title: Influence of Study Design on Outcomes Following Reflexology Massage: An Integrative and Critical Review of Interventional Studies.
abstract: BACKGROUND
  Interpretation of the efficacy of reflexology is hindered by inconsistent research designs and complicated by professional views that criteria of randomized controlled trials (RCTs)are not ideal to research holistic complementary and alternative medicine practice. The influence of research designs on study outcomes is not known. This integrative review sought to evaluate this possibility.
  
  
  METHODS
  Thirty-seven interventional studies (2000-2014) were identified; they had RCT or non-RCT design and compared reflexology outcomes against a control/comparison group. Viability of integrating RCT and non-RCT studies into a single database was first evaluated by appraisal of 16 reporting fields related to study setting and objectives, sample demographics, methodologic design, and treatment fidelity and assessment against Jadad score quality criteria for RCTs. For appraisal, the database was stratified into RCT/non-RCT or Jadad score of 3 or more or less than 3. Deficits in reporting were identified for blind assignment of participants, dropout/completion rate, and School of Reflexology. For comparison purposes, these fields were excluded from subsequent analysis for evidence of association between design fields and of fields with study outcomes.
  
  
  RESULTS
  Thirty-one studies applied psychometric tools and 20 applied biometric tools (14 applied both). A total of 116 measures were used. Type of measure was associated with study objectives (p < 0.001; chi-square), in particular of psychometric measures with a collated "behavioral/cognitive" objective. Significant outcomes were more likely (p < 0.001; chi-square) for psychometric than for biometric measures. Neither type of outcome was associated with choice of RCT or non-RCT method, but psychometric responses were associated (p = 0.007) with a nonmassage control strategy.
  
  
  CONCLUSIONS
  The review supports psychometric responses to reflexology when study design uses a nonmassage control strategy. Findings suggest that an evaluation of outcomes against sham reflexology massage and other forms of massage, as well as a narrower focus of study objective, may clarify whether there is a relationship between study design and efficacy of reflexology.
authors.affiliation: 1 Faculty of Health, Social Care and Education, Anglia Ruskin University , Chelmsford, United Kingdom .
authors.forename: Andrew
authors.initials: A
authors.lastname: McVicar
authors.affiliation: 2 Faculty of Medical Sciences, Anglia Ruskin University , Chelmsford, United Kingdom .
authors.forename: Christina
authors.initials: C
authors.lastname: Greenwood
authors.affiliation: 2 Faculty of Medical Sciences, Anglia Ruskin University , Chelmsford, United Kingdom .
authors.forename: Carol
authors.initials: C
authors.lastname: Ellis
authors.affiliation: 1 Faculty of Health, Social Care and Education, Anglia Ruskin University , Chelmsford, United Kingdom .
authors.forename: Chantelle
authors.initials: C
authors.lastname: LeForis
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D008297:Male; D008405:Massage; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic / Q000592:standards / Q000706:statistics & numerical data; D012107:Research Design / Q000592:standards / Q000706:statistics & numerical data; D016896:Treatment Outcome; D055815:Young Adult