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. 2017 Jun 6;7(4):751–772. doi: 10.1007/s13142-017-0502-4

Table 1.

Characteristics related to external validity for trials in PRECIS-2 top tertile

First author, year, location Participants (n), age, females (%), non-white (%), HbA1c (mean) Clinical setting Intervention duration, intervention frequency, follow-up Intervention staff type, level of training
 Sperl-Hillen (IE) et al., 2011, USA I: n = 246, 61.6 yr., 49.4% f, 37.3% n-w, A1c—NR
C: n = 134, 63.3 yr., 46.3% f, 32.8% n-w, A1c—NR
2 large medical groups in NM and MN Duration: 3.8 mo.
Frequency: Three monthly 1-h sessions
Follow-up: 6.8 mo.
CDEs (RNs and RDs)
 Nielsen et al., 2006, Denmark I: n = 459, 65.5 yr., 47.6% f, NR n-w, A1c—10.2%
C: n = 415, 65.3 yr., 46.9% f, NR n-w, A1c—10.2%
187 solo practices and 124 group practices Duration: 6 yrs.
Frequency: consultations every 3 mo.
Follow-up: 6 yrs.
GPs
 Sperl-Hillen (GE) et al., 2011, USAa I: n = 243, 61.2 yr., 51.0% f, 33.5% n-w, A1c—NR
C: n = 134, 63.3 yr., 46.3% f, 32.8% n-w, A1c—NR
2 large medical groups in NM and MN Duration: 2.8 mo.
Frequency: Four 2-h sessions at 1-wk. intervals
Follow-up: 6.8 mo.
CDEs (RNs and RDs)
 Adachi et al., 2013, Japan I: n = 100, 60.4 yr., 55% f, NR n-w, A1c—NR
C: n = 93, 62.3 yr., 58% f, NR n-w, A1c—NR
Multiple clinics in Kanagawa prefecture, Japan Duration: 6 mo.
Frequency: 3–4 sessions
Follow-up: 6 mo.
Trained RDs
 Babamoto (CM) et al., 2009, USA I: n = 60, 50.0 yr., 52% f, NR n-w, A1c—8.5%
C: n = 54, 50.0 yr., 78% f, NR n-w, A1c—9.5%
3 inner city family health centers in Los Angeles, CA Duration: 6 mo.
Frequency: “usually seen on a monthly basis,” follow-up calls “as determined by the case manager” Follow-up: 6 mo.
Two linguistically competent and culturally sensitive RNs
 Davies et al., 2008, England and Scotland I: n = 437, 59.0 yr., 47% f, 6% n-w, A1c—8.3%
C: n = 387, 60.0 yr., 43% f, 6% n-w, A1c—7.9%
13 primary care sites Duration: 12 mo.
Frequency: One 6-h session delivered once at diagnosis
Follow-up: 12 mo.
Registered healthcare professionals
 Mash et al., 2014, South Africa I: n = 710, 55.8 yr., 71.5% f, NR n-w, A1c—8.9%
C: n = 860, 56.4 yr., 75.7% f, NR n-w, A1c—9.3%
34 community health centers in the working class areas of Cape Town Metropole, South Africa Duration: approximately 6 mo.
Frequency: Four 60-min sessions
Follow-up: 12 mo.
Health promoters recruited from district health services and trained over 6 days
 Shibayama et al., 2007, Japan I: n = 67, 61.0 yr., 34.8% f, NR n-w, A1c—7.3%
C: n = 67, 62.0 yr., 34.8% f, NR n-w, A1c—7.4%
OP clinic, Department of Diabetes and Metabolism, University of Tokyo Hospital Duration: 1 yr.
Frequency: monthly counseling
Follow-up: 1 yr.
CEN in diabetes nursing
 Irwig et al., 2012, USA I: n = 52, 54.8 yr., 50% f, 86.5% n-w, A1c—10.2%
C: n = 51, 57.2 yr., 56.9% f, 74.5% n-w, A1c—9.7%
Single academic multi-specialty clinic Duration: 9 mo.
Frequency: every 3 mo. (total of 4 visits)
Follow-up: 9 mo.
MDs (2 endocrinologists and 3 internists)
 Jansink et al., 2013, Netherlands I: n = 229, 64.1 yr., 44.1% f, NR n-w, A1c—7.8%
C: n = 292, 63.9 yr., 46.0% f, NR n-w, A1c—7.7%
58 general practices Duration: 14 mo.
Frequency: Four half-day training sessions spread over 6 mo; also received quarterly phone calls
Follow-up: 14 mo.
Primary care nurses
 De Greef et al. (GP), 2011, Belgium I: n = 22, 66.6 yr., 22.7% f, NR n-w, A1c—7.23% C: n = 24, 66.0 yr., 29.2% f, NR n-w, A1c—7.0% Three Belgian general practices Duration: 12 wks.
Frequency: Three individual 15-min face-to-face consultations
Follow-up: 12 wks.
GPs
 Christian et al., 2008, USA I: n = 155, 53.0 yr., 65% f, 100% n-w, A1c—8.08%
C: n = 155, 53.4 yr., 68% f, 100% n-w, A1c—8.29%
2 large urban community-based health centers in CO Duration: 12 mo.
Frequency: visits every 3 mo.
Follow-up: 12 mo.
MDs
 Trento et al., 2010, Italy I: n = 421, 69.0 yr., 52.0% f, NR n-w, A1c—7.75%
C: n = 394, 69.6 yr., 46.4% f, NR n-w, A1c—7.81%
13 hospital-based diabetes clinics Duration: 4 yrs.
Frequency: 7 1-h group care sessions every 3 months over 2 yr. and repeated; individual consultations at least yearly
Follow-up: 4 yrs.
MDs and an educationist (M.T.)
 Lee et al., 2011, Hong Kong I: n = 84, NR yr., 60.9% f, NR n-w, A1c—8.18%
C: n = 73, NR yr., 63.1% f, NR n-w, A1c—8.04%
General OP clinic, Hospital Authority New Territory East Cluster of Hong Kong Duration: 6 wks. Frequency: weekly 2.5-h DM self-management course Follow-up: 28 wks. Social worker accredited as a trainer for the self-management program
 DiLoreto et al., 2003, Italy I: n = 182, 62.0 yr., 51.6% f, NR n-w, A1c—7.6% C: n = 158, 61.6 yr., 53.8% f, NR n-w, A1c—7.7% OP diabetes clinic Duration: 2 yrs.
Frequency: initial 30-min counseling session, home phone call 1 mo. later; 15-min appointments in clinic every 3 mo.
Follow-up: 2 yrs.
MDs
 Glasgow (CASM) et al., 2012, USA I: n = 169, 58.7 yr., 44.6% f, 25.9% n-w, A1c—NR
C: n = 132, 58.7 yr., 51.5% f, 29.4% n-w, A1c—8.16%
Five primary care clinics within Kaiser Permanente Colorado Duration: 12 mo.
Frequency: initial website orientation; action plan at 6 wks; periodic motivational calls
Follow-up: 12 mo.
Research staff member
First author, year, location PA tracking method/feedback provided eHealth Control group Effectiveness (PA), effectiveness (HbA1c) PRECIS-2 score
 Sperl-Hillen (IE) et al., 2011, USA N/A N/A Usual care PA: yes HbA1c: yes 4.78
 Nielsen et al., 2006, Denmark N/A N/A Usual care PA: no HbA1c: yes 4.61
 Sperl-Hillen (GE) et al., 2011, USAa N/A N/A Usual care PA: no HbA1c: no 4.50
 Adachi et al., 2013, Japan N/A N/A General advice from RDs PA: NR HbA1c: yes 4.50
 Babamoto (CM) et al., 2009, USA N/A N/A Usual care PA: no HbA1c: no 4.44
 Davies et al., 2008, England and Scotland N/A N/A Enhanced standard care PA: no HbA1c: no 4.33
 Mash et al., 2014, South Africa N/A N/A Usual care PA: no HbA1c: no 4.33
 Shibayama et al., 2007, Japan Feedback provided at monthly sessions N/A Usual care PA: NR HbA1c: no 4.28
 Irwig et al., 2012, USA N/A N/A Completed questionnaires only PA: no HbA1c: no 4.28
 Jansink et al., 2013, Netherlands N/A N/A Usual care PA: no HbA1c: no 4.22
 De Greef et al. (GP), 2011, Belgium Pedometers used to track progress and to encourage discussions with the GP N/A Usual care PA: no HbA1c: no 4.17
 Christian et al., 2008, USA Results from computer-based assessment used to tailor intervention “Computer expert system” Usual care PA: yes HbA1c: no 4.17
 Trento et al., 2010, Italy N/A N/A Usual care PA: NR HbA1c: yes 4.17
 Lee et al., 2011, Hong Kong N/A N/A Usual care PA: no HbA1c: no 4.11
 DiLoreto et al., 2003, Italy Phone calls at 1 month to determine level of PA and reinforce instructions N/A Usual care PA: yes HbA1c: yes 4.11
 Glasgow (CASM) et al., 2012, USA Participants recorded progress on daily goals and received feedback using website “My Path toHealthy Life” (Mi Camino a La Vida Sana) website Enhanced usual care PA: yes HbA1c: no 4.08

C control group, CDE(s) certified diabetes educator(s), hr./hrs. hour/hours, I intervention group, MD(s) doctor(s), mo. month/months, N/A not applicable, NR not reported, OP outpatient, PA physical activity, PCP(s)/GP(s) primary care physician(s)/general practitioner(s), RD(s) registered dietitian(s), RN(s) registered nurse(s), wk./wks. week/weeks, yr./yrs. year/years

aA secondary intervention from an already noted study