Interventions to improve the management of diabetes mellitus in primary care, outpatient and community settings

Carry Mira Renders; Gerlof D Valk; Simon J Griffin; Edward Wagner; Jacques ThM van Eijk; Willem JJ Assendelft

doi:10.1002/14651858.CD001481

. 2000 Oct 23;2000(4):CD001481. doi: 10.1002/14651858.CD001481

Interventions to improve the management of diabetes mellitus in primary care, outpatient and community settings

Carry Mira Renders ^1,^✉, Gerlof D Valk ², Simon J Griffin ³, Edward Wagner ⁴, Jacques ThM van Eijk ⁵, Willem JJ Assendelft ⁶

Editor: Cochrane Effective Practice and Organisation of Care Group

PMCID: PMC7045779 PMID: 11279717

Abstract

Background

Diabetes is a common chronic disease that is increasingly managed in primary care. Different systems have been proposed to manage diabetes care.

Objectives

To assess the effects of different interventions, targeted at health professionals or the structure in which they deliver care, on the management of patients with diabetes in primary care, outpatient and community settings.

Search methods

We searched the Cochrane Effective Practice and Organisation of Care Group specialised register, the Cochrane Controlled Trials Register (Issue 4 1999), MEDLINE (1966‐1999), EMBASE (1980‐1999), Cinahl (1982‐1999), and reference lists of articles.

Selection criteria

Randomised trials (RCTs), controlled clinical trials (CCTs), controlled before and after studies (CBAs) and interrupted time series (ITS) analyses of professional, financial and organisational strategies aimed at improving care for people with Type 1 or Type 2 diabetes. The participants were health care professionals, including physicians, nurses and pharmacists. The outcomes included objectively measured health professional performance or patient outcomes, and self‐report measures with known validity and reliability.

Data collection and analysis

Two reviewers independently extracted data and assessed study quality.

Main results

Forty‐one studies were included involving more than 200 practices and 48,000 patients. Twenty‐seven studies were RCTs, 12 were CBAs, and two were ITS. The studies were heterogeneous in terms of interventions, participants, settings and outcomes. The methodological quality of the studies was often poor. In all studies the intervention strategy was multifaceted. In 12 studies the interventions were targeted at health professionals, in nine they were targeted at the organisation of care, and 20 studies targeted both. In 15 studies patient education was added to the professional and organisational interventions. A combination of professional interventions improved process outcomes. The effect on patient outcomes remained less clear as these were rarely assessed. Arrangements for follow‐up (organisational intervention) also showed a favourable effect on process outcomes. Multiple interventions in which patient education was added or in which the role of the nurse was enhanced also reported favourable effects on patients' health outcomes.

Authors' conclusions

Multifaceted professional interventions can enhance the performance of health professionals in managing patients with diabetes. Organisational interventions that improve regular prompted recall and review of patients (central computerised tracking systems or nurses who regularly contact the patient) can also improve diabetes management. The addition of patient‐oriented interventions can lead to improved patient health outcomes. Nurses can play an important role in patient‐oriented interventions, through patient education or facilitating adherence to treatment.

Plain language summary

Diabetes management in primary care, outpatient and community settings can be improved by interventions targeting health professionals, and organisational interventions that increase continuity of care

Diabetes is a major and growing health problem. This review examined the effects of interventions targeting health professionals or the way care is organised, with the aim of improving the management of people with diabetes in primary care, outpatient and community settings. The review found that multifaceted professional interventions (for example combinations of postgraduate education, reminders, audit and feedback, local consensus processes, and peer review) could enhance the performance of care providers. Organisational interventions that increased structured recall, such as central computerised tracking systems or nurses who regularly contacted patients, could also lead to improved care for patients with diabetes. The effectiveness of these interventions on patient outcomes (glycaemic control, cardiovascular risk factors, wellbeing) is less clear.

Background

Description of the condition

Diabetes mellitus is a major and still growing health problem. It is expected that the number of people with diabetes will double by 2010 (Amos 1997). In particular, the number of patients with Type 2 diabetes is continuing to rise due to the increasing number of elderly people, the better recognition of prevalent undiagnosed diabetes and the better care for and survival of people with clinically diagnosed diabetes (Burke 1999; Meneilly 1995). Furthermore, the adoption of a more affluent and westernised lifestyle (characterised by decreased physical activity, greater fat consumption and subsequent obesity) by some non‐Western populations is also contributing to an increase in the diabetic population (Roman 1997). Though the rise in prevalence of patients with diabetes mellitus is mainly due to Type 2 diabetes, alarming increases in Type 1 diabetes have also been observed (Gardner 1997; Libman 1998; Onkamo 1999).

Description of the intervention

Since 1970 the responsibility for the routine review of patients with diabetes has shifted away from hospitals to primary care (Wood 1990; Griffin 1997). Nowadays health professionals working in primary care, outpatient and community settings often play a key role in the care of patients with diabetes (Laine 1996). In particular, centralised, computer‐based systems for prompted recall and regular review of patients play a very important part in delivering a good standard of diabetes care (Wood 1990; Griffin 1998a).

Nevertheless, empirical data suggest that care for diabetic patients in primary care, outpatient and community settings could be improved. Studies in the USA have shown that a large proportion of elderly patients with diabetes mellitus are not receiving care in accordance with the published guidelines of the American Diabetes Association (ADA) (Weiner 1995; Beckles 1998). In addition, a Dutch study observed that general practitioners' management of patients with Type 2 diabetes only partly adhered to the published guidelines of the Dutch College of General Practitioners (Grol 1990; Konings 1995). Physicians' management of patients with Type 1 diabetes has also been found to be sub‐optimal (Tuttleman 1993).

How the intervention might work

Achieving good glycaemic control is important. The Diabetes Control and Complications trial proved that good glycaemic control in patients with Type 1 diabetes reduced the occurrence of retinopathy, nephropathy and neuropathy (DCCT 1993). The United Kingdom Prospective Diabetes Study (UKPDS 1998) found the same to be true for patients with Type 2 diabetes. Furthermore, patients with Type 1 and Type 2 diabetes with good glycaemic control reported a better functional status and greater well‐being (Ahoroni 1994; van der Does 1996; Reichard 1996). Many diabetic patients, however, have poor glycaemic control (Mazze 1995; Nathan 1995).

Attention to other cardiovascular risk factors is also an important aspect of diabetes management. Type 2 diabetes in particular is associated with a greater risk of heart disease and stroke, because of the interaction between raised concentrations of glucose and other cardiovascular risk factors (Turner 1998; Kuusisto 1994). Patients with Type 2 diabetes have a two‐ to three‐fold increased risk of macrovascular disease (Garcia 1974; Stamler 1993). These cardiovascular risk factors often go unrecognised and undertreated in patients with Type 2 diabetes (Stolar 1995).

Why it is important to do this review

In the last few years a wide range of interventions targeting professional behaviour or the structure of care has been implemented to achieve better metabolic control or to improve care delivered to patients with diabetes. This review aims to identify and describe interventions to improve the management of patients with diabetes mellitus in primary care, outpatient and community settings.

Objectives

The objectives of this review are to determine the effectiveness of different interventions, targeted at health care professionals or the structure in which health care professionals deliver their care, to improve the care for patients with diabetes in primary care, outpatient and community settings.

Secondary questions are:   Which intervention strategy or parts of intervention strategies are the most effective? What do the most effective strategies have in common?

Methods

Criteria for considering studies for this review

Types of studies

1) Randomised or quasi‐randomised controlled trials (RCTs)   2) Controlled clinical trials (CCTs)   3) Controlled before and after studies (CBAs)   4) Interrupted time series (ITSs)

Types of participants

Health care professionals (including physicians, nurses, pharmacists), taking care of non‐hospitalised patients with Type 1 or Type 2 diabetes mellitus in a primary care, outpatient (eg ambulatory care provided by specialists/hospitals) or community setting (managed care organisations, general medical clinics)

Types of interventions

Intervention strategies to improve the care for patients with diabetes, including organisational, professional and financial interventions. These were classified according to the Cochrane Effective Practice and Organisation of Care Group (EPOC) taxonomy of interventions (see EPOC 2008).

Studies that only evaluated patient oriented interventions (eg patient education, mail order pharmacies, consumer participation in health care organisation) were excluded. However, we abstracted information about patient oriented interventions included alongside professional and organisational interventions.

Types of outcome measures

Objectively measured health professional performance or patient outcomes in a clinical setting and self report measures with known validity and reliability.

1) Health professional performance, including (process outcomes):

Measurement of blood pressure, blood glucose, HbA1c, weight, cholesterol, HDL‐cholesterol, triglycerides, serum creatinine; urinalysis; making a follow‐up; referral; examination of the feet; visual acuity and retinal fundi.

2) Patient outcomes, including:

Glycaemic control: HbA1c, blood glucose
Micro‐ or macro‐vascular complications: nephropathy, retinopathy, neuropathy, cardiovascular diseases, amputations
Cardiovascular risk factors: weight, cholesterol, triglycerides, albumin, serum creatinine, blood pressure, BMI
Hospital admissions
Mortality

3) Self report measures with known validity and reliability, including:

Well‐being/perceived health/quality of life/functional status/patient satisfaction: scores on validated generic and disease‐specific measures
Patient satisfaction
Provider satisfaction

Search methods for identification of studies

Electronic searches

Relevant studies meeting the inclusion criteria for the review were identified by:

a) Searching MEDLINE (from 1966 to 1999), EMBASE (from 1980 to 1999), Cinahl (from 1982 to 1999), the Cochrane Diabetes Group specialised register, the Cochrane Effective Practice and Organisation of Care Group specialised register (Issue 4 1999) and The Cochrane Library (Issue 4 1999).

b) Screening references given in relevant reviews and studies.

The methodological terms from the existing EPOC search strategy were combined with:   1. family practice/   2. family pract$.tw.   3. general practice.sh.   4. general pract$.tw.   5. primary health care/   6. primary care/   7. community health services/   8. community care   9. shared care   10. patient care team   11. integrated care   12. ambulatory care   13. family medicine/   14. family physician/   15. family phys$.tw.   16. exp diabetes mellitus/   17. diabet$.tw.   18. diabetes insipidus/   19. 17 not 18   20. 16 or 19   21. or/1‐15   22. 20 and 21

The search terms were refined following initial experience.

Studies published in languages other than English were included.

Data collection and analysis

Full text copies of all potentially relevant studies, determined by reviewing the abstracts, were obtained. For each part of the review, studies were assessed for inclusion independently by two reviewers (CMR/GDV). All studies that appeared initially to meet our inclusion criteria, but on closer examination failed to, are detailed in the Characteristics of excluded studies. When there was a difference of opinion between reviewers concerning the inclusion of a trial the opinion of the EPOC contact editor was sought.

The data extraction was performed independently by two reviewers (CMR, GDV) using an adapted version of the EPOC Data Collection Checklist (see METHODS USED IN REVIEWS under GROUP DETAILS). Any discrepancies between reviewers were resolved by discussion or referred to the EPOC contact editor. The quality of all eligible trials was assessed using the criteria described by the EPOC group (see ADDITIONAL INFORMATION, ASSESSMENT OF METHODOLOGICAL QUALITY under GROUP DETAILS). (The EPOC data collection checklist, which contains information on the quality criteria used to assess studies, is available from the EPOC web site: EPOC a) Missing information about study design and intervention characteristics was sought from the main authors.

Initial disagreement about the assessment of the most important items (study design, classification of the intervention strategy and the quality criteria: blinding assessment, baseline measurement, follow‐up of patients and 'unit of analysis' error), was calculated per criteria item and expressed as percentage agreement .

Data analysis:

Given the likely heterogeneity of interventions, settings and patient populations, we decided a priori not to use meta‐analysis to pool the results of studies. Instead we present the results of studies in tabular form and make a qualitative assessment of the effects of studies, based upon the study quality, the size and direction of effect observed and the statistical significance of the studies.

We present the following data (where available): pre‐intervention study and control data in natural units and statistical significance across groups; post‐intervention study and control data in natural units and statistical significance across groups; absolute and relative percentage improvement. If a unit of analysis error was present, we presented the point estimates of effects without p‐values or 95% confidence intervals.

We assessed whether the type of intervention (eg professional or organisational), source of intervention (eg whether the intervention was carried out or supported by a professional organisation) and type of diabetes influence the effectiveness of the interventions (Type 1 diabetes requires more intensive follow‐up and more intensive management).

The included studies are presented in three groups as we classified the intervention strategies in professional, organisational or a combination of both interventions. In the results paragraph a detailed description is given of the individual studies followed by a more general conclusion of the effectiveness of that group of interventions.

In Table 1, Table 2, Table 3, detailed information is given about the process and patient outcomes assessed in the studies. In addition, a summarised table of results is presented.

1. Table of summarised results for professional interventions vs usual care.

Study	Comparison	Effect on practice	Effect on patient	Notes
Benjamin 1999	Educational materials + educational meetings + local consensus processes + audit and feedback vs no intervention on diabetes	chol (+)#   microv (+)#	glyc (+)#	No post intervention screening rates were reported for the control group. The authors stated that there was little change in screening rates for the control group over the entire study period compared with improvements seen in the intervention group     +=positive effect   0=no effect   ‐=negative effect,   +/‐=unclear   #= a possible unit of analysis error   glyc=glycaemic control   bp=blood pressure,   BMI=BMI   chol=cholesterol   alb=albumin   creat=creatinin   microv/macrov=micro‐ macrovascular complications   well=wellbeing   hlth surv=health survey   compl=compliance care provider   att pat=attendance patients   hosp=hospitalisations   s‐rep health=self reported health   qual life=quality of life
Feder 1995	Educational materials + local consensus processes + educational outreach visits + reminders vs no intervention on diabetes	glyc (+)   bp (+)   weight (+)   microv (+)	N/A
Kinmonth 1998	Educational materials +   educational meetings + educational materials for patients vs no intervention to support patient centred care, but support sessions focusing on use of guidelines and materials	N/A	glyc (0)   bp (0)   chol (0)   BMI (‐)   alb (0)   well (+)
Litzelman 1993	Educational materials + reminders + patient education + behavioural contacts with patients + reminders for patients vs no intervention	microv (+)#	microv (+)#
Lobach 1997	Local consensus processes + audit and feedback + reminders vs no intervention	glyc (0)#   chol (+)#   ur prot (+)#   microv (‐)#   compl (+)#	N/A
Mazze 1994	Distribution of educational materials + educational meetings + local consensus processes + reminders vs no intervention	visits (+/‐)   microv (+/‐)   educ (+/‐)   hlth surv (+/‐)	glyc (+/‐)	No statistical analyses were undertaken, but there was a positive trend
Mazzuca 1990	Group A (control group) postgraduate seminar vs   Group B: A+reminders vs   Group C: B+clinical materials vs   Group D: C+diabetes patient education service	glyc (+)	N/A
Palmer 1990	Educational materials + local consensus procedures + audit and feedback vs no intervention	compl (0)	N/A	Possible ceiling effect: baseline variant scores are low
Pieber 1995	Educational materials + educational meetings + patient education vs no intervention	N/A	glyc (+)#   bp (0) #   chol (0)#   BMI (+)#   microv (+)#	The difference in microvascular complications was only tested within groups, not between groups
Pill 1998	Educational meetings + educational outreach visits vs no intervention	att pat (0)#	glyc (0)#   bp (0)#   BMI (0)#   mic/macrov (0)#
Ward 1996	Educational materials + educational outreach visits + audit and feedback by interview vs educational materials + postal feedback	glyc (+)   bp (0)   chol (+)   weight (+)   alb (+)   microv (+)   compl (+)	N/A	Only the difference in compliance rate was tested between groups, the differences in the other outcomes were tested within groups.
Carlson 1991	Educational meetings + local consensus processes to identify problems and to create plans to improve diabetes care	glyc (+)#   microv (+)#	glyc (0)#

Date	Event	Description
6 November 2008	Amended	Converted to new review format.
29 June 2000	New citation required and conclusions have changed	Substantive amendment

Methods	RCT (randomisation was based on a 1:1 allocation ratio and block size of three, randomised by patient)   Randomisation concealment: DONE   Follow up:   ‐ providers: N/A   ‐ patients: NOT DONE   Blinded assessment: DONE for laboratory outcomes and self‐reported health status score   NOT CLEAR for blood pressure and weight   Baseline: DONE   Reliable outcomes: DONE for laboratory outcomes and self‐reported health status score   NOT CLEAR for blood pressure and weight   Protection against contamination: D
Participants	Two of the largest clinics within the Jacksonville Health Care Group, which provides primary care services for the Prudential HealthCare HMO plan of Jacksonville, Florida (US).   A nurse case manager was the primary care provider under the direction of a board‐certified family medicine physician and an endocrinologist who were still responsible for all diabetes management decisions for patients in the intervention group.   Patients visiting the clinic (Type 1 and Type 2 diabetes)   providers ‐ ? (nurse)   patients ‐ 138   practices ‐ 2
Interventions	Intervention group: Professional intervention (distribution of educational materials (detailed management algorithms) + organisational intervention (revision of professional roles (nurse case management) + arrangements for follow‐up) + patient education Control group: usual care (patients in the control group were encouraged to discuss enrolment in the diabetes education class with their physicians) Length of intervention:   1 year in which patients received follow‐up telephone calls every two weeks. Patients who were taking insulin received weekly calls
Outcomes	PROCESS:   Renal assessment:   ‐Dipstick test   ‐Quantitative protein/microalbumin PATIENT:   HbA1c   Mean fasting blood glucose   Insulin dose   Systolic blood pressure Diastolic blood pressure   Weight   Serum cholesterol   Serum triglycerides   Serum HDL‐cholesterol   Serum LDL‐cholesterol   Self‐reported health status score
Notes	Algorithms locally developed by a multidisciplinary team   ‐directed at adjustments in medication, meal planning and reinforcement of exercise   ‐target: improvement of glycaemic control and monitoring of renal complications
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate

Methods	CBA   Characteristics of studies using second site as control: NOT DONE   Follow up:   ‐ providers: NOT CLEAR   ‐ patients: NOT DONE   Blinded assessment: DONE for HbA1c, NOT CLEAR for process measures   Baseline: DONE for HbA1c, NOT DONE for eye exam, urine test for albumin/protein   Reliable outcomes: DONE for HbA1c, NOT CLEAR for process outcomes   Protection against contamination: DONE unit of analysis error
Participants	Outpatient clinics of Baystate Medical Center, Springfield (US). This Medical Center has a "firm" system that is an academic group practice that includes attending physicians, residents, nurses, a nutritionist and patients. The firm system creates two group practices that are essentially parallel groups of providers and patients.   Patients are predominantly minority patients of Hispanic and African‐American descent. (Type 2 diabetes)   providers ‐ ?   (physicians,   residents, nurses,   nutritionist)   patients ‐ 144   practices ‐ 2 firms
Interventions	Intervention group: Professional intervention (distribution of educational materials (guidelines) + educational meetings + local consensus processes + audit and feedback) Control group: usual care Length of intervention:   15 months
Outcomes	PROCESS:   Compliance with standards of care:   ‐Annual urine test for albumin/protein   ‐Annual cholesterol determination   ‐Annual diabetes education   ‐Annual dilated retinal exam   ‐Annual influenza vaccinations   ‐Annual nutrition education PATIENT:   HbA1c
Notes	Guidelines were locally developed by residents and faculty   ‐directed at adjustments in treatment and monitoring   ‐target: improvement of glycaemic control and compliance with recommended standards
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	D ‐ Not used

Methods	RCT (incomplete block design randomised by practices; 2 groups of practices (where nurses were involved or nurses were not involved) were randomised in two groups)   Randomisation concealment: NOT CLEAR   Follow up:   ‐ providers: NOT CLEAR   ‐ patients: NOT DONE   Blinded assessment: DONE for HbA1c   NOT CLEAR for measurements of professional practice Baseline: NOT CLEAR   Reliable outcomes: DONE for HbA1c   NOT CLEAR for measurements of professional practice   Protection against contamination: DONE unit of analysis error
Participants	34 primary health care centres (PHCC) in the Stockholm area in Sweden   Patients who had visited the PHCC during the 12 months prior to the evaluation (not clear which type of diabetes)   providers‐ ? (mixed: physicians, nurses, nurse assistants, managers, administrators,   laboratory technicians)   patients ‐ 4492   (measurements on professional practice)   patients ‐ 566   (measurements on HbA1c)   practices ‐ 3
Interventions	Intervention group:   Professional intervention (educational meetings + local consensus processes to identify problems and to create plans to improve diabetes care + educational outreach visits) Control group: usual care Length of intervention:   18 months   Follow up period: lasted 12 months
Outcomes	PROCESS:   ‐Patients height noted in case notes during previous year   ‐HbA1c value measured during previous year:   ‐Eye examination performed during previous year PATIENT:   HbA1c
Notes	A national Diabetes Control Program was initiated in 1979   ‐directed at organization of care   ‐ target glycaemic control and care routines as measured by audit of case records
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Methods	RCT (2x2 balanced incomplete block design, randomised by practice)   Randomisation concealment: NOT CLEAR   Follow up:   ‐ providers: NOT CLEAR   ‐ patients: N/A   Blinded assessment: NOT CLEAR   Baseline: DONE   Reliable outcomes: DONE except for examination of feet   Protection against contamination: DONE no unit of analysis error
Participants	24 of 49 non‐training practices in Hackney , East London (UK).   39 providers and per provider a sample size of 10 patients was selected by a method using random numbers (not clear which type of diabetes).   providers ‐ 39   physicians supported by nurses   patients ‐ 390   practices ‐ 24
Interventions	Intervention group: Professional intervention (distribution of educational materials + local consensus processes + educational outreach visits + reminders) Control group: practices who received guidelines on asthma and provided usual diabetes care Length of intervention:   1 year
Outcomes	PROCESS:   Recording of:   Funduscopy   Blood glucose   Weight   Blood pressure   Smoking habit   Feet   HbA1 PATIENT:   NONE
Notes	Guidelines were developed by local general practitioners working through informal consensus with local hospital specialists and relevant professionals. They were based on the St Vincents' declaration   ‐directed at monitoring   ‐targets: glycaemic control, visual impairments, blood pressure, weight, feet examination, smoking habit
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Methods	RCT (design not clear randomised by patient)   Randomisation concealment: NOT CLEAR   Follow up:   ‐ providers: N/A   ‐ patients: NOT CLEAR   Blinded assessment: DONE   Baseline: NOT CLEAR   Reliable outcomes: DONE   Protection against contamination: DONE
Participants	Diabetic patients who were enrolled in a large network‐based Health Maintenance Organisation (HMO) in California (US) and the medical groups that treated the identified diabetic patients (Type 1 and Type 2 diabetes)   providers ‐ ?   patients ‐ 19,523   practices ‐ 1 Health   Maintenance   Organisation, the   number of medical   group is not clear
Interventions	Intervention group:   Organisational intervention (arrangements for follow‐up) Control group: as in the intervention group, they received guidelines, a list of their diabetes patients with their diabetic retinopathy screening exam status and patients without a record of diabetic retinopathy exam received educational materials.   In contrast with the patients in the intervention group who received multiple reminders, the patients received a single reminder
Outcomes	PROCESS:   Rates of retinal examination PATIENT:   NONE
Notes	National guidelines (ADA guidelines)   ‐directed at monitoring   ‐target: retinopathy screening
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Methods	RCT (randomised by patient)   Randomisation concealment: NOT CLEAR   Follow up:   ‐ providers: N/A   ‐ patients: NOT CLEAR   Blinded assessment: NOT CLEAR   Baseline: NOT CLEAR   Reliable outcomes: DONE   Protection against contamination: NOT CLEAR
Participants	A medical follow‐up clinic at the Robert B. Green Hospital in San Antonio, TX (US). It serves as a primary care training facility. 1148 of 1722 patients enrolled in the clinic were included in the study. 90% of the patients were Mexican American and more than 95% were indigent. Patients were being followed for hypertension, diabetes or both. The number of included patients with only diabetes is not clear, but 315 patient with diabetes were included in the analyses and completed the 29 month trial (not clear which type of diabetes)   providers ‐ ?   (pharmacist (interv group) + physicians (control group))   patients ‐ 315   practices ‐ 1 clinic
Interventions	Intervention group:   Organisational intervention (revision of professional rules   (A clinical pharmacist was responsible for follow‐up care of patient with diabetes)) Control group: usual care Length of intervention:   29 months
Outcomes	PROCESS: NONE PATIENT:   Fasting blood glucose
Notes	Not specified in the paper
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	D ‐ Not used

Methods	RCT (pragmatic parallel group design, randomisation by practices)   Randomisation concealment: DONE   Follow up:   ‐ providers: DONE   ‐ patients: NOT DONE   Blinded assessment: DONE   Baseline: DONE for BMI, blood pressure,   NOT CLEAR HbA1c, total cholesterol, triglyceride, urinary albumin/Creatinine   Reliable outcomes: DONE for laboratory outcomes   NOT CLEAR for blood pressure, BMI   Protection against contamination: DONE no unit of analysis error, because patients' results were corrected for clustering at practice level
Participants	41 practices of 245 eligible practices in a health region in southern England. 245/467 of all practice teams were eligible. 360 of 522 patients were eligible for inclusion. 250 patients completed the study (Type 2 diabetes).   providers ‐ 43 doctors   supported by 64   nurses   patients ‐ 360   practices ‐ 41
Interventions	Intervention group:   Professional intervention (distribution of educational materials + educational meetings (training in patient centred care)) + patient education (booklet for patients) Control group:   received no training in patient centred care but were also offered special support sessions focusing on use of guidelines and materials Length of intervention:   1 year
Outcomes	PROCESS:   NONE PATIENT:   HbA1c   Total cholesterol   Triglyceride   BMI   Systolic blood pressure   Diastolic blood pressure   Urinary albumin/Creatinine Quality of life Depressed Wellbeing Wellbeing overall   Subscales   Depression   Anxiety   Energy   Positive wellbeing
Notes	National guidelines   ‐directed at monitoring and treatment   ‐targets: clinical, social and psychological outcomes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate

Methods	RCT (randomised by practice team)   Randomisation concealment: NOT CLEAR   Follow up:   ‐ providers: NOT CLEAR   ‐ patients: NOT DONE   Blinded assessment: DONE Baseline: NOT CLEAR   Reliable outcomes: NOT CLEAR   Protection against contamination: NOT CLEAR unit of analysis error
Participants	Academic general medicine practice of the Regenstrief Health Center in Indianapolis, Indiana (US).   The practice is subdivided in 4 practice teams.   Only patients that were seen at least two times in the preceding year by the same provider were included. Patients of investigators involved in the protocol were also excluded. Of 728 eligible patients, 395 patients entered the study and 352 completed the study (Type 2 diabetes).   providers ‐ ?   (physicians supported   by nurses (education))   patients ‐ 395   practices ‐ 1
Interventions	Intervention group: Professional intervention (distribution of educational materials + reminders) + patient education sessions + behavioural contracts + reminders for patients Control group: usual care Length of intervention:   1 year
Outcomes	PROCESS:   Percentage of patients with documentation:   Ulcers   Pulse examination done   Dry or cracked skin   Calluses or corns   Fungal infection (foot or nail)   Ingrown nails   Improperly trimmed nails   Foot or leg cellulitis   Foot deformities   Sensory examination done PATIENT:   Serious foot lesions   All foot lesions   Dry or cracked skin   Ingrown nails   Fungal nail infection   Fungal skin infection   Interdigit maceration
Notes	Local guidelines   ‐directed at   foot‐care practice for assessment, diagnostic work‐up, treatment and referral recommendations   ‐targets: physicians' documentation of the presence of lower extremity clinical abnormalities and the prevalence of lower extremity clinical abnormalities
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Methods	RCT (randomised by provider)   Randomisation concealment: NOT CLEAR   Follow up:   ‐ providers: NOT DONE   ‐ patients: NOT CLEAR   Blinded assessment: DONE   Baseline: DONE   Reliable outcomes: NOT DONE   Protection against contamination: DONE unit of analysis error
Participants	Primary care clinic at Duke University Medical Center (North Carolina, US)   20 family physicians, 1 general internist, 2 nurse practitioners, 2 physician's assistants, 33 family medicine residents were randomised. 30 were included because they met predefined criteria for minimum exposure to diabetic patient care.   359 charts were included with 884 encounters in which diabetes was addressed (not clear which type of diabetes)   providers ‐ 30 primary care clinicians   patients ‐ 359   encounters ‐ 884   practices ‐ 1 primary care clinic
Interventions	Intervention group: Professional intervention (local consensus processes + audit and feedback + reminders) Control group:   usual care Length of intervention:   6 months
Outcomes	PROCESS:   Compliance rate overall Compliance rate with regard to specific guidelines on:   Foot examination   Complete physical examination   Chronic glycemia monitoring   Urine protein determination   Cholesterol level   Ophthalmologic examination   Influenza vaccination   Pneumococcal vaccination PATIENT:   NONE
Notes	National guidelines (ADA‐guidelines), adapted through a consensus building process   ‐directed at monitoring and treatment   ‐targets: compliance with guidelines
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Study	Comparison	Effect on practice	Effect on patient	Notes
Benjamin 1999	Educational materials + educational meetings + local consensus processes + audit and feedback vs no intervention on diabetes	Rates of compliance with standards of care:     Annual urine test for albumin/protein (%):   Baseline: 45 vs 67   Post intervention: 91 vs NA   Absolute difference: NA   Relative improvement: NA     Annual cholesterol determination (%):   Baseline: 58 vs 52   Post intervention: 77 vs NA   Absolute difference: NA   Relative improvement: NA     Annual diabetes education (%):   Baseline: 23 vs 21   Post intervention: 84 vs NA   Absolute difference: NA   Relative improvement: NA     Annual dilated retinal exam (%):   Baseline: 32 vs 59   Post intervention: 63 vs NA   Absolute difference: NA   Relative improvement: NA     Annual influenza vaccinations (%):   Baseline: 30 vs 24   Post intervention: 73 vs NA   Absolute difference: NA   Relative improvement: NA     Annual nutritional education (%):   Baseline: 37 vs 43   Post intervention: 67 vs NA   Absolute difference: NA   Relative improvement: NA   Rates of compliance with standards of care:     Annual urine test for albumin/protein (%):   Baseline: 45 vs 67   Post intervention: 91 vs NA   Absolute difference: NA   Relative improvement: NA     Annual cholesterol determination (%):   Baseline: 58 vs 52   Post intervention: 77 vs NA   Absolute difference: NA   Relative improvement: NA     Annual diabetes education (%):   Baseline: 23 vs 21   Post intervention: 84 vs NA   Absolute difference: NA   Relative improvement: NA     Annual dilated retinal exam (%):   Baseline: 32 vs 59   Post intervention: 63 vs NA   Absolute difference: NA   Relative improvement: NA     Annual influenza vaccinations (%):   Baseline: 30 vs 24   Post intervention: 73 vs NA   Absolute difference: NA   Relative improvement: NA     Annual nutritional education (%):   Baseline: 37 vs 43   Post intervention: 67 vs NA   Absolute difference: NA   Relative improvement: NA	HbA1c (ref. 3.5‐6.0%):   Baseline: 9.30 ±0.32 vs 9.21±0.32   Post intervention (9 months): 8.42 ± 0.30 vs 9.41± 0.29 (p=0.001)   Post intervention (15 months): 8.68 ±0.28 vs 9.15± 0.32 (p=0.009)   Absolute difference (9 months): 1.01   Absolute difference (15 months): 0.47   Relative improvement: 11%   Relative improvement: 5%   DE‐DC= 1.08 (9 months)   DE‐DC= 0.56 (15 months)   HbA1c (ref. 3.5‐6.0%):   Baseline: 9.30 ±0.32 vs 9.21±0.32   Post intervention (9 months): 8.42 ± 0.30 vs 9.41± 0.29 (p=0.001)   Post intervention (15 months): 8.68 ±0.28 vs 9.15± 0.32 (p=0.009)   Absolute difference (9 months): 1.01   Absolute difference (15 months): 0.47   Relative improvement: 11%   Relative improvement: 5%   DE‐DC= 1.08 (9 months)   DE‐DC= 0.56 (15 months)	No post intervention screening rates were reported for the control group. The authors stated that there was little change in screening rates for the control group over the entire study period compared with improvements seen in the intervention group     Significant difference between both groups at baseline:   for annual urine test for albumin/protein (p<0.05) and for eye exams (p<0.01)     **Rates of compliance with standard outcomes significantly improved for all process outcomes in the intervention group (p<0.001). For annual cholesterol determination p<0.02
Feder 1995	Educational materials + local consensus processes + educational outreach visits + reminders vs no intervention on diabetes	Average % of patients with variable recorded at baseline and after one year (average is weighted by number of patients sampled in practice)     Funduscopy (%):   Baseline: 20.5 vs 19.4   Post intervention: 38.1 vs 20   Absolute difference: 18.1%   Difference in proportions (95% CI)   17.6 (6.9 to 33.9)   Relative improvement: 88%     Blood glucose (%):   Baseline: 56.8 vs 57.8   Post intervention: 75.2 vs 57.8   Absolute difference: 17.4%   Difference in proportions (95% CI)   20.2 (6.4 to 33.9)   Relative improvement: 34.9%     Weight (%):   Baseline: 40.4 vs 37.5   Post intervention: 68.1vs 40   Absolute difference: 28.1%   Difference in proportions (95% CI)   26.5 (7.7 to 45.4)   Relative improvement: 66.3%     Blood pressure (%):   Baseline: 69.0 vs 66.1   Post intervention: 79.5 vs 58.3   Absolute difference: 21.2%   Difference in proportions (95% CI)   18.1 (2.8 to 33.4)   Relative improvement: 31%     Smoking habit (%):   Baseline: 34.8 vs 23.2   Post intervention: 62.4 vs 31.7   Absolute difference: 30.7%   Difference in proportions (95% CI)   25.5 (8.7 to 42.3)   Relative improvement: 80.4%     Feet examination (%):   Baseline: 31.4 vs 28.3   Post intervention: 51.8 vs 27.2   Absolute difference: 24.6%   Difference in proportions (95% CI)   24.7 (7.1 to 42.3)   Relative improvement: 90.8%     HbA1 recorded (%):   Baseline: 24.8 vs 20.6   Post intervention: 48.1 vs 30   Absolute difference: 18.1%   Difference in proportions (95% CI)   13.8 (1.2 to 26.3)   Relative improvement: 46%	Not done	*Intervention and control practices had similar distributions of variables at baseline, except for the recording of smoking habit, which was significantly greater in the diabetes practices. Differences at baseline were taken into account in the regression models testing the effect of the guidelines (reported difference in proportions).
Kinmonth 1998	Educational materials +   educational meetings + educational materials for patients vs no intervention to support patient centred care, but support sessions focusing on use of guidelines and materials	Not done	Means with 95% confidence intervals     HbA1c (ref. 4.68‐6.8%):   Post intervention: 7.07 (4.17‐12.83) vs 7.17 (4.16‐14.05)   (N=131 vs 100)   Absolute difference: 0.10   Relative improvement: 1.4%   Adjusted p‐value=0.31*     Total cholesterol (mmol/l):   Post intervention: 6.04 (3.70‐9.80) vs 5.99 (3.30‐9.10)   (N=138 vs 102)   Absolute difference: ‐0.05   Relative improvement: ‐0.8%   Adjusted p‐value=0.92     Triglycerides (mmol/l):   Post intervention: 2.62 (0.60‐13.5) vs 2.23 (0.60‐11.6)   (N=130 vs N=101)   Absolute difference: ‐0.39   Relative improvement:   ‐17.5%   Adjusted p‐value=0.02     BMI (kg/m²):   Baseline: 30.6 (18.7‐49.6) vs 29.7 (18.9‐52.2) (N=142 vs 108)   Post intervention: 31.3 (19.8‐51.9) vs 29.5(19.1‐48.5)   (N=138 vs 102)   Absolute difference: ‐1.8   Relative improvement:   ‐6%   DE‐DC= ‐0.9   Adjusted p‐value=0.03     Systolic blood pressure (mmHg):   Baseline: 144.1 (80.0‐190.0) vs 141.5 (100.0‐200.0)   (N=142 vs 108)   Post intervention: 144.3 (99.0‐193.5) 142.8 (87.0‐204.0)   (N=138 vs 107)   Absolute difference: ‐1.5   Relative improvement:   ‐1%   DE‐DC= 1.1   Adjusted p‐value p=0.18     Diastolic blood pressure (mmHg):   Baseline: 85.5 (60.0‐118.0) vs 83.7 (50.0‐110.0)   (N=142 vs 108)   Post intervention: 89.0 (59.5‐133.5) vs 87.2 (60.5‐131.0)   (N=138 vs 107)   Absolute difference: ‐1.8   Relative improvement:   ‐2%   DE‐DC= 0.0   Adjusted p‐value=0.10     Generic   Wellbeing questionnaire overall:   Post intervention: 48.0 (15.0‐66.0) vs 45.9 (3.0‐66.0)   Absolute difference: 2.1   Relative improvement:   5%   Adjusted p‐value=0.03	Analysis was by intention to treat. Multiple or logistic regression was used as appropriate. Adjustments were made for district general hospital, practice list size, organisation of diabetes care, clustering for patients by practice     *The two groups did not differ in micro‐albuminuria, smoking status, diabetes specific quality of life
Litzelman 1993	Educational materials + reminders + patient education + behavioural contacts with patients + reminders for patients vs no intervention	Percentage of patients with documentation:     Ulcers (%):   Post intervention: 23.8 vs 11.1   Absolute difference: 12.7%   Relative improvement: 114%     Pulse examination done:   Post intervention: 9.2 vs 3.0   Absolute difference: 6.2%   Relative improvement: 207%     Dry or cracked skin   Post intervention: 8.7 vs 2.0   Absolute difference: 6.7%   Relative improvement: 335%     Calluses or corns:   Post intervention: 6.5 vs 1.0   Absolute difference: 5.5%   Relative improvement: 550%     Fungal infection (foot or nail):   Post intervention: 3.2 vs 0.5   Absolute difference: 2.7%   Relative improvement: 540%     Ingrown nails:   Post intervention: 2.7 vs 0.5   Absolute difference: 2.2%   Relative improvement: 440%     Improperly trimmed nails:   Post intervention: 2.4 vs 0.5   Absolute difference: 1.9%   Relative improvement: 380%     Foot or leg cellulitis   Post intervention: 2.7 vs 1.5   Absolute difference: 1.2%   Relative improvement: 80%     Foot deformities:   Post intervention: 1.6 vs 1.0   Absolute difference: 0.6%   Relative improvement: 60%     Sensory examination done:   Post intervention: 4.9 vs 2.5   Absolute difference: 2.4%   Relative improvement: 96%	Serious foot lesions:   Baseline prevalence intervention group: 2.9%   OR: 0.41 [0.16‐1.00]**     All foot lesions:   Baseline prevalence intervention group: 10.5%   OR: 0.65 [0.36‐1.17]     Dry or cracked skin:   Baseline prevalence intervention group: 83.5%   OR: 0.62 [0.39‐0.98]     Ingrown nails:   Baseline prevalence intervention group: 18.5%   OR: 0.59 [0.39‐0.92]     Fungal nail infection:   Baseline prevalence intervention group: 67.0%   OR: 0.70 [0.46‐1.07]     Fungal skin infection:   Baseline prevalence intervention group: 12.3%   OR: 0.58 [0.30‐1.12]     Interdigit maceration:   Baseline prevalence intervention group: 18.8%   OR: 0.63 [0.34‐1.15]	No p‐value given because of potential unit of analysis error     adjusted for baseline measurements     **Authors reported significant differences between both groups on   1) the process outcomes: ulcers, pulse examination done, dry or cracked skin, calluses or corns   2) patient outcomes:   dry or cracked skin
Lobach 1997	Local consensus processes + audit and feedback + reminders vs no intervention	Compliance rate:   Median baseline compliance levels during 6 months prior to the intervention: 21.2% vs 18.0%   Post intervention: 32.0% vs 15.6%   Absolute difference: 16.4%   Relative improvement: 105%   DE‐DC= 13.2     Foot examination:   Post intervention: 55.6% vs 30.0%   Absolute difference: 25.6%   Relative improvement: 85%     Complete physical examination:   Post intervention: 33.3% vs 6.7%   Absolute difference: 26.6%   Relative improvement: 397%     Chronic glycemia monitoring:   Post intervention: 57.4% vs 52.8%   Absolute difference: 4.6%   Relative improvement: 9%     Urine protein determination:   Post intervention: 73.3% vs 3.9%   Absolute difference: 69.4%   Relative improvement: 1779%     Cholesterol level:   Post intervention: 43.7% vs 13.4%   Absolute difference: 30.3%   Relative improvement: 226%     Ophthalmologic examination:   Post intervention: 18.8% vs 3.2%   Absolute difference: 15.6%   Relative improvement: 488%     Influenza vaccination:   Post intervention: 29.2% vs 22.7%   Absolute difference: 6.5%   Relative improvement: 29%	Not done	No p‐value given because of potential unit of analysis error     *Authors reported p=0.02 for compliance rate. Furthermore, only significant differences between intervention and control group were found for urine protein determination (p=0.01)
Mazze 1994	Distribution of educational materials + educational meetings + local consensus processes + reminders vs no intervention	Visits (mean±SD):*   Baseline: 3.0±1.2**   Post intervention: 4.3±1 vs 3.2±1.4 Absolute difference: 1.1   Relative improvement: 34%     Renal evaluation:   Baseline: 50%   Post intervention: 98% vs 50%   Absolute difference: 48%   Relative improvement: 96%     Retinal evaluation:   Baseline: 43%   Post intervention: 98% vs 43%   Absolute difference: 55%   Relative improvement: 127%     Education:   Baseline: 62%   Post intervention: 98% vs 63%   Absolute difference: 35%   Relative improvement: 56%     Health survey:   Baseline: 45%   Post intervention: 98% vs 45%   Absolute difference: 53%   Relative improvement: 118%	HbA1c (ref. ??)* (mean±SD)**:   Baseline: 10.2±2.8   Post intervention: 8.8±0.7 vs 10.3±0.7   Absolute difference: 1.5   Relative improvement: 15%	No p‐values were reported     *The process outcomes and patient outcomes were not reported separately at baseline
Mazzuca 1990	Group A (control group) postgraduate seminar vs   Group B: A+reminders vs   Group C: B+clinical materials vs   Group D: C+diabetes patient education service	GHb:   Post intervention B vs A: t=0.44 (n.s.)   Post intervention C vs B: 35% vs 21%   Absolute difference: 14%   Relative improvement: 67%   p<0.05   Post intervention D vs C: 21% vs 35%   Absolute difference: ‐14%   Relative improvement: ‐67%   p<0.05     Difference between groups (ANOVA): F=3.42 (p<0.05)     Fasting blood sugar (only physicians staffing morning clinics N=47):   B vs A: t=0.70 (n.s.)   C vs B: t=‐0.77 (n.s)   D vs C: t=0.14 (n.s)   Difference between groups: (ANOVA): F=0.25 (n.s.)     Home‐monitored blood glucose:   B vs A: t=1.65 (n.s.)   C vs B: t=1.38 (n.s.)   D vs C: t=‐0.84 (n.s.)   Difference between groups: (ANOVA): F=3.27 (p<0.05)     Diet:   B vs A: t=1.10 (n.s.)   C vs B: t=‐0.90 (n.s.)   D vs C: t=1.29 (n.s.)   Difference between groups: (ANOVA): F=1.02 (n.s.)     Oral hypoglycaemic agents:   B vs A: t=0.62 (n.s.)   C vs B: t=0.24 (n.s.)   D vs C: t=0.62 (n.s.)   Difference between groups: (ANOVA): F=0.75 (n.s.)	Not done
Palmer 1985	Educational materials + local consensus procedures + audit and feedback vs no intervention	Case‐variant score*:   Baseline mean variant score: 7 vs 6     Change in mean case variant score between baseline and experimental periods in control practices: +3.3   Difference in trend between experimental and control practices: ‐2.0   p=0.26 (SE=1.8)	Not done	(case‐variant score=(criteria not met/ criteria applicable)100)     **Possible ceiling effect: baseline variant scores are low
Pieber 1995	Educational materials + educational meetings + patient education vs no intervention	Not done	HbA1c (ref. 4.3‐6.1%):   Baseline (mean ± sd): 8.57±1.79 vs 8.77±2.08   Post intervention: 8.11±1.55 vs 9.03±1.79   Absolute difference: 0.92 [0.23‐1.61]   Relative improvement: 11%   DE‐DC= 0.72     Cholesterol (mmol/l):   Baseline: 6.47±1.31 vs 6.57±1.65   Post intervention: 6.07±1.01 vs 6.52±1.77   Absolute difference: 0.45 (n.s.)   Relative improvement: 7%   DE‐DC= 0.35     Triglycerides (mmol/l):   Baseline: 2.99±2.32 vs 2.62±1.79   Post intervention: 2.36±1.75 vs 2.79±2.53   Absolute difference: 0.43 [0.12‐0.84]   Relative improvement: 15%   DE‐DC= 0.80     BMI (kg/m²):   Baseline: 30.2±4.8 vs 30.2±4.7   Post intervention: 29.2±4.5 vs 30.3±4.9   Absolute difference: 1.1 [0.3‐1.9]   Relative improvement: 4%   DE‐DC= 1.1     Body weight (kg):   Baseline: 82.1±14.5 vs 81.8±13.1   Post intervention: 79.4±13.9 vs 82.1±13.6   Absolute difference: 2.7 [1.0‐4.3]   Relative improvement: 3%   DE‐DC= 3     Systolic blood pressure (mmHg):   Baseline: 161±20 vs 157±21   Post intervention: 144±21 vs 150±24   Absolute difference: 6 (n.s.)   Relative improvement: 4%   DE‐DC= 10     Diastolic blood pressure (mmHg):   Baseline: 92±11 vs 91±13   Post intervention: 81±10 vs 86±14   Absolute difference: 5 [0.3‐10.9]   Relative improvement: 6%   DE‐DC= 6     Foot care:   Callus formation:   Baseline: 78% vs 82%   Post intervention: 49% vs 82%   Absolute difference: 33%   Relative improvement: 40%   DE‐DC= 29     Interdigital cracks, interdigital fissures or mycosis   Baseline: 58% vs 53%   Post intervention: 49% vs 65%   Absolute difference: 16%   Relative improvement: 25%   DE‐DC= 21     Margins of the toe nails were cut back, or ingrown toe nails were cut out   Baseline: 87% vs 92%   Post intervention: 27% vs 92%   Absolute difference: 65%   Relative improvement: 71%   DE‐DC= 60	No p‐value given because of potential unit of analysis error     *Authors report significant differences (p=0.01), except for systolic blood pressure (p=0.11), diastolic blood pressure (p=0.05) and cholesterol (p=0.06).     For foot care significant changes were found in the intervention group, but changes remained unchanged in the intervention group
Pill 1998	Educational meetings + educational outreach visits vs no intervention	Attendance at practice over last 12 months:   Mean difference in intervention group (N=73): +0.192 (6.35)   Mean difference in control group (N=84): +1.96 (NA)	**Glyc‐Hb:   Hospital A :   Mean baseline values (SD): 11.70 (2.16) vs 12.06 (2.65)   Mean difference (time1‐time2) (N=56 vs 49): 0.998 (2.70) vs 1.62 (2.95)     Hospital B:   Mean baseline values (SD): 10.20 (1.35) vs 11.53 (1.74)   Mean difference (time1‐time2) (N=15 vs 27):   ‐0.447 (2.17) vs 0.311 (2.07)     Hospital A +B:   Mean difference (time1‐time2):   0.693 (2.65) vs 1.153 (2.73)     BMI (kg/m2):   Mean difference: 0.382 (2.44) vs 0.858 (3.73)     Weight (kg) (men):   Mean difference: ‐0.254 (5.56) vs ‐0.379 (7.41)     Weight (kg) (women):   Mean difference: 1.92 (4.55) vs 1.29 (4.93)     Systolic blood pressure (mmHg):   Mean difference: ‐1.47 (21.45) vs 3.12 (19.45)     Diastolic blood pressure ( mmHg):   Mean difference: ‐0.343 (11.56) vs 0.650 (10.81)     Measure of complications:   Mean difference: 0.291 (0.497) vs 0.273 (0.597)	No p‐value given because of potential unit of analysis error     In hospital B Glyc‐Hb was significant different in both groups at baseline for the other outcomes it is not clear     **The reference ranges for glyco‐Hb over time were revised by the laboratories during the study period, thus giving a potentially false impression of overall improvement if the raw data alone were inspected.     Authors reported no significant differences in changes over time between both groups.   Only for one item with regard to health status (SF‐36) a sign difference over time was found:   physical functioning, as measured by self‐reports of limitations to everyday activities:   P=0.02   (women p=0.03)   (men p=0.31)
Ward 1996	Educational materials + educational outreach visits + audit and feedback by interview vs educational materials + postal feedback	Group 1=doctor interview   Group 2=nurse interview   Group 3=control group   History:   Duration of known diabetes recorded:   Baseline: 56.9% vs 33.9% vs 31.1%   Post intervention: 60.8% vs 38.0% vs 31.1%   Absolute difference group 1: 22.8%   Absolute difference group 2: 6.9%   Relative improvement group 1: 95%   Relative improvement group 2: 22%   DE‐DC group 1= 3.9   DE‐DC group 2= 4.1   * No significant changes within groups     Dietary inquiry and advice:   Baseline: 60.0% vs 43.0% vs 43.7%   Post intervention: 64.6% vs 55.4% vs 44.4%   Absolute difference group 1: 20.2%   Absolute difference group 2: 11.0%   Relative improvement group 1: 45%   Relative improvement group 2: 25%   DE‐DC group 1= 3.9   DE‐DC group 2= 11.7   * Only significant change within group 2: p<0.05     Annual physical examination   Blood pressure   Baseline: 86.2% vs 81.0% vs 85.9%   Post intervention: 90.0% vs 85.1% vs 88.1%   Absolute difference group 1: 1.9%   Absolute difference group 2: ‐3.0%   Relative improvement group 1: 2%   Relative improvement group 2:‐3%   DE‐DC group 1= 1.6   DE‐DC group 2= 1.9   * No significant changes within groups     Eye examination (or referral to ophthalmologist)   Baseline: 23.1% vs 19.8% vs 29.6%   Post intervention: 42.3% vs 40.5% vs 31.1%   Absolute difference group 1: 11.2%   Absolute difference group 2: 9.4%   Relative improvement group 1: 36%   Relative improvement group 2: 30%   DE‐DC group 1= 7.7   DE‐DC group 2= 19.2   * Significant changes within group 1 (p<0.01) and within group 2 (p<0.001)     Body weight   Baseline: 47.7% vs 38.0% vs 35.6%   Post intervention: 67.7% vs 46.3% vs 43.3%   Absolute difference group 1: 24.4%   Absolute difference group 2: 3.0%   Relative improvement group 1: 56%   Relative improvement group 2: 7%   DE‐DC group 1= 12.3   DE‐DC group 2= 0.6   * Significant changes within group 1 (p<0.001)     Feet examined:   Pulses:   Baseline: 18.5% vs 7.4% vs 15.6%   Post intervention: 38.5% vs 26.4% vs 15.6%   Absolute difference group 1: 22.9%   Absolute difference group 2: 10.8%   Relative improvement group 1: 147%   Relative improvement group 2: 69%   DE‐DC group 1= 20.0   DE‐DC group 2= 19.0   * Significant changes within group 1 (p<0.001) and within group 2 (p<0.0001)     Sensation:   Baseline: 9.2% vs 9.1% vs 10.4%   Post intervention: 26.2% vs 20.7% vs 11.9%   Absolute difference group 1: 14.3%   Absolute difference group 2: 8.8%   Relative improvement group 1: 120%   Relative improvement group 2: 74%   DE‐DC group 1= 15.5   DE‐DC group 2= 10.1   * Significant changes within group 1 (p<0.001) and within group 2 (p<0.05)     Nails:   Baseline: 14.6% vs 8.3% vs 10.4%   Post intervention: 20.0% vs 12.4% vs 8.1%   Absolute difference group 1: 11.9%   Absolute difference group 2: 4.3%   Relative improvement group 1: 147%   Relative improvement group 2: 53%   DE‐DC group 1= 7.8   DE‐DC group 2= 6.4   * No significant changes within groups     Reflexes:   Baseline: 4.6% vs 5.0% vs 5.2% Post intervention: 21.5% vs 17.4% vs 8.1%   Absolute difference group 1: 13.4%   Absolute difference group 2: 9.3%   Relative improvement group 1: 165%   Relative improvement group 2: 115%   DE‐DC group 1= 14.0   DE‐DC group 2= 9.5   * Significant changes within group 1 (p<0.001) and within group 2 (p<0.01)     HbA1 (1 per 8 months):   Baseline: 36.9% vs 28.9% vs 46.7%   Post intervention: 54.6% vs 44.6% vs 40.7%   Absolute difference group 1: 13.9%   Absolute difference group 2: 3.9%   Relative improvement group 1: 34%   Relative improvement group 2: 10%   DE‐DC group 1= 23.7   DE‐DC group 2= 21.7   * Significant changes within group 1 (p<0.001) and within group 2 (p<0.05)     Blood glucose (2 per 8 months):   Baseline: 46.2% vs 48.8% vs 36.3%   Post intervention: 58.5% vs 52.1% vs 37.8%   Absolute difference group 1: 20.7%   Absolute difference group 2: 14.3%   Relative improvement group 1: 55%   Relative improvement group 2: 38%   DE‐DC group 1= 10.8   DE‐DC group 2= 1.8   * Significant changes within group 1 (p<0.05)     Cholesterol (1 per 8 months):   Baseline: 26.2% vs 19.8% vs 23.7%   Post intervention: 39.2% vs 25.6% vs 25.9%   Absolute difference group 1: 13.3%   Absolute difference group 2: ‐0.3%   Relative improvement group 1: 51%   Relative improvement group 2:   ‐1%   DE‐DC group 1= 10.8   DE‐DC group 2= 3.6   * Significant changes within group 1 (p<0.05)     Triglycerides (1 per 8 months):   Baseline: 21.5% vs 19.0% vs 20.7%   Post intervention: 34.6% vs 24.8% vs 23.0%   Absolute difference group 1: 11.6%   Absolute difference group 2: 1.8%   Relative improvement group 1: 50%   Relative improvement group 2: 8%   DE‐DC group 1= 10.8   DE‐DC group 2= 3.5   * Significant changes within group 1 (p<0.01)     Overall modified Adequate Competent Care (ACC) score (SD):   Baseline: 4.3 (2.3) vs 3.5 (2.0) vs 3.7( 2.0)   Post intervention: 6.1 (3.1) vs 4.8 (2.9) vs 4.0 (2.2)   Absolute difference group 1: 2.1   Absolute difference group 2: 0.7%   Relative improvement group 1: 53%   Relative improvement group 2: 20%   DE‐DC group 1= 1.5   DE‐DC group 2= 1.0   * Significant difference between groups p<0.0001     Contrast ACC‐score:     No interview vs interview: p<0.001   No interview vs doctor interview: p<0.001   No interview vs nurse interview: p<0.01   Doctor interview vs nurse interview: N.S.	Not done	Other reported items:   With regard to history:   alcohol intake inquiry and advice, exercise inquiry and advice, smoking inquiry and advice and impotence/vaginitis inquiry and advice showed significant differences within the doctor interview group and also within the nurse interview group     With regard to blood tests:   creatinine showed significant differences within the doctor interview group (p<0.0001) and within the nurse interview group (p<0.01)     With regard to urinalysis:   glucose and nitrite showed no significant differences within groups. Only protein showed a slight significant difference within the nurse interview group (p<0.05)
Carlson 1991	Educational meetings + local consensus processes to identify problems and to create plans to improve diabetes care   + educational outreach visits   vs no intervention	Patients height noted in case notes during previous year:   Post intervention: 73% vs 50%   Absolute difference: 23%   Relative improvement: 46%     HbA1c value measured during previous year:   Post intervention: 27% vs 8%   Absolute difference: 19%   Relative improvement: 238%     Eye examination performed during previous year:   Post intervention: 40% vs 28%   Absolute difference: 12%   Relative improvement: 43%	Of a 20% secondary sample (806 patients) 566 patients had their HbA1c value measured     HbA1c (mean±SD):   Post intervention: 8.1±1.8 vs 7.8±1.6   Absolute difference: ‐0.3   Relative improvement:   ‐4%	No p‐value given because of potential unit of analysis error     *Authors report significant differences for patients height noted in case notes (p<0.01), HbA1c value measured (p<0.001) and eye examination performed p<0.01.   For HbA1c they report that both groups have a similar degree of metabolic control, p‐value is not reported.

Study	Comparison	Effect on practice	Effect on patient	Notes
Branger 1999	Changes in medical record systems (electronic communication between different physicians who both provide diabetic care to the same diabetic patients) vs no intervention	Patient contacts with GP (average number per patient per year):   Baseline: 12 vs 12   Post intervention: 14 vs 14   Absolute change: 0   Relative improvement: 0%   DE‐DC= 0     Patient contacts with consultant (average number per patient per year):   Baseline: 4 vs 4   Post intervention: 4 vs 4   Absolute change: 0   Relative improvement: 0%   DE‐DC= 0     Letters from GP to consultant:   (average number per patient per year):   Baseline: 0.2 vs 0.2   Post intervention: 0.7 vs 0.2   Absolute change: 0.5   Relative improvement: 250%   DE‐DC= 0.5     Letters from consultant to GP:   (average number per patient per year):   Baseline: 0.5 vs 0.5   Post intervention: 0.4 vs 1.6   Absolute change: 1.2   Relative improvement: 300%   DE‐DC= 1.2     Recorded items per patient:     Creatinine level:   Baseline: 0.2 vs 0.2   Post intervention: 0.5 vs 0.4   Absolute change: 0.1   Relative improvement: 25%   DE‐DC= 0.1     Proteinuria:   Baseline: 0.1 vs 0.2   Post intervention: 0.1 vs 0.5   Absolute change: 0.4   Relative improvement: ‐80%   DE‐DC= ‐0.3     Assessment ophthalmologist:   Baseline: 0.2 vs 0.3   Post intervention: 0.3 vs 0.3   Absolute change: 0.0   Relative improvement: 0%   DE‐DC= 0.1     Glucose level:   Baseline: 1.0 vs 1.6   Post intervention: 1.9 vs 1.8   Absolute change: 0.1   Relative improvement: 6%   DE‐DC= 0.7     HbA1c:   Baseline: 0.0 vs 0.0   Post intervention: 0.8 vs 0.2   Absolute change: 0.1   Relative improvement: 300%   DE‐DC= 0.6   Fructosamine:   Baseline: 0.1 vs 0.0   Post intervention: 0.2 vs 0.0   Absolute change: 0.2   Relative improvement: N/A   DE‐DC= 0.1     Blood pressure:   Baseline: 0.6 vs 1.3   Post intervention: 1.9 vs 1.4   Absolute change: 0.5   Relative improvement: 36%   DE‐DC= 1.2     Cholesterol level:   Baseline: 0.1 vs 0.1   Post intervention: 0.7 vs 0.4   Absolute change: 0.3   Relative improvement: 75%   DE‐DC= 0.3     Triglyceride level:   Baseline: 0.0 vs 0.0   Post intervention: 0.2 vs 0.1   Absolute change: 0.1   Relative improvement: 100%   DE‐DC= 0.1     Weight:   Baseline: 0.3 vs 0.2   Post intervention: 2.1 vs 0.5   Absolute change: 1.6   Relative improvement: 320%   DE‐DC= 1.5	Not done	No p‐value given because of potential unit of analysis error     The authors reported a significant increase in the number of letters sent by the consultant to the intervention GPs when compared to the control group (p<0.01). Furthermore the patient records in the intervention group contained significantly more data on Hba1c, fructosamine, blood pressure, cholesterol, triglyceride and weight.     The change in HbA1c is not reported in this review because both measurements were assessed after implementation of the intervention (first half and second half of 1994, as the intervention was implemented in 1994)
Day 1992	Revision of professional roles + changes to the setting + a learner‐centred counselling approach was adopted allowing patients to identify problems and agree potential solutions vs no intervention	Not done	HbA1c (mean±SEM) (N=174 vs 154):   Baseline: 11.9±2.3 vs 12.2±2.3   Post intervention: 9.9±1.9 vs 11.3±2.6   Absolute difference: 1.4   Relative improvement: 12%   DE‐DC= 1.1	No p‐value given because of potential unit of analysis error     The authors reported a significant fall in HbA1 in the intervention group (p<0.0001) and in the control group (p<0.01) during the period of 1985 to 1988     In the study the effect of the intervention was also measured in a group of patients aged >65 studied from 1986‐1988 (N=144) (baseline measurement is missing)   and in the clinic population as a whole using cross sectional analysis in 1985 and in 1988 (N=700)     **The initial mean values of patients in group 4 were identical to those in group 3. The mean HbA1 value showed in 1988 a significant larger decrease in group 3 than in group 4
de Sonnaville 1997	A clinical multidisciplinary team (general practitioner, diabetes nurse educator, dietician, podiatrist, diabetologist) + formal integration of services (general practitioner was supported by laboratory) + arrangements for follow up + communication and case discussion between distant health professionals + changes to the setting /site of service delivery + changes in medical records systems + patient education vs no intervention	Not done	Fasting glucose (mmol/l)   (mean±SD):   Baseline: 8.9±2.5 vs 9.6±3.4   Post intervention: 8.1±2.5   vs 9.8±2.9   Absolute difference: 1.7   Relative improvement: 17%   DE‐DC= 1.0     HbA1c (%) (ref 4.3‐6.1%):   Baseline: 7.4±1.6 vs 7.4±1.9   Post intervention: 7.0±1.3 vs 7.6±1.5   Absolute difference: 0.6   Relative improvement: 8%   DE‐DC= 0.8     BMI (kg/m2):   Baseline: 28.7±4.6 vs 26.8±4.0   Post intervention: 29.0±4.6 vs 26.5±3.8   Absolute difference: 2.5   Relative improvement:   ‐9%   DE‐DC= ‐0.6     HbA1c >8.5%:   Baseline: 21.4% vs 23.5%   Post intervention: 11.7% vs 27.9%   Absolute difference: 16.2%   Relative improvement:   58%   DE‐DC= 14.1%     HbA1c <7.0%:   Baseline: 43.4% vs 54.4%   Post intervention: 54.3% vs 44.1     Total cholesterol (mmol/l):   Baseline: 6.1±1.3 vs 5.9±1.0   Post intervention: 5.8±1.1   vs 5.9±1.0   Absolute difference: 0.1   Relative improvement:   2%   DE‐DC= 0.3     HDL (mmol/l):   Baseline: 1.21±0.36 vs 1.14±0.35   Post intervention: 1.16±0.32 vs 1.13±0.37   Absolute difference: 0.03   Relative improvement:   3%   DE‐DC= ‐0.04     Triglycerides (mmol/l):   Baseline: 2.12±1.64 vs 2.01±1.46   Post intervention: 1.96±1.72 vs 2.03±1.55   Absolute difference: 0.07   Relative improvement:   3%   DE‐DC= 0.18     Systolic blood pressure (mmHg):   Baseline: 146.9±20.9 vs 155.4±24.0   Post intervention: 147.7±23.5 vs 155.3±22.9   Absolute difference: 7.6   Relative improvement:   5%   DE‐DC= ‐0.9     Diastolic blood pressure (mmHg):   Baseline: 87.4±10.8 vs 88.8±11.4   Post intervention: 83.0±12.6 vs 85.3±11.4   Absolute difference: 2.3   Relative improvement:   3%   DE‐DC= 0.9	No p‐value given because of potential unit of analysis error     baseline characteristics are comparable except for gender, fasting glucose, BMI, HDL‐cholesterol and blood pressure     For the comparison between study and control population corrected deltas (=[baseline value‐final value]/baseline value) were calculated. The main endpoint (corrected delta HbA1c) was adjusted for differences in baseline characteristics applying linear regression analysis.     **The authors reported significant differences in changes between both groups for fasting glucose (p=0.004), HbA1c (p=0.002), BMI (p=0.000), total cholesterol (p=0.002).   Differences in change in blood glucose lowering therapy were also reported mainly due to an increase in insulin in the intervention group
Halbert 1999	Arrangements for follow up (multiple reminders to patients) vs single reminder	Diabetes eye exam rates:   Baseline: Not available   Post intervention first 6 months:   25.4 vs 24.3   p=0.074   Post intervention second 6 months:   11.6 vs 11.2   p=0.306   Post intervention full year:   37.0 vs 35.4   p=0.0203	Not done
Hawkins 1979	Revision of professional rules   (A clinical pharmacist was responsible for follow‐up care of patient with diabetes) vs no intervention	Not done	Fasting blood glucose (mg/dl)   Baseline: 192 (±46) vs 182 (±39)   In mmol/l:   10.7 (±2.6) vs 10.1 (±2.2)   Post intervention:   184 (±42) vs 189 (±49)   In mmol/l:   10.2 (±2.3) vs 10.5 (±2.7)   Absolute difference: 0.3   Relative improvement: 3%   DE‐DC= 0.9	*The baseline fasting blood glucose was significant different between both groups (p<=0.05).   Analysis of covariance showed the post intervention assessments fell short of achieving significance (p<0.058)
Jaber 1996	Revision of professional roles   (all diabetes‐related management aspects were solely provided by a pharmacist) + patient education vs no intervention	Not done	Fasting plasma glucose (mmol/l)   Baseline: 11.1±4.0 vs 12.7±4.7   Post intervention: 8.5±2.3 vs 11.0±3.9   Absolute difference: 2.5   Relative improvement: 23%   DE‐DC= 0.9     Within the intervention group the change was sign p<0.05   The post intervention value was sign different between groups p<0.05     Glycated haemoglobin (%) (ref 4.0‐8.0%):   Baseline: 11.5±2.9 vs 12.2±3.5   Post intervention: 9.2±2.1   vs 12.1±3.7   Absolute difference: 2.9   Relative improvement: 24%   DE‐DC= 2.2     Within the intervention group the change was sign p<0.05   The post intervention value was sign different between groups p<0.05     The change in glycated haemoglobin was sign different between groups p<0.05	No significant differences at baseline     No significant changes in blood pressure, body weight, serum lipid measurements and renal function parameters + quality of life were noted between or within groups.   Values are not reported.
Sadur 1999	Clinical multidisciplinary teams + skill mix changes + case management + patient education vs no intervention	Not done	HbA1c (ref. ??) (N=82 vs 74):   Baseline: 9.48 vs 9.55   Post intervention (6 months): 8.18 vs 9.33 (adjusted p‐value<0.0001)   Absolute difference (9 months): 1.15   Relative improvement: 12%   DE‐DC= 1.08   Adjusted p‐value for difference in change: p<0.001     Hospital discharge rates (per 1000 months):   Baseline (year before intervention):   17 vs 19   Post intervention (12 months after intervention period)   16 vs 28   Absolute difference: 12   Relative improvement: 43%   DE‐DC= 10   Adjusted p‐value=0.04     Outpatient physician visit rates (per 1000 months):   Baseline (6 months before intervention):   310 vs 360   During 6 months of intervention:   250 vs 340   Post intervention (12 months after intervention period)   270 vs 370   Absolute difference: 100   Relative improvement: 27%   DE‐DC= 50   Adjusted p‐value=0.06     Outpatient non‐physician visit rates (per 1000 months):   Baseline (6 months before intervention):   100 vs 100   During 6 months of intervention:   810 vs 170   Post intervention (12 months after intervention period)   180 vs 270   Absolute difference: 90   Relative improvement: 33%   DE‐DC= 90   Adjusted p‐value=0.001	No significant differences at baseline     *p‐values are adjusted for baseline values
Smith 1987	Arrangements for follow up +   patient education + appointment reminders for patients vs no intervention	Kept scheduled visits:   Post intervention: 4.13±2.88 vs 3.61±2.46   Absolute difference: 0.52   Relative improvement: 14%   P=0.00062     Prescription refills:   Post intervention: 1.00 vs 0.94   Absolute difference: 0.06   Relative improvement: 6%   P=N.S.     Walk‐in visits:   Post intervention: 0.72 vs 0.63   Absolute difference: 0.09   Relative improvement: 14%   P=N.S.     Total contacts:   Post intervention: 5.84±4.06 vs 5.18±3.60   Absolute difference: 0.66   Relative improvement: 13%   P=0.0105     Visit failures:   Post intervention: 1.13 vs 1.16   Absolute difference: ‐0.03   Relative improvement: 3%   P=NS     Total scheduled visits (kept and failed)   Post intervention: 5.26±3.39 vs 4.77±2.84   Absolute difference: 0.49   Relative improvement: 10%   P=0.040	Mean hospitalisations per patient per month:   Patients with low risk**:   0.030 vs 0.029   Absolute difference: ‐0.001   Relative improvement: ‐3%     Patients with medium risk:   0.039 vs 0.040   Absolute difference: 0.001   Relative improvement: 3%     Patients with high risk:   0.068 vs 0.073   Absolute difference: 0.005   Relative improvement: 7%     Overall intervention effect on hospitalisations: P=0.8	No sign difference between both groups at baseline     *Previous studies at the center identified characteristics associated with nonelective hospitalisation of ambulatory patients taking antidiabetic agents
Sullivan 1991	Interrupted Time Series (ITS):     Clinical multi‐disciplinary teams   (A joint GP/nurse review system) + arrangements of follow‐up	Percentage of patients with recording examinations during 1983‐1988. In 1986 the GPs were joined by a practice nurse (intervention)     Weight:   1983: 76   1984: 61   1985: 58   1986: 68   1987: 77   1988: 86     Blood pressure:   1983: 80   1984: 66   1985: 64   1986: 72   1987: 84   1988: 90     Visual acuity:   1983: 75   1984: 52   1985: 56   1986: 70   1987: 77   1988: 86     Funduscopy:   1983: 62   1984: 41   1985: 64   1986: 76   1987: 72   1988: 77     Foot examination:   1983: 66   1984: 48   1985: 56   1986: 77   1987: 81   1988: 87     HbA1c:   1983: 71   1984: 59   1985: 52   1986: 66   1987: 81   1988: 86	Not done	No results of statistical analyses were reported by the authors

Study	Comparison	Effect on practice	Effect on patient	Notes
Aubert 1998	Educational materials (detailed management algorithms) +   revision of professional roles (nurse case management) +   arrangements for follow‐up +   patient education vs no intervention	Renal assessment:     Dipstick test:   Baseline: 68.6% vs 70.0%   Post intervention: 51.0% vs 58.0%   Absolute difference: 7%   Relative improvement: ‐12%   DE‐DC=‐5.6%     Quantitative protein/microalbumin test:   Baseline: 33.3% vs 28.1%   Post intervention: 80.7% vs 51.9%   Absolute difference: 28.8%   Relative improvement: 55%   DE‐DC=23.6%   p<0.05	HbA1c (%) (ref??‐6.1%):   Mean change: ‐1.7 vs   ‐0.6   DE‐DC= ‐1.1 [‐1.62 to 0.58]   p <0.001     Mean fasting blood glucose (mmol/l):   Mean change: ‐2.68 vs   ‐0.80   DE‐DC= ‐1.88 [‐3.12 to 0.64]   p=0.003     Systolic blood pressure (mmHg):   Mean change: 1.9 vs 6.1   DE‐DC= ‐4.2 [‐9.81 to 1.41]   p >0.2     Diastolic blood pressure (mmHg):   Mean change: ‐0.8 vs 1.5   DE‐DC= ‐2.3 [‐5.79 to 1.19]   p >0.2     Weight (kg):   Mean change: ‐0.21 vs   ‐0.4   DE‐DC= ‐0.19 [‐1.6 to 2.0]   p >0.2     Serum cholesterol (mmol/l):   Mean change: ‐0.31 vs   ‐0.19   DE‐DC= ‐0.12 [‐0.56 to 0.31]   p >0.2     Serum triglycerides (mmol/l):   Mean change: ‐0.24 vs 0.11   DE‐DC= ‐0.35 [‐1.47 to 0.76]   p >0.2     Serum HDL‐cholesterol (mmol/l):   Mean change: 0.05 vs 0.02   DE‐DC= 0.03 [‐0.06 to 0.12]   p >0.2     Serum LDL‐cholesterol (mmol/l):   Mean change: ‐0.16 vs   ‐0.26   DE‐DC 0.11 [‐0.21 to 0.42]   p >0.2     Self‐reported health status score*:   Mean change: 0.47 vs 0.20   DE‐DC= 0.27 [‐0.03 to 0.57]   p =0.02   (p‐value adjusted such that it is possible for it to be inconsistent with the CI, which is not adjusted)	At baseline the intervention group had fewer members of ethnic minority groups, more smokers, and more insulin‐treated patients.     p‐value for comparison of change scores adjusted for the baseline values of the covariates     Self reported health status was assessed by Behavioural Risk Factor Surveillance System     Patients lost to follow‐up did not sign differ by sex, type of diabetes, therapeutic regimen, baseline mean HbA1c or treatment group. However, patients 18 to 44 years of age were more likely than patients 45 years of age and older to be lost to follow up (52 % compared with 23%; p=0.002) Also non‐white patients were more likely than white patients lost to follow up (41 % compared with 26%; p=0.10)     *** If intention to treat analysis were used to account for patients who were lost to follow up, the intervention group continued to show a statistically significantly greater improvement in HbA1c compared with usual care group
Boucher 1987	Educational materials + educational meetings + arrangements for follow up +   communication and case discussion between distant health professionals + changes in medical record systems vs no intervention	Completion of clinical review:   Post intervention: 40.1% vs 15.0%   Absolute difference: 25.1%   Relative improvement: 167%   DE‐DC=NA	Glycosylated haemoglobin (upper limit of normal is 10.5%) (mean±SD):   Baseline: 13.4 ± 2.9 vs   12.6 ± 3.2   Post intervention I: 11.4 ± 2.3 vs 12.5 ± 2.6   Mean difference: 1.1   Relative improvement: 9%   DE‐DC=1.9     In the intervention group 94 of the 142 patients who entered the study had follow‐up data. In the control group 44% of 200 patients had follow‐up data	No p‐value given because of potential unit of analysis error     No sign difference in GHQ values between both groups at baseline. For completion of clinical review no baseline values reported     Authors reported a significant fall in GHb values in the intervention group (p<0.001) in contrast with the control group in which the change was not significant. For the comparison of both groups with regard to the completion of clinical review no   statistical test was done     *Patients in control group were sign younger and were sign more treated by diet+OHAs or diet+insulin
Deeb 1988	Educational materials + educational meetings + educational outreach visits +   clinical multidisciplinary team + patient education vs no intervention	Documentation of search for complication in clinical record:   Intervention group (N=399)   Control group (N=237)     Retinopathy   History   Baseline: 28% vs 5% (p<0.001)   Post intervention: 38% vs 7%   Absolute difference: 31%   Relative improvement: 443%   DE‐DC=8     Exam   Baseline: 11% vs 24%   Post intervention: 46% vs 23%   Absolute difference: 23%   Relative improvement: 100%   DE‐DC=36     Referral   Baseline: 9% vs 21%   Post intervention: 43% vs 33%   Absolute difference: 10%   Relative improvement: 30%   DE‐DC=22     Lower‐extremity care   History   Baseline: 45% vs 11%   Post intervention: 73% vs 17%   Absolute difference: 56%   Relative improvement: 329%   DE‐DC=22     Exam   Baseline: 66% vs 27%   Post intervention: 94% vs 41%   Absolute difference: 53%   Relative improvement: 129%   DE‐DC=14     Hypertension   Blood pressure taken   Baseline: 100% vs 99%   Post intervention: 100% vs 99%   Absolute difference: 1%   Relative improvement: 1%   DE‐DC=0     Hypertension diagnosed   Baseline: 66% vs 60%   Post intervention: 68% vs 64%   Absolute difference: 4%   Relative improvement: 6%   DE‐DC=‐2     Last blood pressure reading   >140 or >90 mmHg   Baseline: 64% vs 38%   Post intervention: 56% vs 50%   Absolute difference: 6%   Relative improvement: 12%   DE‐DC=‐20     Last blood pressure reading   >160 or >95 mmHg   Baseline: 21% vs 20%**   Post intervention: 17% vs 20%   Absolute difference: ‐3%   Relative improvement: ‐15%   DE‐DC=‐4	Not done	No p‐value given because of potential unit of analysis error     Differences at baseline were not tested     The mean age, duration of diabetes and sex distribution were different between the intervention and control group at 0.05 level     **249 of 648 patients from the first census were no longer active in the post intervention period (defined as seen during the year). At the control sites, the same sort of patient turnover seemed apparent   Two of the centres with 449 of the original patients were able to follow up on clinical dropouts. For those lost to follow‐up, there was no difference in age, race, sex, duration of diabetes or treatment compared with those followed the 2nd year     The authors reported significant changes within the intervention group for:   1) history (p<0.01), exam (p<0.001) and referral (p<0.001) for retinopathy   2) history, exam for lower‐extremity care( p<0.001)   3) last blood pressure reading >140 or >90 mmHg (p<0.05)     In the control group significant changes were found for:   1) referral for retinopathy (p<0.01)   2) history, exam for lower‐extremity care (p<0.05)   3) Last blood pressure reading >140 or >90 mmHg (p<0.05).
Hartmann 1995	Educational materials + educational meetings + audit and feedback + changes in medical record systems vs no intervention	Documentation of diabetes‐relevant data (% patients with >=1 measurement documented per year)     Funduscopy   Baseline: 8.4% vs 5.5%   Post intervention: 32.2% vs 13.4%   Absolute difference: 18.8%   Relative improvement: 71%   DE‐DC=15.9%     Pallaesthesia   Baseline: 0.4% vs 4.9%   Post intervention: 35.1% vs 4.9%   Absolute difference: 30.2%   Relative improvement: 622%   DE‐DC=34.7%     Albuminuria   Baseline: 1.2% vs 8.5%   Post intervention: 19.7% vs 12.2%   Absolute difference: 7.5%   Relative improvement: 61%   DE‐DC=14.8%     Serum creatinine   Baseline: 62.8% vs 72.6%   Post intervention: 71.1% vs 62.0%   Absolute difference: 9.1%   Relative improvement: 15%   DE‐DC=18.9%     Total cholesterol   Baseline: 57.3% vs 76.8%   Post intervention: 61.5% vs 64.0%   Absolute difference: 2.5%   Relative improvement: ‐4%   DE‐DC=17%     Triglyceride   Baseline: 30.1% vs 68.9%   Post intervention: 47.2% vs 60.4%   Absolute difference: 13.2%   Relative improvement: ‐22%   DE‐DC=25.6%     HDL cholesterol   Baseline: 4.6% vs 21.9%   Post intervention: 14.3% vs 8.5%   Absolute difference: 5.8%   Relative improvement: 68%   DE‐DC=23.1%     Documentation of diabetes‐relevant data (% patients with >=1 measurement documented per quarter)     Blood glucose   Baseline: 87.9% vs 70.1%   Post intervention: 78.7% vs 67.1%   Absolute difference: 11.6%   Relative improvement: 17%   DE‐DC=‐6.2%     Blood pressure   Baseline: 72.0% vs 62.8%   Post intervention: 69.9% vs 65.2%   Absolute difference: 4.7%   Relative improvement: 7%   DE‐DC=‐4.5%     HbA1c   Baseline: 27.6% vs 24.4%   Post intervention: 26.8% vs 32.3%   Absolute difference: ‐5.5%   Relative improvement: ‐17%   DE‐DC=‐8.7%     Body weight   Baseline: 36.0% vs 18.3%   Post intervention: 35.1% vs 12.2%   Absolute difference: 22.9%   Relative improvement: 22%   DE‐DC=5.2%     Glucose self‐measurement (blood or urine)   Baseline: 7.9% vs 21.3%   Post intervention: 11.3% vs 17.1%   Absolute difference: ‐5.8%   Relative improvement: ‐34%   DE‐DC=7.6%	Not done	No p‐value given because of potential unit of analysis error     A possible ceiling effect was identified by the reviewers:   In the initial evaluation blood pressure and blood glucose measurements were documented quite frequently in both groups; these values had not changed sign at re‐evaluation. Compared to other studies the number of measurements was high     **The authors reported significant differences in changes between both groups for all items documented yearly.   For items documented quarterly no significant differences were found except for glucose self‐measurement
Hoskins 1992	Educational materials + educational outreach visits + arrangements for follow up (prompting of patient and physician by nurse) vs routine care by GP care vs routine care by specialist diabetic clinic     Comparison 1: Shared care vs routine care by GP   Comparison 2: Shared care vs routine care by specialist diabetic clinic	Attendance rates (%):   Initial assessment: 100% vs 100% vs 100%   Post intervention (after 12 months)   72% vs 35% vs 53%   Absolute difference 1: 37%   Absolute difference 2: 19%   Relative improvement 1: 106%   Relative improvement 2: 36%   DE‐DC (1)=37   DE‐DC (2)=19     Complication assessment after 12 months: 61% vs 57% vs N/A   Absolute difference 1: 4%   Relative improvement 2: 7%   DE‐DC=4     * Analysis confirmed that the only significant predictor for continuing attendance at 12 months was the assigned treatment group (p<0.036)     Completeness of documentation (proportion of clinical information sent back by the GP to the clinic according to the protocol)     HbA1c:   Post intervention: 66.0% vs 45.6% vs 98.4   Absolute difference 1: 20.4%   Absolute difference 2: ‐32.4%   Relative improvement 1: 45%   Relative improvement 2: ‐33%     Weight:   Post intervention: 93.5% vs 70.6% vs 98.3   Absolute difference 1: 22.9%   Absolute difference 2: ‐4.8%   Relative improvement 1: 32%   Relative improvement 2: ‐5%     Blood pressure:   Post intervention: 94.8% vs 89.7% vs 92.7   Absolute difference 1: 5.1%   Absolute difference 2: 2.1%   Relative improvement 1: 6%   Relative improvement 2: 2%	HbA1c (%) (ref 3.5‐6.0%)   (mean ± SD):   Baseline: 8.5 ± 2.2   vs 8.4 ± 2.6 vs 8.9 ± 2.5   Post intervention:   6.6 ± 1.6 vs 6.9 ± 1.3 vs 7.3 ± 1.6   Absolute difference 1: 0.3   Absolute difference 2: 0.6   Relative improvement 1: 4%   Relative improvement 2: 10%   DE‐DC (1)=0.4   DE‐DC (2)=0.3     Systolic blood pressure (mmHG) (mean ± SD):   Baseline: 145 ± 24   vs 148 ± 23 vs 150 ± 23   Post intervention:   130 ± 25 vs 136 ± 14 vs 133 ± 19   Absolute difference 1: 6   Absolute difference 2: 3   Relative improvement 1: 4%   Relative improvement 2: 2%   DE‐DC (1)=3   DE‐DC (2)=‐2     Diastolic blood pressure (mmHg) (mean ± SD):   Baseline: 88 ± 13 vs 90 ± 15 vs 90 ± 13   Post intervention: 81 ± 11 vs 81 ± 11 vs 81 ± 13   Absolute difference 1: 0   Absolute difference 2: 0   Relative improvement 1: 0%   Relative improvement 2: 0%   DE‐DC (1)=‐2   DE‐DC (2)=‐2     Weight (kg) (mean ± SD):   Baseline: 77 ± 16 vs 77 ± 18 vs 80 ± 20   Post intervention: 75 ± 14   vs 76 ± 19 vs 79 ± 19   Absolute difference 1: 1   Absolute difference 2: 4   Relative improvement 1: 1%   Relative improvement 2: 5%   DE‐DC (1)=1   DE‐DC (2)=1     All three groups showed a comparable improvement for Hba1c, systolic and diastolic blood pressure (p<0.05).     Weight decreased marginally in all three groups but this reached statistical significance only in the shared care group (p<0.04)
Hurwitz 1993	Educational meetings + arrangements for follow‐up   + changes in medical record systems vs no intervention	% of patients without doctor diabetes review during study period:   Post intervention: 3.4% vs 15.2%   Absolute difference: 11.8%   Relative improvement: 78%   p=0.013     Mean No of doctor diabetes reviews per patient per year (SD):   Post intervention: 3.0 (3.8) vs 2.4 (1.3)   Absolute difference: 0.6   Relative improvement: 25%   p=NS     Mean No of diabetes reviews per patient per doctor (SD):   Post intervention: 3.2 (1.9) vs 2.2 (2.0)   Absolute difference: 1.0   Relative improvement: 45%   p<0.001     Mean No of urine tests for albumin per patient per year (SD):   Post intervention: 3.0 (4.5) vs 2.3 (1.4)   Absolute difference: 0.7   Relative improvement: 30%   p=0.03     Mean No of plasma glucose estimations per patient per year (SD):   Post intervention: 3.1 (4.5) vs 2.3 (1.4)   Absolute difference: 0.8   Relative improvement: 35%   p=0.003     Mean No of glycated haemoglobin estimations per patient per year (SD):   Post intervention: 2.4 (3.8) vs 0.9 (0.9)   Absolute difference: 1.5   Relative improvement: 167%   p<0.001     % of patients referred to dietician:   Post intervention: 34% vs 41%   Absolute difference: 7%   Relative improvement: ‐17%   p=NS     % of patients referred to chiropodist:   Post intervention: 8 % vs 13%   Absolute difference: 5%   Relative improvement: ‐38%   p=NS	Mean random plasma glucose (mmol/l) (SD):   Baseline: 9.6 (3.8) vs 9.9 (4.1)   Post intervention: 11.2 (4.2) vs 11.2 (4.2)   Absolute difference: 0   Relative improvement: 0%   DE‐DC=‐0.3   p=NS     Mean glycated haemoglobin (%) (SD):   Baseline: 10.4 (2.5) vs 10.3 (2.3)   Post intervention: 10.3 (2.3) vs 10.6 (2.5)   Absolute difference: 0.3   Relative improvement: 3%   p=NS     *Baseline measures were assessed in 28 patients in the intervention group and 41 patients in the control group. Post intervention outcomes were assessed in respectively 85 and 81 patients.	No sign difference for patient outcomes between both groups at baseline   and at follow up     *Changes in diabetes treatment, the number of patients admitted to hospital for diabetes related reasons, mortality, diabetic retinopathy, referrals to hospital eye clinics were similar or identical in the two groups.   The number of patients with new cataract or cataract extraction during the study was significant larger in the intervention group (p<0.001)
Legorreta 1996	Educational materials +   educational meetings +   clinical multidisciplinary teams + skill mix changes   (nurse treating patients)   arrangements for follow up +   changes in medical records systems vs no intervention     The comparisons were made at two sites:   Site A: a typical participating medical group (PMG)   Site B: independent physician association	Not done	Glycated haemoglobin (%) (ref??)   Site A (N=116 vs 46):   Baseline: 8.8 vs 8.2   Post intervention: 7.2 vs 8.5   Absolute difference: 1.3   Relative improvement: 15%   DE‐DC=1.9     Site B (N=122 vs 19):   Baseline: 10.3 vs 9.0   Post intervention: 9.4 vs 8.8   Absolute difference: 0.6   Relative improvement: 7%   DE‐DC=0.7     In the control group there were much less patient that received a follow‐up measurement within 1 year. So also endpoints were compared defined as: the last reported value after a patient had participated in the program, or had been identified in the control site, for at least 12 months but for no longer than 28 months.     Site A (N=117 vs 88):   Baseline: 8.9 vs 8.3   Post intervention: 6.9 vs 9.1   Absolute difference: 2.2 Relative improvement: 24%   DE‐DC=‐2.7     Site B (N=123 vs 62):   Baseline: 10.3 vs 8.6   Post intervention: 9.0 vs 8.4   Absolute difference: 0.6   Relative improvement:   ‐7%   DE‐DC=1.1	No p‐value given because of a potential unit of analysis error     No differences between intervention and control group in baseline glycated haemoglobin levels were found at site A. In site B, however, a difference was found (p<0.05)     **Authors reported a significant difference in change between both groups after 1 year at site A, not at site B.   The difference in change from baseline to endpoints between both groups was significant at both site A (p=0.0001) and site B (p=0.0028).
Marrero 1995	Educational materials +   a telecommunication system + skill mix changes (nurse practitioners reviewed data on self‐monitoring of blood glucose and made insulin adjustments) + case management + changes in facilities and equipment   + changes in medical record systems vs no intervention	Not done	HbA1 (%) (ref: 6.5‐8.0%) (mean (SD)):   Baseline: 9.4 (1.9) vs 9.9 (1.5)   Post intervention: 10.0 (1.6) vs 10.3 (1.8)   Absolute difference: 0.3   Relative improvement: 3%   DE‐DC=‐0.2   p=0.544	No sign difference between both groups at baseline     Between groups no significant differences were found in hospitalisations or emergency room visits     There were no sign between‐ or within‐group differences for the self‐esteem, dependency, body image, depression or need for acceptation subscales of the OFFER‐questionnaire.     Over time, the control group showed a trend towards increased coping (p=0.06) and a decrease in mastery (p=0.06). Both groups exhibited an increase over time in importance of control (p=0.01)     *No sign between‐ or within‐group differences were found on the communication, roles, affective responsiveness, behaviour control, or general family functioning subscales of the Family Assessment Device. Over time, the experimental group had a decrease in problem solving scores, while the control group had an increase (P=0.01). Also, both groups had a small but significant decrease in affective involvement scores (P=0.03)     ****Diabetes‐specific quality of life showed no between‐ or within‐ group‐ group differences over the course of the study
Naji 1994	Educational materials + reminders + arrangements for follow up + changes in medical record systems vs no intervention, however, the patients in the control group also received reminders for routine appointments	Routine diabetic care visits (mean (SD)):   Post intervention: 5.3 (1.4) vs 4.8 (1.7)   Absolute difference: 0.5   Relative improvement: 10%   95% C.I. for difference:[0.1;0.9]     % with no record of assessment:   Post intervention: 0% vs 0%   Absolute difference: 0.0   Relative improvement: 0%     Glycated haemoglobin (mean (SD)):   Post intervention: 4.5 (1.4) vs 1.3 (1.0)   Absolute difference: 3.2   Relative improvement: 246%   95% C.I. for difference:[2.9;3.5]     % with no record of assessment:   Post intervention: 0% vs 22%   Absolute difference: 22%   Relative improvement: x%   95% C.I. for difference:[14;29]     Blood pressure (mean (SD)):   Post intervention 4.2 (1.4) vs 1.2 (1.0)   Absolute difference: 3.0   Relative improvement: 250%   95% C.I. for difference:[2.7;3.3]     % with no record of assessment:   Post intervention: 0% vs 21%   Absolute difference: 21%   Relative improvement: x%   95% C.I. for difference:[13;28]     Visual acuity (mean (SD)):   Post intervention: 2.6 (1.1) vs 0.7 (0.7)   Absolute difference: 1.9%   Relative improvement: 271%   95% C.I. for difference:[1.7;2.1]     % with no record of assessment:   post intervention: 2% vs 50%   Absolute difference: 48%   Relative improvement: 96%   95% C.I. for difference:[39;58]     Funduscopy (mean (SD)):   Post intervention: 1.1 (0.6) vs 0.9 (0.7)   Absolute difference: 0.2%   Relative improvement: 22%   95% C.I. for difference:[0.04;0.4]     % with no record of assessment:   Post intervention: 10% vs 30%   Absolute difference: 20%   Relative improvement: 67%   95% C.I. for difference:[10;30]     Peripheral pulses (mean (SD)):   Post intervention: 1.9 (1.1) vs 0.5 (0.6)   Absolute difference: 1.4%   Relative improvement: 280%   95% C.I. for difference:[1.2;1.6]   % with no record of assessment:   Post intervention: 7% vs 56%   Absolute difference: 49%   Relative improvement: 87%   95% C.I. for difference:[39;60]     Neurological examination (mean (SD)):   Post intervention: 1.9 (1.1) vs 0.5 (0.6)   Absolute difference: 1.4%   Relative improvement: 280%   95% C.I. for difference:[1.2;1.6]     % with no record of assessment:   Post intervention: 7% vs 59%   Absolute difference: 52%   Relative improvement: 88%   95% C.I. for difference:[41;62]     Feet (mean (SD)):   Post intervention: 1.4 (1.0) vs 0.5 (0.6)   Absolute difference: 0.9   Relative improvement: 180%   95% C.I. for difference:[0.7;1.1]     % with no record of assessment:   Post intervention: 22% vs 58%   Absolute difference: 36%   Relative improvement: 62%   95% C.I. for difference:[24;48]     % patients that had seen a dietician:   Post intervention: 26% vs 40%   Absolute difference: 14%   Relative improvement: ‐35%   95% C.I. for difference:[2; 26]     % patients that had seen a chiropodist:   Post intervention: 58% vs 26%   Absolute difference: 32%   Relative improvement: 123%   95% C.I. for difference:[20;44]	Glycated haemoglobin (%) (mean (SD)):   Baseline: 5.3 (1.4) vs 5.3 (1.4)   Post intervention: 5.3 (1.7) vs 5.3 (1.7)   Absolute difference: 0.0   Relative improvement: 0%   DE‐DC=0.0   95% C.I. for difference:[‐0.31; 0.037]1)     1)The comparison between both groups, for which baseline information was collected on a different scale from that collected at final review, was performed by analysis of covariance. The reported means have been adjusted at the mean level of the baseline scale     BMI (kg/m2 ) (mean (SD)):   Baseline: 27.6 (8.5) vs 28.3 (5.6)   Post intervention 28.7 (7.6) vs 27.9 (4.5)   Absolute difference: 0.8   Relative improvement:   ‐3%   DE‐DC=1.5   95% C.I. for difference:[‐2.4; 0.8]     Systolic blood pressure (mmHg) (mean (SD)):   Baseline: 155.9 (27.1) vs 153.9 (24.8)   Post intervention: 161.5 (25.1) vs 156.4 (25.7)   Absolute difference: 5.1   Relative improvement:   ‐3%   DE‐DC=‐3.1   95% C.I. for difference:[‐11.7; 1.5]     Diastolic blood pressure (mmHg) (mean (SD)):   Baseline: 85.6 (15.6) vs 84.8 (11.5)   Post intervention: 84.3 (11.1) vs 83.5 (9.9)   Absolute difference: 0.8   Relative improvement:   ‐1%   DE‐DC=0.0   95% C.I. for difference:[‐3.5; 1.9]     COSTS:   Urban practice (integrated care) vs coastal practice (integrated care) vs conventional care     Annual costs per patient:   £78.29 vs £101.22 vs £55.15 ****     Patient borne costs (integrated care vs conventional care)     Mean costs per visit:   £8 (95% CI £5.23 to £12.12) vs £1.70 (95% CI £1.16 to £2.47)	No sign difference between both groups at baseline     Separate analyses for Type 1 and Type 2 diabetes patients also found no differences between the intervention and control group     The diabetes health questionnaire only showed a significant difference between both groups for the item "support" for patients with non‐insulin dependent diabetes     **The discrepancy between the two practices with integrated care is partly explained by differences in their organisation of care
Nilasena 1995	Educational materials +   reminders + changes in medical records systems     vs no intervention	Compliance score:   Baseline: 38.0% vs 34.6%   Post intervention: 54.9% vs 51.0%   Absolute difference: 3.9%   Relative improvement: 8%   DE‐DC=0.5     *A significant change in compliance scores was found within both groups (p=0.0001). However, the difference in the change between both groups was not significant.	Not done
O'Connor 1995	Local consensus procedures + audit and feedback + skill mix changes   (nurses more actively assist in providing diabetes care) + more aggressive educational outreach to patients vs no intervention	Mean number of outpatient visits:   Baseline: 7.86 vs 7.40   Post intervention: 9.08 vs 8.96   Absolute difference: 0.12   Relative improvement: 1%   DE‐DC=‐0.34     At least 1 HbA1c‐test (N=134 vs 133):   Baseline: 78% vs 71%   Post intervention: 91% vs 91%   Absolute difference: 0%   Relative improvement: 0%   DE‐DC=‐7%	HbA1c (ref. 4.3‐6.1%) (SE) (N=99 vs 87):   Baseline: 8.4% (0.19) vs 8.9% (0.22) (p=0.06)   Post intervention: 7.9% (0.17) vs 8.8% (0.17)   Absolute difference: 0.9   Relative improvement: 10%   DE‐DC=‐0.4**	No p‐value given because of potential unit of analysis error     *Authors reported a significant difference between both groups (p=0.01) after analysis of covariance with adjustments for baseline measurements
Peters 1998	Educational materials + audit and feedback + revision of professional roles (nurses provided diabetes care based on protocols) + changes in medical records systems + arrangements for follow up vs no intervention	Intervention group vs control group:   Year 1: N=98 vs N=64   Year 2: N=74 vs N=55   Year 3: N=42 vs N=42     Compliance with ADA guidelines*:     HbA1c levels (%):   Year 1: 87% vs 24%   Year 2: 69% vs 14%   Year 3: 71% vs 11%   Absolute difference 1: 63%   Absolute difference 2: 55%   Absolute difference 3: 60%   Relative improvement 1: 263%   Relative improvement 2: 393%   Relative improvement 3: 545%     Lipid panels (%):   Year 1: 100% vs 36%   Year 2: 92% vs 39%   Year 3: 93% vs 49%   Absolute difference 1: 64%   Absolute difference 2: 53%   Absolute difference 3: 44%   Relative improvement 1: 178%   Relative improvement 2: 136%   Relative improvement 3: 90%     Foot exams (%):   Year 1: 100% vs 11%   Year 2: 96% vs 9%   Year 3: 93% vs 9%   Absolute difference 1: 89%   Absolute difference 2: 87%   Absolute difference 3: 84%   Relative improvement 1: 809%   Relative improvement 2: 967%   Relative improvement 3: 933%     Ophthalmology referrals (%):   Year 1: 99% vs 19%   Year 2: 92% vs 24%   Year 3: 95% vs 19%   Absolute difference 1: 80%   Absolute difference 2: 68%   Absolute difference 3: 76%   Relative improvement 1: 421%   Relative improvement 2: 283%   Relative improvement 3: 400%	HbA1c (%) (ref??‐6.8)   (Baseline: N=96 vs N=66   Year 1: N=95 vs N=56   Year 2: N=73 vs N=46   Year 3: N=47 vs N=28)     Baseline: 11.9 vs 10.0   Year 1: 8.8 vs 9.8   Year 2: 8.7 vs 10.1   Year 3: 8.6 vs 10.4   Absolute difference 1: 1.0   Absolute difference 2: 1.4   Absolute difference 3: 1.8   Relative improvement 1: 10%   Relative improvement 2: 14%   Relative improvement 3: 17%   (1) DE‐DC =2.9   (2) DE‐DC =3.3   (3) DE‐DC =3.7     Total median cholesterol concentrations in patients with an initial total cholesterol level>6.2 mmol/l (baseline values are compared with the mean value for all 3 years in each patient)   (N=29 vs N=13)     Baseline: 7.24 vs 7.54   Post intervention: 6.21 vs 7.45*   Absolute difference: 1.24   Relative improvement: 17%   DE‐DC =0.94	No statistical tests were undertaken for the process outcomes. The frequency of HbA1c testing met these standards if it was performed >=2 times/year in patients not taking insulin and >=4 times/year in patients taking insulin. Lipid panel frequency should be carried out at least yearly and foot exams should be carried out >=2 times/year     Differences at baseline between both groups in HbA1c p<0.005     A significant difference within the intervention group was reported over 3 years (p<0.001). In the control group no significant change was found     The profiles of repeated observations on individuals were compared using generalised estimating equations. The effects of subject‐specific variables (experimental group, recent onset or compliance) were tested for interaction with the time contrast.   Intervention versus control group:   Baseline(rank sum test): p<0.001   Year 1: p<0.09   Year 2 : p<0.05   Year 3 : p<0.01     ***Authors reported that serum creatinine levels and the presence or absence of proteinuria or microalbumiuria were not different at baseline or throughout the course of the study. Similarly, there were no differences in the baseline blood pressure levels or mean levels throughout the study. Furthermore total cholesterol levels in the total population did not differ between both groups. No values were given.
Rith‐Najarian 1998	Interrupted Time Series (ITS):     Educational materials + reminders + clinical multidisciplinary team vs pre intervention period	Not done	Average annual incidence of lower‐extremity amputation (LEA):   Any LEA (rate/1000 diabetic person years):   1990: 18   1991: 21   1992: 18   1993: 28   1994: 10   1995: 22   1996: 13     First LEA (rate/1000 diabetic person years):   1990: 3   1991: 14   1992: 16   1993: 16   1994: 3   1995: 7   1996: 7     Major LEA (defined as either a "below the knee amputation" or an "above the knee amputation"):   (rate/1000 diabetic person years):   1990: 3   1991: 8   1992: 13   1993: 8   1994: 10   1995: 11   1996: 4	Authors reported no significant differences calculated by chi‐square method.   p‐values comparing pre intervention period (90‐93) vs post intervention period:   Any LEA: 0.22   First LEA: 0.071   Major LEA: 0.85
Rutten 1990	Educational materials + case management vs no intervention	Not done	Intervention vs control group (N=55 vs N= 72)     Mean HbA1 (ref 5.3‐7.7%):   Baseline: 9.7% vs 8.9%**   Post intervention: 9.2% [8.8;9.6]) vs 9.4% [9.2‐9.7]   Absolute difference: 0.2   Relative improvement: 2%   DE‐DC =1.0     Mean individual change adjusted for diabetes regulation at the start of the study:   Adjusted change: ‐0.38 vs 0.46   (In the intervention a favourable effect in contrast to the control group)     Change in HbA1 in subgroups:   Subgroup 1: patients that proved to be able to carry out accurate self‐monitoring (N=33 at baseline)     Subgroup 2: patients that were unwilling or incapable of self‐monitoring (N=20 at baseline)     Subgroup 3: patients who had up to then been under specialist care (N=13 at baseline)     Subgroup 4: patients in control group who remained under conventional GP care     Subgroup 5: patients in control group who remained under specialist care     Subgroup 1: ‐0.47 (SD±1.57 ; CI [‐1.0;0.07])   Subgroup 2: ‐0.28 (SD±1.29 ; CI [‐0.35;0.91])   Subgroup 3: ‐0.60 (SD±1.76; CI [‐1.9;0.7])   Subgroup 4: +0.41 (SD±1.03 ; CI [0.14;0.68])   Subgroup 5: +0.98 (SD±1.39 ; CI [0.32;1.64])     Body weight (kg):   Baseline: 73.3 (SD±15.3) vs 76.7 (SD±13.0)   Post intervention: 72.9 (SD±14.9) vs 76.8 (SD±12.7)   Absolute difference: 3.9   Relative improvement: 5%   DE‐DC =0.5     Mean individual change adjusted for diabetes regulation at the start of the study:   Adjusted change: ‐0.3 vs   ‐0.1	No p‐values are given because of potential unit of analysis error     Significant differences in HbA1 were found at baseline p<0.05     **Authors reported a significant difference in mean individual change in HbA1 between both groups (p<0.01) after adjusting for the diabetes regulation at the start of the study. This significant difference was not found for body weight.
See Tai 1999	Reminders + changes of medical record system (implementation of new diabetes templates) vs usual diabetes care (usual basic template), but implementation of new asthma templates	Use of diabetes templates:     Number of patients on whom the template was used at least once (mean percentage per practice):   Baseline: 21% vs 1%   Post intervention: 43% vs 4%   Absolute difference: 39%   Relative improvement: 975%   DE‐DC= 19%	Not done	No results of statistical analyses were reported by the authors
Shultz 1992	A telecommunication system + changes in facilities and equipment + changes in medical record systems vs no intervention	Not done	Glycohaemoglobin (mg/dl):   Baseline:   Group 1: 7.2± 1.8 mmol/l   Group 2: 7.5± 1.8 mmol/l     The data were combined for all patients using the device and graphs and compared with all patients using the diaries. For the group using the intervention the blood glycohaemoglobin dropped significantly (p<0.003) whereas no change overall was found in the group using diaries. Post intervention values are not reported	No sign difference between both groups at baseline     *The study design is a cross‐over trial. Group 1 began with the communication device to report glucose data for the first 6 months and then used a paper diary for the next 9 months. Group 2 used a paper diary for the first 6 months and followed with the communication device for the following 9 months
Stein 1974	Distribution of educational materials + revision of professional roles (a nurse practitioner trained in the management of diabetes mellitus) + patient education vs usual care	Not done	Blood sugar (mg/ml)   Baseline: 121 (range 62‐198) vs 172 (range 90‐300)   Post intervention: 140 (range 90‐275) vs 130 (range 90‐226)   Absolute difference: ‐10   Relative improvement:   ‐8%   DE‐DC= ‐61     Weight (LB):   Baseline: 188 (range 136‐271) vs 208 (range 150‐306)   Post intervention: 192 (range 138‐268) vs 212 (range 149‐304)   Absolute difference: 20   Relative improvement:   9%   DE‐DC= 0	The comparison patients were slightly more obese with higher blood sugar levels     *Changes within each group and between the study and the comparison group were not statistically significant (no p‐values are stated)
Taplin 1998	Educational material + local consensus processes + audit and feedback + reminders +   marketing (establishing a team and after that, regular team meetings to discuss and achieve clinical goals) +   clinical multidisciplinary team   + changes in medical record systems vs no intervention	Group 1: study population (part of Group Health Cooperative) (N=59)   Group 2: total population of Group Health Cooperative (393,628)   Group 3: surrounding practices (8294)     % compliance with guideline for diabetic eye care:   Baseline: 64% vs 53% vs 45%   Post intervention: 72% vs 60% vs 56%   Absolute difference 1: 12%   Absolute difference 2: 16%   Relative improvement 1: 20%   Relative improvement 2: 29%   (1)DE‐DC =1%   (2)DE‐DC =‐3%	Not done	Not clear whether there is a significant difference between both groups at baseline     No p‐values are given because of potential unit of analysis error     **Eye care compliance was high in the study population at baseline and improved with time, but not significantly, probably because of insufficient power to detect the difference. Eye care did improve in the surrounding practices (p=0.034) and in GHC as a whole (p<0.0001), but this improvement was in part due to their low initial levels of compliance
Vinicor 1987	For patient outcomes four different groups were compared:   Group 1: no intervention   Group 2: patient education   Group 3: physician education consisting of:   educational materials + educational meetings + local consensus processes + audit and feedback + reminders +   communication and case discussion between distant health professionals +   Group 4: patient education + physician education   (publication of Vinicor 1987)     For process outcomes:   Group 3 and group 4 were combined as also group 1 and group 2 were combined ‐>     Educational materials + educational meeting + local consensus processes + audit and feedback + reminders +   Communication and case discussion between distant health professionals +   vs no intervention   (publication of Mazzuca 1988)	% of total clinic visits for monitoring metabolic control:     Fasting blood glucose:   Post intervention: 40% vs 31%   Absolute difference: 9%   Relative improvement: 29%     Random blood glucose:   Post intervention: 65% vs 74%   Absolute difference: 9%   Relative improvement: ‐12%     Urine test record:   Post intervention: 58% vs 52%   Absolute difference: 6%   Relative improvement: 12%1)     History of hypoglycaemia:   Post intervention: 78% vs 77%   Absolute difference: 1%   Relative improvement: 1%1)     1) denominator reflect only those visits in which a prescription for insulin or oral hypoglycaemic agents was in force     % of patients for whom dietary management recommendations were followed:     Diet prescription   Post intervention: 80% vs 62%   Absolute difference: 18%   Relative improvement: 29%     % of patients for whom recommendations for monitoring chronic complications were followed on at least an annual basis     Visual symptoms:   Post intervention: 82% vs 78%   Absolute difference: 4%   Relative improvement: 5%     Visual acuity:   Post intervention: 38% vs 30%   Absolute difference: 8%   Relative improvement: 27%     Fundus examination:   Post intervention: 38% vs 34%   Absolute difference: 4%   Relative improvement: 12%     BUN or creatinine   Post intervention: 79% vs 72%   Absolute difference: 7%   Relative improvement: 10%     Foot examination:   Post intervention: 92% vs 87%   Absolute difference: 5%   Relative improvement: 6%     Discuss foot care:   Post intervention: 68% vs 64%   Absolute difference: 4%   Relative improvement: 6%     Neurologic examination:   Post intervention: 6% vs 6%   Absolute difference: 0%   Relative improvement: 0%     History of peripheral pain:   Post intervention: 33% vs 43%   Absolute difference: ‐10%   Relative improvement: 23%     History of urinary symptoms:   Post intervention: 68% vs 64%   Absolute difference: 4%   Relative improvement: 6%     Postural hypotension:   Post intervention: 7% vs 7%   Absolute difference: 0%   Relative improvement: 0%     Impotence (males only)   Post intervention: 10% vs 10%   Absolute difference: 0%   Relative improvement: 0%     Blood pressure (q visit):   Post intervention: 89% vs 88%   Absolute difference: 1%   Relative improvement: 1%     Baseline electrocardiography:   Post intervention: 85 vs 78%   Absolute difference: 7%   Relative improvement: 9%     Smoking history   Post intervention: 56% vs 49%   Absolute difference: 7%   Relative improvement: 14%     Cholesterol or triglycerides (q 2 years:   Post intervention: 70% vs 58%   Absolute difference: 12%   Relative improvement: 21%     Carotid and femoral bruits:   Post intervention: 8% vs 9%   Absolute difference: 1%   Relative improvement: 11%	Group 2 vs Group 3 vs Group 4 vs Group 1 (control group)     Fasting plasma glucose (mg/dl) (Mean ± SD)   (N=61 vs 58 vs 54 vs 65):   Baseline: 11.9±4.8 vs 11.6±4.6 vs 12.7±6.0 vs 11.2±5.1   Post intervention: 11.0±4.4 vs 10.9±5.0 vs 10.6±4.5 vs 11.6±6.4   Absolute difference (2‐1): 0.6   Absolute difference (3‐1): 0.7   Absolute difference (4‐1): 1.0   Relative improvement   (2‐1): 5%   Relative improvement   (3‐1): 6%   Relative improvement   (4‐1): 9%   (2‐1)DE‐DC =1.3   (3‐1)DE‐DC =1.1   (4‐1)DE‐DC =1.6     A1Hgb (%)(Mean ± SD):   (N=64 vs 60 vs 56 vs 67):   Baseline: 10.17±2.53 vs 10.51±2.84 vs 11.34±3.16 vs 10.19±3.32   Post intervention: 10.23±2.53 vs 10.64±2.52 vs 10.42±2.94 vs 10.74±3.14   Absolute difference (2‐1): 0.51   Absolute difference (3‐1): 0.10   Absolute difference (4‐1): 0.32   Relative improvement   (2‐1): 5%   Relative improvement   (3‐1): 1%   Relative improvement   (4‐1): 3%   (2‐1)DE‐DC =0.61   (3‐1)DE‐DC =0.68   (4‐1)DE‐DC =1.47     2 Hour postprandial (mg/dl):   (N=58 vs 55 vs 52 vs 63):   Baseline: 18.0±6.0 vs 18.1±5.9 vs 20.6±6.3 vs 17.2±6.6   Post intervention: 17.2±5.8 vs 17.2±6.0 vs 17.0±5.7 vs 17.8±7.6   Absolute difference (2‐1): 0.6   Absolute difference (3‐1): 0.6   Absolute difference (4‐1): 0.8   Relative improvement   (2‐1): 3%   Relative improvement   (3‐1): 3%   Relative improvement   (4‐1): 4%   (2‐1)DE‐DC =1.4   (3‐1)DE‐DC =1.5   (4‐1)DE‐DC =4.2     Weight (LBS):   (N=66 vs 61 vs 53 vs 65):   Baseline: 186.6±39.8 vs 188.8±42.2 vs 193.8±43.1 vs 185.3±44.8   Post intervention (adjusted for baseline): 184.7 vs 184.9 vs 183.9 vs 189.3   Absolute difference (2‐1): 4.6   Absolute difference (3‐1): 4.4   Absolute difference (4‐1): 5.4   Relative improvement   (2‐1): 2.4%   Relative improvement   (3‐1): 2.3%   Relative improvement   (4‐1): 2.9%   (2‐1)DE‐DC =4.7   (3‐1)DE‐DC =4.5   (4‐1)DE‐DC =5.8     Systolic blood pressure*   (N=69 vs 62 vs 58 vs 67):   Baseline: 139.9±16.0 vs 142.5±21.1 vs 140.4±16.5 vs 137.2±17.5   Post intervention: 138.9 vs 145.0 vs 144.7 vs 146.3   Absolute difference (2‐1): 7.4   Absolute difference (3‐1): 1.3   Absolute difference (4‐1): 1.6   Relative improvement   (2‐1): 5%   Relative improvement   (3‐1): 1%   Relative improvement   (4‐1): 1%   (2‐1)DE‐DC =8.7   (3‐1)DE‐DC =3.8   (4‐1)DE‐DC =3.1     Diastolic blood pressure**:   (N=69 vs 62 vs 58 vs 67):   Baseline: 84.7±9.5 vs 83.1±9.9 vs 81.8±9.6 vs   81.4±9.2   Post intervention: 81.9 vs 83.4 vs 81.5 vs 85.5   Absolute difference (2‐1): 3.6   Absolute difference (3‐1): 2.1   Absolute difference (4‐1): 4.0   Relative improvement   (2‐1): 4%   Relative improvement   (3‐1): 3%   Relative improvement   (4‐1): 5%   (2‐1)DE‐DC =6.1   (3‐1)DE‐DC =4.1   (4‐1)DE‐DC =4.3	No significant differences between both groups at baseline in process measures. These values are not reported. Furthermore also for patient outcomes no significant differences were found at baseline with the exception of post‐prandial plasma glucose.     No p‐values are given because of potential unit of analysis error     Authors reported significant differences between the intervention and control group for the process outcomes: fasting blood glucose (p=0.004), random blood glucose (p=0.002), diet prescription (p<0.001), cholesterol or triglycerides (p=0.016)   For patient outcomes significant differences were found between group 2 and group 1 for fasting plasma glucose (p<0.05), glycated haemoglobin (p<0.05), body weight (p<0.05), systolic‐ (p<0.05) and diastolic blood pressure (p<0.01). Between group 3 and group 1 significant differences were found for fasting plasma glucose (p=0.05), glycosylated haemoglobin (p<0.05), weight (p=0.05).   Between group 4 and group 1 significant differences were found for fasting plasma glucose (p<0.01), glycosylated haemoglobin (p<0.01), weight (p<0.01) and diastolic blood pressure (p<0.005).     **Possible ceiling effect:   The lower baseline glycosylated haemoglobin levels of patients who were reassessed, especially in group 1 and group 3 could have made it more difficult to detect significant effects of the interventions
Weinberger 1995	Patient mediated interventions   (nurses attempted to telephone patients to facilitate compliance, monitor patients' health status, facilitate resolution of identified problems, facilitate access to primary care) + arrangements for follow up + patient education vs no intervention	Not done	Glycohaemoglobin (%) (ref 4.7‐7.2%) (mean±SE):   Baseline: 10.7±3.3 vs 10.7±3.4   Post intervention: 10.5±0.2 vs 11.1±0.3   Absolute difference: 0.6   Relative improvement: 5%   DE‐DC =0.6   P=0.046*     Fasting blood glucose (mmol/l) (mean±SE):   Baseline: 10.3±3.7 vs 10.2±4.2   Post intervention: 9.7±0.2 vs 10.7±0.4   Absolute difference: 1.0   Relative improvement: 9%   DE‐DC =1.1   P=0.011*     Analyses of subgroups     1) Hyperlipidemic patients (total cholesterol ³200mg/dl)   (N=97(interv)+34(contr)):     Seen by dietician (%):   Post intervention: 31% vs 6%   Absolute difference: 25%   Relative improvement: 417%   P=0.003     % taking lipid‐lowering medications:   Post intervention: 22% vs 9%   Absolute difference: 13%   Relative improvement: 144%   P=0.096     Total cholesterol (mmol/l) (mean±SD):   Absolute change:   ‐0.30±0.86 vs ‐0.11±0.85   Relative improvement: 173%   P=0.270     Triglycerides (mmol/l)   (mean±SD):   Absolute change:   ‐0.50±5.40 vs   ‐1.15±6.47   Relative improvement:   ‐57%   P=0.572     LDL cholesterol (mmol/l):   (mean±SD):   Absolute change:   ‐0.21±0.63 vs 0.008±0.73   Relative improvement: NA   P=0.161     HDL (mg/dl) (mean±SD):   Absolute change:   ‐0.07±0.28 vs 0.005±0.19   P=0.378     Obese patients (weight at study enrolment>=120% of ideal body weight)   (N=115(interv)+41(contr))     Change in weight (kg)   (mean±SD):   Absolute change:   ‐0.9±5.3 vs ‐0.1±3.6   Relative improvement:   P=0.202     Seen by dietician (%):   Post intervention: 30% vs 7%   Absolute difference: 23%   Relative improvement: 329%   P=0.003	No significant differences between both groups at baseline     *Authors reported no significant difference in health‐related quality of life (SF‐36) change scores between the intervention and control groups

Methods	RCT (nonequivalent control group design, randomised by clinic area)   Randomisation concealment: DONE   Follow up:   ‐ providers: DONE   ‐ patients: N/A   Blinded assessment: DONE Baseline: NOT CLEAR   Reliable outcomes: DONE   Protection against contamination: DONE no unit of analysis error
Participants	A general medicine clinic, Indianapolis (US).   99 internal medicine residents and 15 faculty internists, 98 were included (Type 2 diabetes).   providers ‐ 98   patients ‐ 2791   encounters ‐ 8132   practices ‐ 1 clinic
Interventions	Intervention group: Professional intervention (distribution of educational materials + educational meetings, reminders + audit and feedback) + patient education Control group: only received a postgraduate seminar Length of intervention:   11 months
Outcomes	PROCESS:   GHb   Fasting blood sugar   Home‐monitored blood glucose   Diet   Oral hypoglycaemic agents PATIENT:   NONE
Notes	National guidelines (ADA‐guidelines)   ‐directed at monitoring and treatment   ‐targets: adherence to five key program recommendations (see process outcomes)
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate

Methods	RCT (pragmatic randomised trial, randomised by patient)   Randomisation concealment: NOT CLEAR   Follow up:   ‐ providers: N/A   ‐ patients: DONE   Blinded assessment: DONE for glycated haemoglobin, Creatinine, Diabetes Health, process measures   NOT CLEAR for blood pressure , BMI   Baseline: DONE for glycated haemoglobin, Creatinine, BMI, blood pressure   NOT CLEAR for Diabetes Health, process measures   Reliable outcomes: DONE for glycated haemoglobin, Creatinine, Diabetes Health   NOT CLEAR for blood pressure , BMI, process measures   Protection against contamination: DONE
Participants	A hospital clinic and general practice groups in Grampian (UK).   Adult patients attending   the clinic for at least one year and registered with any of the three general practices (Type 2 diabetes)   providers ‐ ?   (GPs + clinic staff involved in diabetes care)   patients ‐ 274   practices ‐ 1 clinic +   3 general practices
Interventions	Intervention group:   Professional intervention (distribution of educational materials + reminders) + organisational intervention (arrangements for follow‐up + changes in medical record systems) Control group:   Received reminders for routine appointments at the clinic (arrangements for follow‐up) Length of intervention:   2 years
Outcomes	PROCESS:   Routine diabetic care visits   Glycated haemoglobin   Blood pressure   Creatinine   Visual acuity   Funduscopy   Peripheral pulses Neurological examination   Feet   % patients that had seen a dietician   % patients that had seen a chiropodist PATIENT:   Glycated haemoglobin   BMI   Creatinine   Systolic blood pressure   Diastolic blood pressure Diabetes health questionnaire COSTS:   Annual costs per patient
Notes	Not clear if the guidelines that the practices received were national or local developed   ‐directed at montoring and treatment   ‐targets: metabolic control and frequency of measurement and examination during routine visits
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Methods	RCT (incomplete block design, randomised by provider)   Randomisation concealment: NOT CLEAR   Follow up:   ‐ providers: NOT CLEAR   ‐ patients: N/A   Blinded assessment: NOT CLEAR   Baseline: DONE   Reliable outcomes: NOT CLEAR   Protection against contamination: NOT CLEAR no unit of analysis error
Participants	Outpatient clinics at the University of Utah and Salt Lake Veterans Affairs Hospital (US).   Internal medicine residents.   Patients who had been treated at one of the two sites within one year prior to the study (Type 1 and Type 2 diabetes).   providers ‐ 35 of 36   patients ‐ 164   practices ‐ 2 clinics
Interventions	Intervention group:   Professional intervention (distribution of educational materials + reminders) + organisational intervention (changes in medical records systems) Control group: usual care Length of intervention:   6 months
Outcomes	PROCESS:   Compliance score PATIENT:   NONE
Notes	National guidelines (selection of ADA‐guidelines was used)   ‐directed at monitoring   ‐targets:glycaemic control and renal‐, foot‐, eye‐, macrovascular‐, and neurologic care
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Methods	RCT (block design, randomised by practice)   Randomisation concealment: NOT CLEAR   Follow up:   ‐ providers: NOT CLEAR   ‐ patients: NOT CLEAR   Blinded assessment: DONE   Baseline: NOT CLEAR except NOT DONE for Glyc‐Hb   Reliable outcomes: NOT CLEAR   Protection against contamination: DONE unit of analysis error
Participants	General practices in South Glamorgan (UK), that had been committed for at least two years to an annual peer review clinical audit of diabetic care. 29 of 33 eligible practices participated.   All practices were asked to recruit 12 patients who met the inclusion criteria (type 2 diabetes)   providers ‐ ?   patients ‐ 190 (165 completed follow‐up)   practices ‐ 29
Interventions	Intervention group: Professional intervention (educational meetings + educational outreach visits (continuing support by research nurse for providing patient centred care)) Control group: usual care Length of intervention:   18 months
Outcomes	PROCESS:   Attendance at practice over last 12 months PATIENT:   Glyc‐Hb   BMI   Weight   Systolic blood pressure   Diastolic blood pressure   Measure of complications   Mean satisfaction score   Health status (SF‐36)
Notes	Guidelines not specified in the paper
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Methods	ITS   Intervention independent of other changes: DONE   Sufficient data points to enable reliable statistical inference: NOT DONE   Formal test of trend: N/A Intervention unlikely to affect data collection: DONE   Blinded assessment: DONE   Completeness of data set: DONE   Reliable outcomes: NOT CLEAR
Participants	Rural primary care clinic in northern Minnesota (US).   A foot‐care team was formed consisting of a family physician, two clinic nurses, a home care nurse, a nutritionist and a registrar.   Patients were American Indians identified through surveillance having diabetes. They were entered into a diabetes registry and followed thereafter (not clear which type of diabetes).   Provider ‐ 1 physician   + 3 nurses   (+nutritionist+registrar)   patients ‐ 449   practices ‐ 1
Interventions	Intervention group: Professional intervention (distribution of educational materials + reminders) + organisational intervention (clinical multidisciplinary team) Control group: N/A Length of intervention:   3 years
Outcomes	PROCESS:   NONE PATIENT:   Lower‐extremity amputation (LEA)   First LEA   Major LEA (defined as either a "below the knee amputation" or an "above the knee amputation")
Notes	Local guidelines   ‐directed at diagnosis, treatment, monitoring and risk factor assessment   ‐targets: to reduce lower‐extremity amputations
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	D ‐ Not used

Methods	RCT (incomplete block cross‐over design, randomised by patient)   Randomisation concealment: NOT CLEAR   Follow up:   ‐ providers: N/A   ‐ patients: NOT DONE   Blinded assessment: DONE   Baseline: DONE   Reliable outcomes: DONE   Protection against contamination: NOT DONE
Participants	Veterans Administration Hospital (US)   Patients using insulin were selected by virtue of having the highest blood glycohaemoglobins on record during the preceding 18 months (not clear which type of diabetes).   providers ‐ ?   (physicians)   patients ‐ 30 (20   completed follow‐up)   practices ‐ 1 hospital
Interventions	Intervention group:   Professional interventions (patient mediated intervention   (a telecommunication system was used to assist in outpatient management) + organisational intervention (changes in physical structure, facilities and equipment (modem + glucometer‐M) + changes in medical record systems) Control group: usual care Length of intervention:   9 months   Follow up: 15 months
Outcomes	PROCESS:   NONE PATIENT:   Glycohemoglobin
Notes	Guidelines not specified in the paper
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Methods	RCT (block design with a block size of two, randomised by patient)   Randomisation concealment: DONE   Follow up:   ‐ providers: N/A   ‐ patients: DONE   Blinded assessment: DONE   Baseline: NOT CLEAR   Reliable outcomes: DONE   Protection against contamination: NOT CLEAR
Participants	The outpatient facility of Wishard Memorial Hospital in Indianapolis (US)   General medicine patients who had insulin or oral hypoglycemic agents prescribed or continued during the index visit and who had visited the clinic in the previous year and had a scheduled appointment to return to the clinic (Type 1 and Type 2 diabetes).   providers ‐ ?   patients ‐ 859   practices ‐ 1 general   medicine clinic
Interventions	Intervention group:   Organisational intervention (arrangements for follow up) + patient education Length of intervention:   Average 12 months. Data were standardised for duration of follow up
Outcomes	PROCESS:   Kept scheduled visits   Prescription refills   Walk‐in visits   Total contacts   Visit failures   Total scheduled visits (kept and failed)   Hospitalisations PATIENT:   Hospitalisations
Notes	Guidelines not specified in the paper
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate

Methods	RCT (2x2 balanced design randomised by practice)   Randomisation concealment: NOT CLEAR   Follow up:   ‐ providers: NOT CLEAR   ‐ patients: NOT DONE   Blinded assessment: DONE   Baseline: NOT CLEAR   Reliable outcomes: DONE   Protection against contamination: DONE no unit of analysis error
Participants	General practitioner tutors from two medical schools who practised locally in North London (UK) and used an EMIS (Egton medical Information Services) computer system.   Patients who gave consent for access to records (not clear which type of diabetes).   providers ‐ 17 general   practitioners and 11   practice nurses   patients ‐ 167   practices ‐ 6
Interventions	Intervention group:   Professional intervention (reminders) + organisational intervention (changes in medical record systems (use of computer templates)) Control group: using new computer templates for asthma Length of intervention:   1 year
Outcomes	PROCESS:   Use of diabetes templates PATIENT:   NONE
Notes	National guidelines (developed by the British Diabetes Association)   ‐directed at monitoring   ‐targets: glycaemic control,   lipid profile, serum creatinine, current medication
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Methods	RCT (blocked randomisation scheme in a 3:1 ratio, to increase the power to detect also differences across 3 study nurses (intervention strategy). Randomisation by patient)   Randomisation concealment: NOT CLEAR   Follow up:   ‐ providers: N/A   ‐ patients: DONE   Blinded assessment: DONE   Baseline: DONE   Reliable outcomes: DONE   Protection against contamination: NOT CLEAR
Participants	Veterans Affairs general medical clinic (US).   Patients that were currently using an oral hypoglycemic agent or insulin and received primary care from the General Medical Clinic (GMC) and had at least one GMC visit during the previous year and had a pending GMC appointment and kept a scheduled GMC appointment during a six‐month enrolment period in 1991 (Type 2 diabetes).   providers ‐ ?   patients ‐ 275   practices ‐ 1 general   medical clinic
Interventions	Intervention group Professional intervention (patient mediated interventions   (nurses attempted to telephone patients to facilitate compliance, monitor patients' health status, facilitate resolution of identified problems, facilitate access to primary care)) + organisational intervention (arrangements for follow‐up) + patient education by telephone Control group: usual care Length of intervention:   1 year
Outcomes	PROCESS:   NONE PATIENT:   Glycohemoglobin   Fasting blood glucose   Health‐related quality of life:   Physical functioning   Social functioning   Physical role functioning   Emotional role functioning   Mental health   Vitality   Bodily pain   General health perceptions In the subgroup of hyperlipidemic patients (total cholesterol >=200mg/dl):   Seen by dietician   % taking lipid‐lowering medications   Total cholesterol   Triglycerides   LDL cholesterol   HDL cholesterol In the subgroup of obese patients (weight at study enrolment>=120% of ideal body weight):   Change in weight   Seen by dietician
Notes	Guidelines not specified in the paper
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Study	Reason for exclusion
Albisser 1996	Patient orientated intervention
Domurat 1999	Quasi‐experimental design ‐ poor chioce of control site (the intervention focused only on a high‐risk subpopulation, this was compared with all diabetes patients receiving usual care)
Harrower 1995	Quasi‐experimental design (No contemporous data collection‐> no parallel groups)
Ronnemaa 1997	Patient orientated intervention
Rosenqvist 1988	Quasi‐experimental design ‐ poor choice of control site (intervention group ‐ general practices who received an educational intervention to change practice and implemented the recommended changes, control site practices ‐ received the educational intervention but did not implement the recommended changes)
Williams 1990	Quasi‐experimental design ‐ controlled before ‐after study but no baseline measurement in the control group

PERMALINK

Interventions to improve the management of diabetes mellitus in primary care, outpatient and community settings

Carry Mira Renders

Gerlof D Valk

Simon J Griffin

Edward Wagner

Jacques ThM van Eijk

Willem JJ Assendelft

Abstract

Background

Objectives

Search methods

Selection criteria

Data collection and analysis

Main results

Authors' conclusions

Plain language summary

Background

Description of the condition

Description of the intervention

How the intervention might work

Why it is important to do this review

Objectives

Methods

Criteria for considering studies for this review

Types of studies

Types of participants

Types of interventions

Types of outcome measures

1) Health professional performance, including (process outcomes):

2) Patient outcomes, including:

3) Self report measures with known validity and reliability, including:

Search methods for identification of studies

Electronic searches

Data collection and analysis

Data analysis:

1. Table of summarised results for professional interventions vs usual care.

2. Table of summarised results for organisational interventions vs usual care.

3. Table of summarised results for professional+organisational interv vs usual care.

Results

Description of studies

Targeted behaviours

Type of diabetes

Characteristics of providers

Characteristics of interventions (see EDITORIAL INFORMATION under GROUP DETAILS for METHODS USED IN REVIEWS)

Barriers to change

Strength of evidence for the desired change in practice

Risk of bias in included studies

RCTs

CBA

ITS

Effects of interventions

Comparisons: professional intervention versus usual care

4. Professional interventions vs usual care.

Conclusion:

Comparisons: organisational intervention versus usual care

5. Organisational interventions vs usual care.

Conclusion:

Comparisons: professional in combination with organisational interventions versus usual care

6. Professional ‐ in combination with organisational interventions vs usual care.

Conclusion:

Discussion

Types of interventions

Professional and organisational interventions

Patient‐oriented intervention

Revision of professional roles

Telecommunication systems

Financial interventions

Types of populations

Methodological considerations

Unit of analysis error

Effect sizes

Generalisability

Study size and loss‐to‐follow‐up

Hawthorne‐effect

Inclusion of Interrupted Time Series (ITS) and Controlled Before After studies (CBA)

Duration of follow‐up

Micro‐ and macrovascular complications

Authors' conclusions

Implications for practice.