Critical analysis and evaluation frameworks

¶ … Scientific Admissibility and Merit of Published Articles

CRITICAL APPRAISAL FORM

Section a: Reference of Article

Eric a. Macklin, Peter M. Wayne, Leslie a. Kalish, Peter Valaskatgis, James Thompson, May C.M. Pian-Smith, Qunhao Zhang, Stephanie Stevens, Christine Goertz, Ronald J. Prineas, Beverly Buczynski, Randall M. Zusman

Stop Hypertension with the Acupuncture Research Program (SHARP): Results of a Randomized, Controlled Clinical Trial

Journal: Hypertension: Journal of the American Heart Association

Volume and Page Numbers: Vol. 48;

General Methodological Issues

For each criterion, check the appropriate box, according to how you think it is addressed: (Y=yes, S=substandard, N=No, NA=Not applicable, NQ=Not Qualified to Assess)

Criteria

NQ

Comments priori hypothesis clearly stated

Source population identified

Inclusion criteria described and appropriate (same in all groups)

Exclusion criteria described and appropriate (same in all groups)

Number of excluded or refusal (before study) reported

Withdrawals (during study) reported, explained, and reasonable

Withdrawals equal in groups

Sample size preplanned to provide adequate statistical power

Statistical analysis appropriate

Adjustment for multiple comparisons

Adjustment for important values

Results verifiable from raw data

Section G: Brief Summary of Paper: Descriptive information (short sentences)

Treatments being compared:

Check: [ two treatment arms [ great than two treatment arms

Design:

Check: [x] efficacy trial [ effectiveness trial

Method of assignment to treatment group: Random, stratified according to use of antihypertensives in previous six months.

Outcomes ascertained: BP increased modestly between measurements taken before and after an acupuncture session (by 2.1/0.8 mm Hg for a participant with pre-acupuncture BP of 143/88 mm Hg). No significant difference was found in the immediate effect of active vs. sham acupuncture. The risk of developing BP levels that required initiation of antihypertensive drugs did not differ significantly among participants randomly assigned to the 3 treatment groups. During follow-up, 2 STD participants experienced hypertensive urgencies, and 1 CNTL participant experienced congestive heart failure. No deaths occurred. The risk of any (n=98) or study-related (n=50) adverse events did not differ among treatment groups.

Main Source of Subjects: Subjects were recruited from outpatient clinics, referrals from Boston-area physicians, advertising in local periodicals and public transportation, and through mass mailings.

Inclusion Criteria: Untreated blood pressure (BP) of 140/90 to 179/109 mm Hg. No acupuncture in the previous six months.

Exclusion Criteria: Less than 18 years of age. Medical contraindications to acupuncture. Those individuals lacking follow-up data were subsequently excluded.

Main Source of Data: TCM individualized (IND), TCM standardized (STD), or control (CNTL) acupuncture

Duration of follow-up: 35 to 65 days

Number considered for enrollment: 424

Number enrolled: 192

Number included in analysis: 188

Statistic methods: linear mixed model; subgroup analyses for age, race, gender, baseline BP, history of antihypertensive use, obesity, primary TCM diagnoses

Other relevant information:

Section H: Specific Methodological Issues

For each criterion, check the appropriate box, according to how you think it is addressed: (Y=yes, S=substandard, N=No, NA=Not applicable, NQ=Not Qualified to Assess); cite page number for key comments.

Criteria

NQ

Comments

Randomization properly done

Baseline comparability reported

Same data collection for all arms

Subjects blinded to treatment assignment

Care givers blinded to treatment assignment

Treatments clearly described

Co intervention monitored

Compliance monitored and equal in all groups

Side effects assessed

Outcomes defined, measurable and valid

Blind assessment of outcomes

Section I: Author's key results and conclusions

Including quantitative estimates, e.g. relative risk, reduction in risk, confidence intervals, and p values)

The average magnitude of BP declines achieved by participants was no greater than the magnitude of decrease observed in the placebo arms of 7 pharmaceutical trials analyzed by the Individual Data Analysis of Antihypertensive Intervention trials (INDANA) research committee. Results suggest that 6 weeks of twice-weekly sessions of fully individualized TCM acupuncture are unlikely to achieve clinically meaningful reductions in SBP or DBP for the average patient with mild-to-moderate hypertension relative to invasive sham acupuncture.

Section S: Conclusions and Assessment of the Article

Strengths of Paper