
• Frequency.
• Modalities (e.g., MRI, PET scans, biopsy, DRE, anoscopy, flexible
sigmoidoscopy).
• Strategies for surveillance post non-initial treatment.
Alone or in combination as neoadjuvant/adjuvant or as induction/maintenance:.
• Surgery, radiation therapy, or chemotherapy ........................................
Comparators for different modalities of radiation therapy such as, but
not limited to, 3–D CRT, photon or electron radiation therapy, and external beam radiation therapy boost.
Radiation therapy; varying: .......................................................................
• Doses .....................................................................................................
• Target (primary and nodal) volumes .....................................................
• Fractionation schema.
• Chemotherapy and radiation therapy combinations (e.g., 5Fluorouracil, Mitomycin-C, Cisplatin).
• Variations in dose ..................................................................................
Æ Radiation therapy ...................................................................................
Æ Chemotherapy.
Other treatment (e.g., chemotherapy, radiation therapy, chemotherapy +
radiation therapy).
Post-treatment surveillance strategies: .....................................................
ddrumheller on DSK120RN23PROD with NOTICES1
• Frequency ..............................................................................................
• Modalities (e.g., MRI, PET scans, biopsy, DRE, anoscopy, flexible
sigmoidoscopy).
Outcomes:
All KQ ..............
VerDate Sep<11>2014
•
•
•
•
•
•
•
•
•
Adults with:
• Stage IV anal cancer.
• Lower rectal cancer that has spread to the
anal canal.
• Non-squamous cell anal cancer (e.g.,
adenocarcinomas, undifferentiated cancer).
Studies including mixed populations with
Stages I–IV squamous cell anal cancer which
contain 20% or greater proportion of stage IV
squamous cell anal cancer.
• Reconstructive surgery.
• Palliative therapy (includes chemotherapy
with palliative intent).
• Treatment for premalignant lesions.
• Palliative therapy.
• Palliative therapy.
• Palliative therapy.
• Screening for primary prevention.
• Initial staging.
• Reconstructive surgery.
• Palliative therapy (includes chemotherapy
with palliative intent).
• Treatment for premalignant lesions.
• Palliative therapy.
• Palliative therapy.
• Palliative therapy.
• Screening for primary prevention.
• Initial staging.
• Strategies for surveillance post non-initial
treatment.
Overall survival.
Disease specific survival.
Disease-free survival (including persistence, recurrence, or relapse).
Colostomy-free survival.
Local control.
Complete clinical response.
Salvage rate.
Sphincter preservation.
Health-related quality of life.
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Federal Register / Vol. 88, No. 170 / Tuesday, September 5, 2023 / Notices
60683
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING)—Continued
Inclusion
Exclusion
• Treatment breaks (frequency or duration), treatment discontinuation,
interruptions, or median treatment days.
• Bleeding per rectum.
• Functional outcomes (e.g., fecal or urinary incontinence, erectile dysfunction, sexual dysfunction, use of vaginal dilators).
• Harms of treatment including acute and late toxicity (e.g.,
myelosuppression, gastrointestinal toxicity, such as diarrhea, vomiting, and bowel obstruction, secondary malignancy, radiation dermatitis, radiation proctitis, radiation cystitis, pelvic insufficiency fractures,
vaginal stenosis).
Timing:
All KQ ..............
Setting:
All KQ ..............
Study design:
All KQ ..............
No restrictions on duration of treatments or follow-up.
Cancer care settings.
Randomized controlled trials, non-randomized controlled trials, observational cohort with concurrent comparator, interrupted time-series, and
other quasi-experimental designs using appropriate analytic techniques.
Case reports, case series, commentaries,
cross-sectional studies, reviews, qualitative
studies, studies with sample size less than 30
patients (or less than 15 per treatment group/
arm), non-randomized studies with unspecified or poorly defined intervention/treatment
protocol (e.g., lack of names of chemotherapy agents used), non-randomized studies with analytic techniques that don’t allow
drawing causal inferences.
Abbreviations: 3–D CRT= three-dimensional conformal radiation therapy; DRE= digital rectal exam; IMRT=intensity-modulated radiation therapy; KQ=key question; MRI= magnetic resonance imaging; PET= positron emission tomography; RCT=randomized controlled trial; VMAT= Volumetric modulated arc therapy.
Marquita Cullom,
Associate Director.
[FR Doc. 2023–19031 Filed 9–1–23; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:
This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the proposed
information collection project ‘‘Use of
Open-Ended Responses to Explore
Disparities in Patient Experience.’’ This
proposed information collection was
previously published in the Federal
Register on June 27th, 2023, and
allowed 60 days for public comment.
AHRQ received no substantive
comments from members of the public.
The purpose of this notice is to allow an
additional 30 days for public comment.
DATES: Comments on this notice must be
received by October 5, 2023.
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:02 Sep 01, 2023
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. Copies of the proposed
collection plans, data collection
instruments, and specific details on the
estimated burden can be obtained from
the AHRQ Reports Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
email at doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
Jkt 259001
Proposed Project
Use of Open-Ended Responses To
Explore Disparities in Patient
Experience
The Consumer Assessment of
Healthcare Providers and Systems
(CAHPS) program, which is sponsored
by AHRQ, has the purpose of advancing
the scientific understanding of the
patient experience of care, including the
development and testing of new surveys
and/or approaches to data collection to
promote or improve the collection of
consumer reports and evaluations of
their experiences with health care.
This Project has the following goals:
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Sfmt 4703
(1) Use open-ended (narrative)
responses to provide context, detail, and
understanding regarding observed
differences in patient experience based
on race, ethnicity, gender, and preferred
language.
(2) Use Clinician and Group-CAHPS
Narrative Item Set (NIS)-generated
narrative data to examine potential
algorithmic bias in natural language
programs (NLP) that could potentially
be used to code large quantities of
narrative data.
(3) Where algorithmic bias is
uncovered, use this analysis to identify
adjustments that can be applied to both
the input for these programs or the
outputs.
This project is being conducted by
AHRQ through its contractor, the RAND
Corporation, pursuant to AHRQ’s
statutory authority to conduct and
support research on health care and on
systems for the delivery of such care,
including activities with respect to the
quality, effectiveness, efficiency,
appropriateness, and value of healthcare
services and with respect to quality
measurement and improvement. 42
U.S.C. 299a(a)(1) and (2).
Method of Collection
To achieve the goals of this project the
following data collections will be
implemented:
Online survey: Data will be collected
from a sample of 4,998 survey
E:\FR\FM\05SEN1.SGM
05SEN1
]]>Agencies
[Federal Register Volume 88, Number 170 (Tuesday, September 5, 2023)]
[Notices]
[Pages 60681-60683]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19031]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Treatment of Stage I-
III Squamous Cell Anal Cancer
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for supplemental evidence and data submissions.
-----------------------------------------------------------------------
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 Treatment of
Stage I-III Squamous Cell Anal Cancer, 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 October 5, 2023.
ADDRESSES:
Email submissions: [email protected].
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: [email protected].
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 Treatment of Stage I-
III Squamous Cell Anal Cancer. 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 Treatment of Stage I-III Squamous Cell Anal Cancer. The
entire research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/anal-cancer-treatment/protocol.
This is to notify the public that the EPC Program would find the
following information on Treatment of Stage I-III Squamous Cell Anal
Cancer helpful:
[ssquf] 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.
[ssquf] 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.
[ssquf] 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.
[ssquf] 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://www.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. What are the effectiveness and harms of different modalities
of initial treatment for stages I-III squamous cell anal cancer?
KQ 2. What are the effectiveness and harms of different modalities
of radiation therapy for initial treatment of stages I-III squamous
cell anal cancer?
KQ 3. What are the effectiveness and harms of different radiation
therapy doses, volumes, and fractionation schema for initial treatment
of stage I-III squamous cell anal cancer?
KQ 4. What are the effectiveness and harms of different
combinations of chemotherapy and radiation therapy, and dose de-
escalation or dose escalation for initial treatment of stages I-III
squamous cell anal cancer?
KQ 5. What are the effectiveness and harms of immunotherapy for
initial treatment of stages I-III squamous cell anal cancer?
KQ 6. What are the effectiveness and harms of different frequencies
and modalities for post-treatment surveillance strategies after initial
treatment of stages I-III squamous cell anal cancer?
For all KQs, do the outcomes differ by patient characteristics such
as age, sex, immunocompromised status, or other characteristics
associated with health inequities (such as race/ethnicity)?
[[Page 60682]]
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and Setting)
----------------------------------------------------------------------------------------------------------------
Inclusion Exclusion
----------------------------------------------------------------------------------------------------------------
Population:
All KQ......................... Adults with stages I-III squamous cell Adults with:
anal cancer (anal canal and anal margin). Stage IV anal cancer.
Lower rectal cancer
that has spread to the anal
canal.
Non-squamous cell anal
cancer (e.g., adenocarcinomas,
undifferentiated cancer).
Patient characteristics such as age, sex,
immunocompromised status, or other
characteristics associated with health
inequities (such as race/ethnicity).
.......................................... Studies including mixed
populations with Stages I-IV
squamous cell anal cancer
which contain 20% or greater
proportion of stage IV
squamous cell anal cancer.
Interventions:
KQ1............................ Alone or in combination as neoadjuvant/ Reconstructive
adjuvant or as induction/maintenance:. surgery.
Surgery, radiation therapy, or Palliative therapy
chemotherapy. (includes chemotherapy with
palliative intent).
Treatment for
premalignant lesions.
KQ2............................ Different modalities of radiation therapy Palliative therapy.
such as, but not limited to, IMRT, proton
radiation therapy, and Brachytherapy
boost.
KQ3............................ Radiation therapy; varying:............... Palliative therapy.
Doses............................
Target (primary and nodal)
volumes.
Fractionation schema.............
KQ4............................ Chemotherapy and radiation Palliative therapy.
therapy combinations (e.g., 5-
Fluorouracil, Mitomycin-C, Cisplatin).
Variations in dose of:...........
[cir] Radiation therapy...................
[cir] Chemotherapy........................
KQ5............................ Immunotherapy (e.g., pembrolizumab,
nivolumab).
KQ6............................ Post-treatment surveillance strategies:... Screening for primary
prevention.
Frequency........................
Modalities (e.g., MRI, PET scans, Initial staging.
biopsy, DRE, anoscopy, flexible
sigmoidoscopy).
Strategies for surveillance post
non-initial treatment.
Comparison:
KQ1............................ Alone or in combination as neoadjuvant/ Reconstructive
adjuvant or as induction/maintenance:. surgery.
Palliative therapy
(includes chemotherapy with
palliative intent).
Surgery, radiation therapy, or Treatment for
chemotherapy. premalignant lesions.
KQ2............................ Comparators for different modalities of Palliative therapy.
radiation therapy such as, but not
limited to, 3-D CRT, photon or electron
radiation therapy, and external beam
radiation therapy boost.
KQ3............................ Radiation therapy; varying:............... Palliative therapy.
Doses............................
Target (primary and nodal)
volumes.
Fractionation schema.............
KQ4............................ Chemotherapy and radiation Palliative therapy.
therapy combinations (e.g., 5-
Fluorouracil, Mitomycin-C, Cisplatin).
Variations in dose...............
[cir] Radiation therapy...................
[cir] Chemotherapy........................
KQ5:........................... Other treatment (e.g., chemotherapy, ...............................
radiation therapy, chemotherapy +
radiation therapy).
KQ6............................ Post-treatment surveillance strategies:... Screening for primary
prevention.
Initial staging.
Strategies for
surveillance post non-initial
treatment.
Frequency........................
Modalities (e.g., MRI, PET scans,
biopsy, DRE, anoscopy, flexible
sigmoidoscopy).
Outcomes:
All KQ......................... Overall survival.................
Disease specific survival........
Disease-free survival (including
persistence, recurrence, or relapse).
Colostomy-free survival..........
Local control....................
Complete clinical response.......
Salvage rate.....................
Sphincter preservation...........
Health-related quality of life...
[[Page 60683]]
Treatment breaks (frequency or
duration), treatment discontinuation,
interruptions, or median treatment days.
Bleeding per rectum..............
Functional outcomes (e.g., fecal
or urinary incontinence, erectile
dysfunction, sexual dysfunction, use of
vaginal dilators).
Harms of treatment including
acute and late toxicity (e.g.,
myelosuppression, gastrointestinal
toxicity, such as diarrhea, vomiting, and
bowel obstruction, secondary malignancy,
radiation dermatitis, radiation
proctitis, radiation cystitis, pelvic
insufficiency fractures, vaginal
stenosis).
Timing:
All KQ......................... No restrictions on duration of treatments
or follow-up.
Setting:
All KQ......................... Cancer care settings......................
Study design:
All KQ......................... Randomized controlled trials, non- Case reports, case series,
randomized controlled trials, commentaries, cross-sectional
observational cohort with concurrent studies, reviews, qualitative
comparator, interrupted time-series, and studies, studies with sample
other quasi-experimental designs using size less than 30 patients (or
appropriate analytic techniques. less than 15 per treatment
group/arm), non-randomized
studies with unspecified or
poorly defined intervention/
treatment protocol (e.g., lack
of names of chemotherapy
agents used), non-randomized
studies with analytic
techniques that don't allow
drawing causal inferences.
----------------------------------------------------------------------------------------------------------------
Abbreviations: 3-D CRT= three-dimensional conformal radiation therapy; DRE= digital rectal exam; IMRT=intensity-
modulated radiation therapy; KQ=key question; MRI= magnetic resonance imaging; PET= positron emission
tomography; RCT=randomized controlled trial; VMAT= Volumetric modulated arc therapy.
Marquita Cullom,
Associate Director.
[FR Doc. 2023-19031 Filed 9-1-23; 8:45 am]
BILLING CODE 4160-90-P
