KONSİL

Glossary · Statistics

What is sample size?

Sample size is the number of participants or observations a study needs in its analysis to reach its aim. It is mainly calculated either to estimate a quantity with a chosen precision (confidence interval width) or to detect a given difference with adequate power in a hypothesis test.

In a precision-based calculation the aim is, for example, to estimate a prevalence with a chosen precision. Naing et al. (2006) give n = Z² · P · (1 − P) / d² for a single proportion, where Z is the value for the confidence level (1.96 for 95%), P the expected proportion and d the half-width of the confidence interval. According to the same authors n is inversely proportional to the square of the precision (d); on that relationship, halving the half-width quadruples n.

A power-based calculation needs α, the target power, the target difference and, for continuous outcomes, the standard deviation (CONSORT 2010 explanation document). Bland (2009) argues that, if results are presented as confidence intervals, sample size should also rest on confidence interval width rather than power; DELTA2 (2018) notes that precision-based approaches were not then commonly applied.

Whitley and Ball (2002) state that the calculation rests on the number needed in the final analysis, so more subjects must be approached; in their example, 10% refusal and a final sample of 52 require about 58 people, which fits n / (1 − q) for a refusal or drop-out proportion q. Naing et al. advise oversampling by 10% to 20% for non-response, and note that cluster or multistage sampling needs the design effect as a multiplier. CONSORT asks for the attrition allowance to be reported.

Example

In a hypothetical prevalence study with an expected proportion of 20%, 95% confidence (Z = 1.96) and a half-width of ±5%, n = 1.96² × 0.20 × 0.80 / 0.05² = 245.86, so 246 people. If 10% non-response is expected, 246 / 0.90 = 273.33, so 274 people are approached.

A point to watch

According to Bland (2009), researchers might fix the number they can recruit and then present the difference detectable with that sample as the one they want to find; Bland calls this an even less satisfactory path. According to DELTA2, at least one key stakeholder group should regard the target difference as important.

Related terms

Guides and tools

Sources

  1. Statistics review 4: sample size calculations — Critical Care (BioMed Central), 2002
  2. Practical Issues in Calculating the Sample Size for Prevalence Studies — Archives of Orofacial Sciences (Universiti Sains Malaysia), 2006
  3. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials — BMJ, 2010
  4. DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial — BMJ, 2018
  5. The tyranny of power: is there a better way to calculate sample size? — BMJ, 2009