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. 2015 Feb 23;2015(2):CD005610. doi: 10.1002/14651858.CD005610.pub2

Leggett 2004.

Methods Study design: RCT
Aim: to establish whether instant photography allows a correct dermatological diagnosis and reduces the number of patients needing an outpatient appointment with a dermatologist
Unit of allocation: participants
Unit of analysis: participants
Unit of analysis issue: no (participants were the unit of both allocation and analysis)
Stratification: not done
Timing: not reported
Data collection: prospective recording by investigators
Participants Providers: 10 GPs participating from 5 practices (but 20 agreed to participate)
Patients: 136 patients referred to a GP for a dermatological problem
Clinical problem: dermatology referrals
Setting: general practices and a teaching hospital
Country: UK
Interventions Type of intervention: intervention aimed at restructuring the referral process
  • Intervention: Instant photography was taken by GP and was inserted with the referral letter into a sealed numbered envelope. Study group letters were sent directly to the dermatologist: If diagnosis was possible, a letter was sent to the GP with management and appointment for further management if needed; if diagnosis was not possible, an appointment with a dermatologist was booked

  • Control: Instant photography was taken by GP and was inserted with the referral letter into a sealed numbered envelope. Control group envelopes had photographs removed and appointments made as usual


1 camera was placed in each practice, and GPs were trained for 15 minutes in its use
Duration of intervention: not reported
Outcomes Primary:
  • Number of participants needing an initial outpatient appointment with a dermatologist


Secondary:  
  • Number of participants with a photo‐diagnosis who did not need to be seen by a dermatologist

  • Number of participants with a photo‐diagnosis who needed to be seen by a dermatologist

  • Number of participants for whom a photo‐diagnosis was not possible

  • Waiting times for an appointment with a dermatologist

Notes This is a feasibility study conducted to assess possible adverse effects; waiting time monitored to assess whether participants initially assessed via photography but for whom diagnosis was not possible suffered from longer waiting times for an appointment than participants not assessed via photography
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote:
"The GP took photograph(s) of the skin condition and sent them with a referral letter to the dermatologist in a numbered, sealed envelope. The numbers previously were allocated randomly to study and control groups using a computer program"
Allocation concealment (selection bias) Low risk Quote:
"Group allocations were only revealed at hospital where photographs were removed from control group letters and appointments were made as usual"
Blinding of participants and personnel (performance bias) 
 Waiting time and number of visits to GPs before and after operation Low risk Blinding was not possible; however, waiting time is an objective outcome
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Not specified whether investigators were blinded, but given the objective nature of the assessed outcomes, whether the investigators were blinded was not likely to affect study results
Incomplete outcome data (attrition bias) 
 All outcomes High risk Only 18 of 71 (25.4%) intervention participants received a photo‐diagnosis and did not need to be seen by a dermatologist; 27 participants (38.0%) needed to be seen face‐to‐face for further management; for 26 intervention participants (36..6%), photo‐diagnosis was not possible
Selective reporting (reporting bias) Unclear risk Impossible to check against protocol (protocol not published)
Baseline characteristics similar? Low risk Quote:
"Study and control groups were similar in age (range: 5 months–94 years; mean 38.5 years, SD 23.2), gender [55 (40%) male; 81 (60%) female], numbers of patients not attending appointments and range of diagnoses (Table 1)"
Baseline outcomes similar? Low risk Not possible to provide baseline data for the outcome of interest
Free of contamination? Low risk Participants were the unit of randomisation, but despite this, It is unlikely that control group participants received the intervention
Other bias Low risk No obvious other risk of bias was identified