Appendix F

Article Quality Assessment Form

 	TREATMENT OF COEXISTING GLAUCOMA AND CATARACT

					QUALITY ASSESSMENT FORM

1.	Article ID: _______________    2.  First author: ____________________________________________

3a.	Primary Reviewer (initials): _______________  3b.	Secondary Reviewer (initials): _______________

4.	BASIC FEATURES (circle if answer is true, circle only one):

	a.	did NOT include human data

	b.	 adults are NOT part of the population

	c.	not in English

	d.	NO original data

	e.	does not address open angle glaucoma or primary angle closure glaucoma.

	f.	was neither a controlled trial nor a case series > 100 eyes

	g.	only addresses ICCE

	h.	only addresses full thickness glaucoma surgery

	i.	meeting abstract

	j.	does not report outcomes relevant to our study questions

	k.	other (specify) ________________________________________

IF ANY OF THE ABOVE ITEMS IS CIRCLED  --  STOP

5.	Focus of study: (Circle letter for all that apply)

	a.  Effect of glaucoma surgery on the development and progression of cataract.	  1 

	b.  Effect of cataract surgery (with or without other procedures/treatments) on long-term IOP control in open angle        glaucoma patients.	2

	c.  Effect of cataract surgery  (with or without other procedures/treatments) on short-term IOP control in open angle        glaucoma patients.	3	 

	d.  Risks and benefits of staged versus combined procedures.	4 

	e.  Risks and benefits of anti-fibrosis agents.	5 

	f.  Risks and benefits of single site versus two site operations.	6 

	g.  Risks and benefits of trabeculectomy versus endoscopic laser versus deep sclerectomy/viscocanulostomy.	7 

	h.  Risks and benefits of nuclear expression or phacoemulsification.	8 

6.	Indicate study design.  (Circle the one letter listed below that describes the study design.)

	a.  Randomized trial 			1	

	b.  Non-randomized controlled trial 	2

	c.  Cohort				3

	d.  Case-control				4

	e.  Cross-sectional			5

	f.   Clinical series			6

	g.  Other (specify type)			7

                If F, “clinical series” is circled -- STOP.

	 REPRESENTATIVENESS OF STUDY POPULATION

			(For each question, indicate your response by circling one letter)			 	

8.	Were the setting and population from which study sample drawn described and dates of study

	reported?

	a.	adequate		(setting AND population described AND start date and end	    2   

					date specified)

	b.	fair			(one or more of these NOT reported OR poor descriptions)	1   

	c.	inadequate		(not specified)							0   	

	d.	not applicable	N/A   

9.	Were detailed inclusion/exclusion criteria provided, so as to allow replication?

	a.	adequate		(detailed description of specific inclusion and exclusion	2   

					criteria OR statement that all consecutive patients enrolled)

	b.	fair			(some description but would be difficult to replicate based on	1   

					information provided OR consecutive patients without

					describing exclusions)

	c.	inadequate		(minimal description or none at all)					0   

	d.	not applicable	N/A   

10.	Was there information on patients excluded/not participating provided?

	a.	adequate		(all reasons for exclusion AND # excluded OR no exclusions)	2   

	b.	fair			(only one of above criteria specified or information not quite	1   

					sufficient to allow replication)

	c.	inadequate		(none of above criteria specified)		0   			

	d.	not applicable	N/A   									

11.	Does the study adequately describe patients’ characteristics at enrollment?

Key Characteristics

prior ocular surgery

race

age

types of glaucoma

severity of glaucoma (e.g., IOP, number of medications, previous treatments)

	a.	excellent		(must include at least 4 of 5 key)   	             2   	

	b.	very good		(3 key)	 1.5   

	c.	good			(2 key)	1   

	d.	fair			(1 key)	0.5   

	e.	poor			(no key characteristics)	0   

	f.	not applicable		N/A 	  

	 BIAS AND CONFOUNDING

	(For each question, indicate your response by circling one letter)

12.	Was assignment of patients to study groups randomized?

	a.	yes		(investigators could not predict assignment)		2   		

	b.	partial		(used DOB, date of admission, hospital #, or alternating scheme for	1   

				assignment  OR did not state method of randomization)		

	c.	not randomized									0   

	d.	unclear											0   

	e.	not applicable										N/A   

13.	Were the key people measuring the major clinical outcomes appropriately masked?

	a.	yes		1   

	b.	no	 0   

	c.	can't tell					0   

14.	Did the groups have any important differences on key factors at baseline?

Key Characteristics

prior ocular surgery

race

age

type of glaucoma

severity of glaucoma (e.g., IOP, number of medications, previous treatments)

	a.	groups equivalent in all key factors 	2   

	b.	groups have a minor difference in 1 factor	1   

	c.	groups have major difference in 1 factor or minor difference in more than 1 factor 							0   

	d.	analysis not done	0   

	e.	not applicable							N/A   

	 DESCRIPTION OF THERAPY

	(For each question, indicate your response by circling one letter)

15.	Was there a complete description of the surgical interventions of interest in the study?

	a.	adequate	 	(protocol could be replicated given the completeness and	2   

					detail  e.g. procedures, drugs, dose, route, duration)

	b.	fair			(some detail but insufficient to ensure replication)	1   

	c.	inadequate		(very little or no detail)							0   

	d.	not applicable										N/A   

16.	Was there an adequate description of postoperative medical regimen and use of antifibrosis agents

	and needling postoperatively?

	a.	complete		(all postoperative treatments discussed in detail, e.g., 5-FU	2   

					dosing, medications and needling described)

	b.	partial			(most postoperative management well described)	1.5   

	c.	fair			(some postoperative management well described)					1   

	d.	can't tell	  0   

	5.	not applicable										N/A   

17.	Were there any differences in ancillary medications/procedures between the treatment groups

	which could have affected results?

	a.	no differences					(essentially the same)		2   					

	b.	minor differences 				(minor differences in protocols)			1   

	c.	major differences or differences not discussed	(e.g. different drugs/procedures	0   

								between groups)

	d.	can’t tell	0   

	e.	not applicable										N/A   

	 OUTCOMES AND FOLLOW-UP

			(For each question, indicate your response by circling one letter)

18.	Were the frequency of evaluations clearly delineated and the length of follow-up comparable?

	a.	both clearly delineated and comparable		2   									

	b.	either clearly delineated or comparable	1   										

	c.	neither/can't tell	0   

	d.	not applicable	N/A   

19.	Were the outcome assessment procedures for IOP objective?

	a.	best			(2 or more Goldman measurements with time of day	2   	

					specified)

	b.	adequate		(at least 1 Goldman measurement)	1   

	c.	fair			(other tonometer)	0.5   

	d.	inadequate		(inadequate or absent)	0   

	e.	not applicable	N/A   

20.         Were the outcome assessment procedures for cataract objective?

	a.	best			(recognized cataract scoring system)	2   

	b.	adequate		(other system)	1   

	c.	fair			(cataract surgery)	0.5   

	d.	inadequate		(inadequate or absent)	0   

	e.	not applicable	N/A   

21.	What was the median length of follow-up (total study)?

	a.	> 24 months		2   							

	b.	13 months-24 months										1.5   

	c.	7 months-12 months										1   

	d.	2 weeks-6 months									1   

	e.	< 1 week 								0.5   

	f.	not stated										0   

	g.	not applicable (use this if study focuses on 24 hour outcomes)				N/A   

	 STATISTICAL QUALITY AND INTERPRETATION

			(For each question, indicate your response by circling one letter)

22.	For primary endpoints, is the magnitude of difference between groups AND an index of

	variability (e.g. test statistic, p value, standard error,  confidence interval) stated?

	a.	adequate		(both reported with index of variability using standard error	2   

					or confidence intervals)

	b.	fair			(both reported with index of variability using only test statistic	1   

					or p value)

	c.	inadequate		(one or both not reported)						0   

	d.	not applicable										N/A   

23.	Were the appropriate analyses and statistical tests performed?

	a.	adequate		(yes for all analyses)							2   

	b.	fair			(yes for only some of the analyses)					1   

	c.	inadequate		(not for any of the analyses or can’t tell)					0   

	d.	not applicable										N/A   

24.	If groups were not comparable at study onset, was there adjustment for potential confounders

	with multivariate or stratified analyses AND were confounders coded in a way to make such

	control adequate?

	a.	adequate		(adjustment done AND confounders appropriately coded)	2   

	b.	fair			(adjustment done BUT confounders not coded appropriately	1   

					OR coding unclear)

	c.	inadequate		(adjustment not done OR comparability not previously	0   

					reported)	

	d.	not applicable										N/A   

25.	Were cross-overs handled appropriately in analysis?

	a.	sensitivity analysis									2   

	b.	by intention to treat									2   

	c.	by ‘treatment received’ analysis only							1   

	d.	by none of the above									0   

	e.	unknown										0   

	f.	not applicable										N/A