Grade table 11, [Question: Should short-acting beta 2...]. - Prevention and Control of Noncommunicable Diseases

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Grade table 11

Question: Should short-acting beta 2 agonists versus placebo or doing nothing be used in COPD patients?

Settings: Community or hospital setting in LMICs

Bibliography: Sestini P et al. (10) (review content assessed up to 13 May 2002)

Quality assessment							Summary of findings					Importance
Quality assessment							No of patients		Effects		Quality
No of studies	Design	Limitations	Inconsistency	Indirectness	Imprecision	Other considerations	Short-acting beta2 agonists	Placebo or doing nothing	Relative (95% CI)	Absolute	Quality
Mortality (follow-up 1–8 weeks; assessed with: number count)
13³^,⁴^,⁵	randomised trials⁶	no serious limitations⁷	no serious inconsistency	very serious⁸	no serious imprecision	reporting bias⁹	–	–	–	–	⊕○○○ VERY LOW	IMPORTANT
13³^,⁴^,⁵	randomised trials⁶	no serious limitations⁷	no serious inconsistency	very serious⁸	no serious imprecision	reporting bias⁹	-	0%	–	–	⊕○○○ VERY LOW	IMPORTANT
QoL (follow-up 1–2 weeks; assessed with: CRQ and change in the oxygen cost diagram)
2¹⁰	randomised trials⁶	serious⁸^,¹¹	serious¹²^,¹³	very serious²^,⁴^,⁵^,⁸	no serious imprecision¹²	reporting bias⁹	–	–	–	–	⊕○○○ VERY LOW	IMPORTANT
2¹⁰	randomised trials⁶	serious⁸^,¹¹	serious¹²^,¹³	very serious²^,⁴^,⁵^,⁸	no serious imprecision¹²	reporting bias⁹	-	0%	–	–	⊕○○○ VERY LOW	IMPORTANT
Breathlessness (follow-up 1–2 weeks; measured with: standard mean difference; better indicated by lower values)
4	randomised trials⁶	serious¹⁴	no serious inconsistency	serious¹²	no serious imprecision	reporting bias¹⁵	94	94⁶	–	SMD 1.33 lower (1.65 to 1.01 lower)	⊕○○○ VERY LOW	IMPORTANT
Wheeze¹⁶ (follow-up 1–8 weeks; measured with: qualitative results reported; better indicated by lower values)
4	randomised trials⁶^,¹⁷	no serious limitations	no serious inconsistency	very serious¹⁸	no serious imprecision	reporting bias¹⁵	0	–	–	mean ranged from 0 to 0 higher	⊕○○○ VERY LOW	IMPORTANT
Cough¹⁹ (follow-up 1–3 weeks; better indicated by lower values)
3²⁰	randomised trials⁶	serious⁸^,¹¹^,¹⁸	no serious inconsistency¹⁹	serious¹¹^,¹⁵^,¹⁸	no serious imprecision	reporting bias⁹ reduced effect for RR >>1 or RR<<1¹⁹	0	–	–	SMD 0.02 lower (1 lower to 0.96 higher)¹⁹	⊕⊕○○ LOW	IMPORTANT
Sputum production (follow-up 2–8 weeks; better indicated by lower values)
5	randomised trials⁶	serious⁶^,¹¹^,¹⁸	no serious inconsistency	serious²^,¹⁵	no serious imprecision	reporting bias⁹	8	8²¹	–	SMD 0.02 higher (0.96 lower to 1 higher)²¹	⊕○○○ VERY LOW	IMPORTANT
Distance walked (follow-up 1–2 weeks; measured with: metres; better indicated by higher values)
4	randomised trials⁶	serious¹¹^,¹⁸	no serious inconsistency	serious²^,¹⁸	no serious imprecision	reporting bias⁹	94	94⁶	–	SMD 0.18 higher (0.11 lower to 0.47 higher)	⊕○○○ VERY LOW	IMPORTANT
Drop-out (follow-up 2–6 weeks; assessed with: number of patients)
5	randomised trials⁶	serious¹¹^,¹⁸	no serious inconsistency	serious²^,¹⁵	no serious imprecision	reporting bias⁹^,¹⁵	22/99 (22.2%)	46/99 (46.5%)	RR 0.49 (0.33 to 0.73)	237 fewer per 1000 (from 125 fewer to 311 fewer)²²	⊕○○○ VERY LOW	IMPORTANT
5	randomised trials⁶	serious¹¹^,¹⁸	no serious inconsistency	serious²^,¹⁵	no serious imprecision	reporting bias⁹^,¹⁵	-	0%	RR 0.49 (0.33 to 0.73)	-	⊕○○○ VERY LOW	IMPORTANT
Serious adverse events (assessed with: number of patients with one or more serious adverse event)
0²³	no evidence available					none	–	–	–	–	–	CRITICAL
0²³	no evidence available					none	-	0%	–	-	–	CRITICAL
Morning PEFR pre-bronchodialator (follow-up mean 2 weeks; measured with: litres per minute; better indicated by higher values)
2	randomised trials⁶	serious¹¹^,¹⁸	no serious inconsistency	serious²^,⁸^,¹⁵	no serious imprecision	reporting bias⁹	67	67	–	MD 4.33 higher (4.64 lower to 13.29 higher)	⊕○○○ VERY LOW	IMPORTANT
Morning PEFR post-bronchodilator (follow-up 2–6 weeks; measured with: litres per minute; better indicated by higher values)
4	randomised trials⁶	serious¹¹	no serious inconsistency	serious²^,⁸^,¹⁵^,¹⁸	no serious imprecision	reporting bias⁹	62	62⁶	–	MD 29.17 higher (0.25 to 58.09 higher)	⊕○○○ VERY LOW	IMPORTANT
Evening PEFR pre-bronchodilator (follow-up mean 2 weeks; measured with: litres per minute; better indicated by higher values)
2	randomised trials⁶	serious¹¹	no serious inconsistency	serious²^,⁸^,¹⁵^,¹⁸	no serious imprecision	reporting bias⁹	67	67⁶	–	MD 5.72 higher (3.34 lower to 14.78 higher)	⊕○○○ VERY LOW	–
Evening PEFR post-bronchodilator (follow-up 2–6 weeks; measured with: litres per minute; better indicated by higher values)
3	randomised trials⁶	serious¹¹	no serious inconsistency	serious²^,⁸^,¹⁸	no serious imprecision	reporting bias⁹	43	43⁶	–	MD 36.75 higher (2.57 to 70.94 higher)	⊕○○○ VERY LOW	IMPORTANT
FEV1 post-bronchodilator (measured with: litres; better indicated by higher values)
6	randomised trials⁶	serious¹¹	no serious inconsistency	serious²^,⁸^,¹⁸	no serious imprecision	reporting bias⁹	74	74	–	MD 0.14 higher (0.04 to 0.25 higher)	⊕○○○ VERY LOW	IMPORTANT
FVC post-bronchodilator (follow-up 1–8 weeks; measured with: litres; better indicated by higher values)
4	randomised trials⁶	serious¹¹	no serious inconsistency	serious²^,⁸^,¹⁸	no serious imprecision	reporting bias⁹	58	58	–	MD 0.30 higher (0.02 to 0.58 higher)	⊕○○○ VERY LOW	IMPORTANT
Incidence of exacerbation
0²²	no evidence available					none	–	–	–	–	–	IMPORTANT
0²²	no evidence available					none	-	0%	–	–	–	IMPORTANT

1: Drug of interest is salbutamol formlations, including tablets, puffers and nebulizers.
2: Population of interest is COPD patients from LMICs; since studies in that population are not available, information from this review will be used.
3: From 13 studies representing nine unique trials.
4: Treatment consisted of isoproterenol in three trials, terbutaline in three trials and salbutamol in three trials.
5: Four trials used nebulizers, others used MDIs or other portable handheld inhaler devices; none used salbutamol tablets.
6: All trials used cross-over design.
7: No study reported mortality data, which may be due to short duration of the study.
8: Studies not done in the populations of LMICs. None of the studies used oral salbutamol.
9: Funnel plot not available. Search is up to 2002.
10: One study reported change in the oxygen cost diagram and one reported CRQ.
11: Cross-over design, carryover effect may impact the true effect size.
12: Two different outcome measures were used and data cannot be compared.
13: Qualitatively, one study reported significant improvement in CRQ; one reported no significant difference in the oxygen cost diagram.
14: No explanation was provided.
15: Authors could not find studies with salbutamol tablets.
16: Poolable data were not available in the studies.
17: In three trials isoproterenol was used; in one trial salbutamol was used. Three trials showed improvement in wheeze; one trial with terbutaline showed no improvement.
18: Studies were done with different drugs; duration varies.
19: One study reported improvement without any data; two studies reported no improvement.
20: Data from one study available for analysis.
21: Only one study (Silins 1985) reported daily sputum production; one study (Wilson 1980) reported morning and evening sputum production; three studies reported qualitative results.
22: Not reported in the review.
23: No study reported.
24: For pre-bronchodilator, no significant difference observed; data not shown here.

From: Annex 4, Grade tables

Cover of Prevention and Control of Noncommunicable Diseases

Prevention and Control of Noncommunicable Diseases: Guidelines for Primary Health Care in Low Resource Settings.

Geneva: World Health Organization; 2012.

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