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. 2019 Aug 6;2019(8):CD012379. doi: 10.1002/14651858.CD012379.pub2

Robinson 2015.

Methods

  • Study design: RCT; 853 assessed for eligibility, 170 randomised

  • Study duration (recruitment): 30 May to 15 July 2014

  • Study follow‐up: 6 weeks
Participants

  • Country: USA

  • Setting: community

  • kidney transplant recipients

  • Number (randomised/completed): intervention group (84/78); control group (86/83)

  • Mean age ± SD (years): intervention group (51 ± 12.5); control group (49 ± 14.2)

  • Sex (M): intervention group (56%); control group (62%)

  • Exclusion criteria: history of skin cancer as self‐reported or noted in their medical record; received education about sun protection or participated in our previous educational sun protection study; experienced kidney rejection; visually impaired; comorbid diseases prevented participation
Interventions

  • Intervention type classification: Education plus reminders

  • eHealth intervention used: tablet application plus reminder emails or text messages


Intervention group

  • Tablet app education

    • Research team gave brief tutorials about how to use tablet

    • Sun protection program delivered on personal tablet computers

    • During the next 5 weeks, 2 reminders provided to intervention group as telephone calls, text messages or emails (depending on participant preference)


Control group

  • Usual care

    • 2‐3 sentences in binder provided at time of transplantation surgery and during summer clinicians gave verbal reminders to wear sunscreen
Outcomes Outcomes measured at baseline and 6 weeks

  • Sun protection behaviours (self‐reported, validated tool)

  • Willingness to use sun protection (self‐reported, validated tool)

  • Knowledge of skin cancer and sun protection (self‐reported, validated tool)

  • Attitudes about developing skin cancer and personal risk (self‐reported, validated tool)

  • Skin pigmentation (clinical dermatologist + trained research coordinators + spectrophotometer)
Notes

  • Additional paper and abstract looking at Health Literacy sub‐group analysis

  • Results stratified by ethnicity

  • Funding source: Supported by R21 CA‐173196 to June K. Robinson, MD, from the National Cancer Institute
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Stratified random blocks using R Core Team
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 Blinding of participants High risk Participants could not have been blinded
Blinding of participants and personnel (performance bias) 
 Blinding of personnel Unclear risk Research co‐ordinators and dermatologist blinded, but may have been broken
Blinding of outcome assessment (detection bias) 
 Objective outcome Low risk Objective measures of pigmentation used
Blinding of outcome assessment (detection bias) 
 Subjective outcomes Low risk Validated self‐reported measures of knowledge, behaviours and attitudes. research personnel assessing skin pigmentation were trained by a clinical dermatologist for the study blinded however this blinding may have been broken and RAs not dermatologists which may question accuracy of their assessment
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 5% loss to follow‐up (9/172)
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement
Other bias High risk Low participation rate ‐ may not be representative; higher participation rates among white people; monetary incentives