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Glacy J, Putnam K, Godfrey S, et al. Treatments for Seasonal Allergic Rhinitis [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Jul. (Comparative Effectiveness Reviews, No. 120.)

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

Cover of Treatments for Seasonal Allergic Rhinitis

Treatments for Seasonal Allergic Rhinitis [Internet].

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Appendix DData Abstraction Form Elements

Population Form

  • Is the reference about adults, children or pregnant women?
    • Adults
    • Children
    • Pregnant women

Study Characteristics Form

  • First Author (last name, first name)
  • Publication Year
  • Study Location
    • North America
    • Europe
    • Asia
    • Other (specify)
    • Multicontinental
  • Does the reference have a single or multiple sites?
    • Single
    • Multiple
  • Enrollment month, year- XX/XXXX
  • Funding
    • Industry
    • Academia
    • Academia
    • Not reported
    • Other
  • Were author industry relationships disclosed/identified?
    • Yes
    • No
    • Not Reported
  • Study Design
    • RCT
    • Quasi-RCT
    • Controlled (non-randomized) clinical trial
    • Population-based cohort study
    • Case-control study
    • SR/MA
  • Intervention N:
    • Total number of patients randomized:
    • Total number of patients analyzed:
  • SAR diagnosis objectively confirmed?
    • Yes
    • No
  • Inclusion criteria:
    • Minimum SAR severity:
    • Minimum SAR duration:
    • Both:
  • Exclusion criteria:
    • SAR medication restrictions
    • Other medication restrictions
    • Chronic asthma
    • Immunotherapy
    • Pregnancy
    • Respiratory infection
    • Anatomical deformities
    • Sleep apnea
    • Other:
  • Other symptom-relieving medications allowed?
    • Yes
    • No
  • Duration of treatment (weeks)
  • Duration of follow-up (weeks)
    • Number of weeks
    • Not reported
  • Were pollen counts measured
    • Yes
    • No
  • Blinding
    • Patient
    • Assessor
    • Inadequate patient blinding
    • Inadequate assessor blinding
    • Open-label trial (not blinded)
    • Not reported
  • Was a VAS scale used?
  • Interval NSS definitions
    • Mild
    • Moderate
    • Severe
  • Total nasal symptom scale used
    • Sum
    • Mean
  • TNSS daily maximum score

Group Characteristics Form

  • Group
    • Group One
    • Group Two
    • Group Three
    • Group Four
  • Component 1
    • Drug class
      • Intranasal corticosteroid
      • Selective antihistamine, oral
      • Selective antihistamine, nasal
      • Non-selective antihistamine, oral
      • Intranasal anticholinergic
      • Intranasal mast cell stabilizer
      • Oral decongestant
      • Intranasal decongestant
      • Oral LRA
      • Nasal saline
    • Drug dose
    • Frequency
    • Total daily dose
  • Component 2
    • Drug class
      • Intranasal corticosteroid
      • Selective antihistamine, oral
      • Selective antihistamine, nasal
      • Non-selective antihistamine, ora
      • Intranasal anticholinergic
      • Intranasal mast cell stabilizer
      • Oral decongestant
      • Intranasal decongestant
      • Oral LRA
      • Nasal saline
    • Drug dose
    • Frequency
    • Total daily dose

Patient Characteristics Form

  • Group
    • Group One
    • Group Two
    • Group Three
    • Group Four
  • Patient population
  • Age
    • Mean
    • Median
    • Range
    • SD
    • IQR
  • % Female- XX.X
  • % Race- XX.X
    • Mean
    • Median
    • Range
    • SD
    • IQR
    • Other
  • Disease duration (years)
    • Mean
    • Median
    • Range
    • SD
    • IQR
    • Other

Symptom Outcomes Form

  • Group
    • Group One
    • Group Two
    • Group Three
    • Group Four
  • Total number of patients randomized:
  • Total number of patients analyzed:
  • Outcome measurement type
    • Reflective
    • Instantaneous
    • AM
    • PM
    • Reflective -AM
    • Reflective -PM
    • Instantaneous -AM
    • Instantaneous -PM
    • Other
      1. Not specified
  • Time Point
    • 2 weeks
    • 3 weeks
    • 4 weeks
    • 2 months
    • 3 months
    • 4 months
    • 6 months
    • Other
    • Not specified
  • Label
    • Endpoint
    • Overall/Mean
    • Relative
    • Interval/Mean
    • Uncertain
  • Outcome
    • NSS, congestion
    • NSS, rhinorrhea
    • NSS, sneezing
    • NSS, nasal itching
    • TNSS
    • Asthma
    • TOSS
    • School performance
    • Other medication/rescue med use
  • Outcome measure
    • Pre Mean (SD)
    • Pre Median (range)
    • Post Mean (SD)
    • Post Median (range)
    • Change Mean (SD)
    • Change 95% CI
  • Cough mentioned?
    • Yes
    • No
  • Adherence assessed?
    • Yes (% adherence)
    • No
  • Are other outcomes available?

Function and Quality of Life Outcomes Form

  • Group
    • Group One
    • Group Two
    • Group Three
    • Group Four
  • QoL outcomes mentioned?
    • Yes
    • No
  • Total number of patients randomized:
  • Total number of patients analyzed:
  • Time Point
    • 2 weeks
    • 3 weeks
    • 4 weeks
    • 2 months
    • 3 months
    • 4 months
    • 6 months
    • Other
    • Not specified
  • Quality of Life outcomes
    • RQLQ
    • Mini-RQLQ
    • Rhinasthma QLQ
    • Nocturnal RQLQ
    • SF-36
    • PGA
    • Epworth
  • Outcome measure
    • Pre Mean (SD)
    • Pre Median (range)
    • Post Mean (SD)
    • Post Median (range)
    • Change Mean (SD)
    • Change 95% CI

Comparisons Form

  • Is a statistical test performed?
    • Yes
    • No
  • Statistical Test
    • Kruskal-Wallis
    • Mann Whitney U
    • ANOVA
    • Wilcoxon rank sum test
    • Chi-square
    • T-test
    • ANCOVA
    • Other
  • Outcome measurement type
    • Reflective
    • Instantaneous
    • AM
    • PM
    • Reflective -AM
    • Reflective -PM
    • Instantaneous -AM
    • Instantaneous -PM
    • Other
    • Not specified
  • Time point
    • Pre
    • 2 weeks
    • 3 weeks
    • 4 weeks
    • 2 months
    • 3 months
    • 4 months
    • 6 months
    • Other
    • Not specified
  • Label
    • Endpoint
    • Overall/Mean
    • Relative
    • Interval/Mean
    • Uncertain
  • Comparison between groups
    • 1 vs. 2
      • p-value
    • 1 vs. 3
      1. p-value
    • 2 vs. 3
      ii.

      p-value

    • Multiple group comparisons
      • p-value
  • Outcome
    • NSS, congestion Mean difference (95% CI)
    • NSS, sneezing Mean difference (95% CI)
    • NSS, rhinorrhea Mean difference (95% CI)
    • NSS, nasal itching Mean difference (95% CI)
    • TNSS
    • Rescue med use Ratio (95% CI)
    • TOSS Mean difference (95% CI)

Function and QoL Comparisons Form

  • Is a statistical test performed?
    • Yes
    • No
  • Statistical Test
    • Kruskal-Wallis
    • Mann Whitney U
    • ANOVA
    • Wilcoxon rank sum test
    • Chi-square
    • T-test
    • ANCOVA
    • Other
  • Time point
    • Pre
    • 2 weeks
    • 3 weeks
    • 4 weeks
    • 2 months
    • 3 months
    • 4 months
    • 6 months
    • Other
    • Not specified
  • Comparison between groups
    • 1 vs. 2
      • p-value
    • 1 vs. 3
      • p-value
    • 2 vs. 3
      • p-value
    • Multiple group comparisons
      • p-value
  • Quality of Life outcomes
    • Test result (95% CI)
    • Mini-RQLQ Test result (95% CI)
    • RQLQ Rhinasthma QLQ Test result (95% CI)
    • Nocturnal RQLQ Test result (95% CI)
    • SF-36 Test result (95% CI)
    • PGA Test result (95% CI)
    • Epworth Test result (95% CI)

Adverse Events Form

  • Group
    • Group One
    • Group Two
    • Group Three
    • Group Four
  • AEs mentioned?
    • Yes
    • No
  • N (number analyzed)
  • Type of adverse event by severity
    • Mild AEs reported -- % XX.X
    • Moderate AEs reported -- % XX.X
    • Severe AEs reported -- % XX.X
    • Unspecified severity AEs reported -- % XX.X
      • Sedation
      • Headache
      • Stinging
      • Dryness
      • Burning
      • Impaired work/school performance
      • Odor abnormalities
      • Bitter aftertaste
      • Hypertension
      • Palpitations
      • Insomnia
      • Anxiety
      • Nosebleeds
      • Rhinitis medicamentosa
      • Increased intraocular pressure
      • Cataract formation
      • Nasal septal atrophy
      • Fungal infection
      • Adrenal suppression
      • Hyperglycemia
      • Bone demineralization/fracture
      • Growth delay in children
      • Traffic accidents
      • Nasal discomfort

Study Quality

RCT Quality Assessment (USPSTF)

  • Power calculation reported?
    • Yes
    • No
  • Assembly of comparable groups
    • Yes
    • No
  • Maintenance of comparable groups (includes attrition, crossovers, adherence, and contamination)
    • Yes
    • No
    • Uncertain
  • Minimal loss to followup (<20% each treatment arm)
    • Yes
    • No
  • Interventions comparable/ clearly defined
    • Yes
    • No
    • Uncertain
  • All important outcomes considered
    • Yes
    • No
  • Appropriate analysis of results (adjustment for potential confounders and intention-to-treat analysis)
    • Yes
    • No
  • Overall Rating
    • Good
    • Fair
    • Poor

AE Reporting Quality Assessment, McMaster

  • Were the harms pre-defined using standardized or precise definitions?
    • Yes
    • No
    • Uncertain
  • Were serious events precisely defined?
    • Yes
    • No
    • Uncertain
  • Were severe events precisely defined?
    • Yes
    • No
    • Uncertain
  • Was the mode of harms collection specified as active?
    • Yes
    • No
    • Uncertain
  • Was the mode of harms collection specified as passive?
    • Yes
    • No
    • Uncertain
  • Did the study specify who collected the harms?
    • Yes
    • No
    • Uncertain
  • Did the study specify the training or background of who ascertained the harms?
    • Yes
    • No
    • Uncertain
  • Did the study specify the timing and frequency of collection of the harms?
    • Yes
    • No
    • Uncertain
  • Did the author(s) use standard scale(s) or checklist(s) for harms collection?
    • Yes
    • No
    • Uncertain
  • Did the authors specify if the harms reported encompass all the events collected or a selected sample?
    • Yes
    • No
    • Uncertain
  • Was the number of participants that withdrew or were lost to follow-up specified for each study group?
    • Yes
    • No
    • Uncertain
  • Was the total number of participants affected by harms specified for each study arm?
    • Yes
    • No
    • Uncertain
  • Did the author(s) specify the number for each type of harmful event for each study group?
    • Yes
    • No
    • Uncertain
  • Did the author(s) specify the type of analyses undertaken for harms data?
    • Yes
    • No
    • Uncertain

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