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Short‐course oral steroids as an adjunct therapy for chronic rhinosinusitis

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view the current version 26 April 2016

Appendices

Appendix 1. CENTRAL search strategy

#1 MeSH descriptor: [Sinusitis] explode all trees

#2 MeSH descriptor: [Rhinitis] this term only

#3 MeSH descriptor: [Rhinitis, Atrophic] this term only

#4 MeSH descriptor: [Rhinitis, Vasomotor] this term only

#5 MeSH descriptor: [Paranasal Sinus Diseases] this term only

#6 MeSH descriptor: [Paranasal Sinuses] explode all trees

#7 rhinosinusitis or nasosinusitis or pansinusitis or ethmoiditis or sphenoiditis

#8 kartagener* near syndrome*

#9 inflamm* near sinus*

#10 (maxilla* or frontal*) near sinus*

#11 #1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9 or #10

#12 MeSH descriptor: [Chronic Disease] explode all trees

#13 MeSH descriptor: [Recurrence] explode all trees

#14 chronic or persis* or recurrent*

#15 #12 or #13 or #14

#16 #11 and #15

#17 CRSsNP

#18 (sinusitis or rhinitis) near (chronic or persis* or recurrent*)

#19 #16 or #17 or #18

#20 MeSH descriptor: [Nasal Polyps] explode all trees

#21 MeSH descriptor: [Nose] explode all trees

#22 MeSH descriptor: [Nose Diseases] explode all trees

#23 #21 or #22

#24 MeSH descriptor: [Polyps] explode all trees

#25 #23 and #24

#26 (nose or nasal or rhino* or rhinitis or sinus* or sinonasal) near (papilloma* or polyp*)

#27 rhinopolyp* or CRSwNP

#28 #19 or #20 or #25 or #26 or #27

#29 MeSH descriptor: [Steroids] explode all trees

#30 MeSH descriptor: [Adrenal Cortex Hormones] explode all trees

#31 MeSH descriptor: [Glucocorticoids] explode all trees

#32 MeSH descriptor: [Anti‐Inflammatory Agents] explode all trees

#33 MeSH descriptor: [Anti‐Inflammatory Agents, Non‐Steroidal] explode all trees

#34 #32 not #33

#35 steroid* or glucocorticoid* or corticosteroid* or glucosteroid* or cyclocosteroid*

#36 beclomethasone or beclometasone or beclamet or beclocort or becotide

#37 betamethasone or betadexamethasone or flubenisolone or celeston* or cellestoderm or betnelan or oradexon

#38 dexamethasone or dexameth or dexone or dexametasone or decadron or dexasone or hexadecadron or hexadrol or methylfluorprednisolone or millicorten

#39 flunisolide or fluticasone or hydrocortisone or cortisol or cortifair or cortril or hyrocortone or cortef or epicortisol or efcortesol or Cortisone

#40 methylprednisolone or medrol or metripred or urbason

#41 mometasone or prednisolone or precortisyl or deltacortril or deltastab or prednesol or deltasone or prednisone or cortan or liquid next pred or meticorten

#42 paramethasone or triamcinolone or aristocort or volon or atolone or kenacort or orasone or panasol or prednicen

#43 corticoid* or betamethason* or betamethasone or hydrocortison* or celesto* or dexamethason* or hexadecadrol or budesonid* or horacort or pulmicort or rhinocort or methylfluorprednisolone or flunisolid* or nasalide or fluticason* or flonase or flounce or mometason* or nasonex or triamclinolon* or nasacort or tri next nasal or aristocort or Ciclesonide

#44 #29 or #30 or #31 or #34 or #35 or #36 or #37 or #38 or #39 or #40 or #41 or #42 or #43

#45 #28 and #44

Appendix 2. Data extraction form

REF ID:

Study title:

Date of extraction:

Extracted by:

General comments/notes (internal for discussion):

Flow chart of trial

Group A (Intervention)

Group B (Comparison)

No. of people screened

No. of participants randomised ‐ all

No. randomised to each group

No. receiving treatment as allocated

No. not receiving treatment as allocated

‐ Reason 1

‐ Reason 2

No. dropped out

(no follow‐up data for any outcome available)

No. excluded from analysis1 (for all outcomes)

‐ Reason 1

‐ Reason 2

1This should be the people who received the treatment and were therefore not considered 'drop‐outs' but were excluded from all analyses (e.g. because the data could not be interpreted or the outcome was not recorded for some reason).

Information to go into 'Characteristics of included studies' table

Methods

X arm, double/single/non‐blinded, [multicentre] parallel‐roup/cross‐over/cluster‐RCT, with x duration of treatment and x duration of follow‐up

Participants

Location: country, no of sites etc.

Setting of recruitment and treatment:

Sample size:

  • Number randomised: x in intervention, y in comparison

  • Number completed: x in intervention, y in comparison

Participant (baseline) characteristics:

  • Age:

  • Gender:

  • Main diagnosis: [as stated in paper]

  • Polyps status: x % with polyps/no information [add info on mean polyps score if available]

  • Previous sinus surgery status: [x% with previous surgery]

  • Previous courses of steroids: [add info on mean number of courses if available]

  • Other important effect modifiers, if applicable (e.g. aspirin sensitivity, comorbidities of asthma):

Inclusion criteria:[state diagnostic criteria used for CRS, polyps score if available]
Exclusion criteria:

Interventions

Intervention (n = x): drug name, method of administration, dose per day/frequency of administration, duration of treatment

Comparator group (n = y):

Use of additional interventions (common to both treatment arms):

Outcomes

Outcomes of interest in the review:

Primary outcomes:

  • Health‐related quality of life, disease‐specific

  • Disease severity symptom score

  • Significant adverse effects: [review specific]

Secondary outcomes:

  • Health‐related quality of life, generic

  • [Other review specific, pre‐specified adverse events]

  • [Other review specific, pre‐specified adverse events]

  • Endoscopy (polyps size or overall score)

  • CT scan

Other outcomes reported by the study:

  • [List outcomes reported but not of interest to the review]

Funding sources

'No information provided'/'None declared'/State source of funding

Declarations of interest

'No information provided'/'None declared'/State conflict

Notes

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Quote: "…"

Comment:

Allocation concealment (selection bias)

Quote: "…"

Comment:

Blinding of participants and personnel (performance bias)

Quote: "…"

Comment:

Blinding of outcome assessment (detection bias)

Quote: "…"

Comment:

Incomplete outcome data (attrition bias)

Quote: "…"

Comment:

Selective reporting (reporting bias)

Quote: "…"

Comment:

Other bias (see section 8.15)

Insensitive/non‐validated instrument?

Quote: "…"

Comment:

Other bias (see section 8.15)

Quote: "…"

Comment:

Findings of study: continuous outcomes

Results (continuous data table)

Outcome

Group A

Group B

Other summary stats/Notes

Mean

SD

N

Mean

SD

N

Mean difference (95% CI), P values etc.

Disease specific HRQL

(instrument name/range)

Time point:

Generic HRQL

(instrument name/range)

Time point:

Symptom score (overall)

(instrument name/range)

Time point:

Added total ‐ if scores reported separately for each symptom (range)

Time point:

Nasal blockage/obstruction/congestion

(instrument name/range)

Nasal discharge

(instrument name/range)

Facial pain/pressure

(instrument name/range)

Smell (reduction)

(instrument name/range)

Headache

(instrument name/range)

Cough (in children)

(instrument name/range)

Polyp size

(instrument name/range)

CT score

(instrument name/range)

Comments:

Results (dichotomous data table)

Outcome

Applicable review/intervention

Group A

Group B

Other summary stats/notes

No. of people with events

No. of people analysed

No. of people with events

No. of people analysed

P values, RR (95% CI), OR (95% CI)

Epistaxis/nose bleed

INCS

Saline irrigation

Local irritation (sore throat, oral thrush, discomfort)

INCS

Saline irrigation

Osteoporosis (minimum 6 months)

INCS

Stunted growth (children, minimum 6 months)

INCS

Can also be measured as average height

Mood disturbances

OCS

Gastrointestinal disturbances

(diarrhoea, nausea, vomiting, stomach irritation)

OCS

Antibiotics

Insomnia

OCS

Osteoporosis (minimum 6 months)

INCS

OCS

Discomfort

Saline irrigation

Skin irritation

Antibiotics

Anaphylaxis or other serious allergic reactions such as Stevens‐Johnson

Antibiotics

Comments: