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This publication is provided for historical reference only and the information may be out of date.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