Table 3 Critical appraisal of studies meeting the inclusion criteria

Q1.

Was the assignment to treatment groups truly random?

Y

Is the sample representative of patients in the population as a whole?

Y

Was the study based on a random or pseudo-random sample?

N

N

N

N

N

There is congruity between the stated philosophical perspective and the research methodology?

Y

U

Is there a well-defined question?

Y

Y

Q2.

Were participants blinded to treatment?

N

Are the patients at a similar point in the course of their condition?

N

Were the criteria for inclusion in the sample clearly defined?

Y

Y

Y

Y

Y

There is congruity between the research methodology and the research question or objectives?

Y

Y

Is there a comprehensive description of alternatives?

NA

NA

Q3.

Was allocation to treatment groups concealed from the allocator?

Y

Has bias been minimized in relation to selection of cases and controls?

U

Were confounding factors identified and strategies to deal with them stated?

N

Y

Y

N

N

There is congruity between the research methodology and the methods used to collect data?

Y

Y

Are all important and relevant costs and outcomes for each alternative identified?

Y

U

Q4.

Were the outcomes of people who withdrew described and included in the analysis

Y

Are confounding factors identified and strategies to deal with them stated?

Y

Were outcomes assessed using objective criteria?

Y

Y

Y

Y

Y

There is congruity between the research methodology and the representation and analysis of data?

Y

Y

Has clinical effectiveness been established?

NA

Y

Q5

Were those assessing outcomes blind to the treatment allocation?

N

Are outcomes assessed using objective criteria?

Y

If comparisons are being made, were there sufficient descriptions of the groups?

NA

NA

NA

N

NA

There is congruence between the research methodology and the interpretation of results?

Y

Y

Are costs and outcomes measured accurately?

Y

Y

Q6.

Were the control and treatment groups comparable at entry?

Y

Was follow-up carried out over a sufficient time period?

Y

Was follow-up carried out over a sufficient time period?

N

N

N

U

N

There is a statement locating the researcher culturally or theoretically

N

N

Are costs and outcomes valued credibly?

Y

U

Q7.

Were groups treated identically other than for the named interventions?

Y

Were the outcomes of people who withdrew described and included in the analysis?

Y

Were the outcomes of people who withdrew included in the analysis?

N

Y

Y

N

Y

The influence of the researcher on the research, and vice-versa, is addressed

N

N

Are costs and outcomes adjusted for differential timing?

U

Y

Q8.

Were outcomes measured in the same way for all groups?

Y

Were outcomes measured in a reliable way?

U

Were outcomes measured in a reliable way?

Y

Y

Y

U

N

Participants and their voices are adequately represented

Y

Y

Is there an incremental analysis of costs and consequences?

N

Y

Q9.

Were outcomes measured in a reliable way?

Y

Was appropriate statistical analysis used?

Y

Was appropriate statistical analysis used?

Y

Y

Y

NA

Y

The research is ethical according to current criteria or evidence of ethical approval by an appropriate body

Y

Y

Are sensitivity analyses conducted to investigate uncertainty in estimates of cost or consequences?

N

Y

Q10.

Was appropriate statistical analysis used?

Y

Conclusions drawn in the research report appear to flow from the analysis or interpretation of the data

Y

Y

Do study results include all issues of concern to users?

Y

U

Q11.

Are the results generalizable to the setting of interest in the review?

U

U

Quality Rating^a

8/10 Good

6/9 Moderate

4/8 Moderate

6/8 Moderate

6/8 Moderate

2/8 Poor

4/8 Moderate

8/10 Good

7/10 Moderate

5/9 Moderate

6/10 Moderate