Table 2. Summary of Review Articles.
Period and Methods | Inclusion and Exclusion Criteria N = Number of Studies |
Intervention | Impact, Process, and Outcomes Assessed |
Notes/Comments Re: QOL in Minority and Disadvantaged Populations |
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Eakin EG, Bull SS, Glasgow RE, Mason M. Reaching those most in need: a review of diabetes self-management interventions in disadvantaged populations. Diabetes Metab Res Rev. 2002;18:26-35. | ||||
1987-2001: MEDLINE supplemented by review of bibliographies from identified studies and reviews |
Included English-language RCTs or quasi- experimental studies with comparison group; DSME intervention delivered to an underserved/ disadvantaged group or community. |
Component DSME, group and individual sessions, informational mailings, media campaign, peer support, home visits, unstructured sessions, videotapes, handouts, monthly calls from nurse |
RE-AIM (Reach, Efficacy, Adoption, Implementation, and Maintenance) framework used to compare and evaluate studies Physiological GHb, cholesterol, BP, weight, FBG, BMI, body composition, glucose tolerance and symptoms |
Studies were conducted with explicit focus on minority and disadvantaged populations. |
A summary methodologic rating of 0 to 9 was calculated. Scores ranged from 2 to 8, with 4 studies receiving a score of 7 or more. |
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Excluded descriptive reports and studies without comparison group. N = 10 studies |
Content DM knowledge, early detection, exercise, nutrition, lifestyles, history and culture (Pima Indian community), compliance, access to primary care Setting Delivered in community centers, community, hospital clinic, and by telephone |
Behavioral Diet, physical activity, smoking, EtOH use Knowledge DM self-management (nutrition, general DM), changes in medication regime Other Cost to provide intervention Psychosocial Depression, social support, self-efficacy, and QOL QOL: 3 of 10 studies |
Authors emphasize that DSME interventions for underserved populations should explicitly address social-contextual issues. |
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Authors suggest that interventions designed to be proactive, such as telephone follow-up and behaviorally focused DSME interventions incorporated within the primary care visits, have successful levels of implementation. |
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QOL instruments: Daniel et al, 1999-not reported; Glasgow et al, 1992-assessed diabetes- specific QOL with a modified DCCT DQOL scale, no between-group statistical significance observed; Weinberger et al, 1995-measured HRQOL using the SF-36; statistical significance not observed. |
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Ellis SE, Speroff T, Dittus RS, Brown A, Pichert JW, Elasy TA. Diabetes patient education: a meta-analysis and meta-regression. Patient Educ Couns. 2004;52:97-105. | ||||
1990-12/2000: MEDLINE, CINAHL, HealthSTAR, ERIC, Science Citation Index, PsyclNFO, CRISP, and AADE database |
Included English-language RCTs using educational, including nonpharmacological, intervention intended to improve patients’ health status (physical, intellectual, and/or psychosocial), interventions for adults, and reporting pre- and postintervention A1C values (at least 12 weeks postintervention). N = 28 studies |
Elasy’s taxonomy used to categorize educational interventions and assess relationship between specific variables within the interventions and metabolic control. |
Physiological A1C Psychosocial HRQOL/QOL: not reported |
Authors report only A1C measures, noting other important outcomes were neither uniformly available nor uniformly measured in the literature. |
Component Didactic, negotiated goal setting; goal setting; situational problem solving; cognitive reframing; and other unspecified |
Authors used meta-regression to identify “components” of the educational intervention that best explained variance in metabolic control. Meta-analysis supports the notion that patient education improves glycemic control. |
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Content Diet, exercise, self- monitoring blood glucose, basic diabetes knowledge, medication adherence, psychosocial, and other unspecified |
The authors examined the impact of the number of “episodes” as well as the duration, and neither of these dose-related indicators predicted (was an indicator) an intervention’s success or failure. |
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Setting No reported setting. Referred solely to the number of recipients |
Authors note that work would have been enhanced with the inclusion of behavioral outcomes. |
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Gary TL, Genkinger JM, Guallar E, Peyrot M, Brancati FL. Meta-analysis of randomized educational and behavioral interventions in type 2 diabetes. Diabetes Educ. 2003;29:488-501. | ||||
1966-1999: MEDLINE; Cochrane Collaboration database (1990-1999); references from experts, colleagues, previous meta-analyses, and review articles |
Included published trials randomized by clinician and/or patient, sample size ≥ 10, English language; educational, counseling, or behavioral interventions aimed at long-term self-care behavior. |
Components Individual and group counseling, instruction packets and audiovisual materials, telephone outreach; clinician prompting, clinician education, computer programs |
Physiological FBG, total glycohemoglobin, hemoglobin A1 or hemoglobin A1C, body weight or BMI, blood pressure, and lipids Psychosocial QOL: not reported |
Authors assigned and categorized methodologic quality scores. Scores were grouped into low (<0.65), moderate (0.65- 0.79), and high (≥ 0.80), with 5 studies receiving a quality rating of high. |
Excluded published abstracts, type 1, drug interventions, and studies evaluating short-term effects. N = 18 studies |
Content Patient-diet, exercise, medication regime changes or adherence, BGSM, and foot care |
Authors found that compared with controls, most intervention groups produced a decline in glycohemoglobin. Furthermore, group and individual counseling produced similar effects. |
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Providers-methods to increase patient involvement, DM pathophysiology, complications, DM education, urine testing, and treatment/regimen adherence Setting Outpatient clinic (96%) |
Authors note that very few studies reported including African American or Hispanic individuals. |
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Authors cite few studies that have evaluated culturally sensitive interventions for African Americans and other ethnic minority populations, an issue that should be addressed. |
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Authors note lack of QOL measurement as a limitation. |
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Glazier RH, Bajcar J, Kennie NR, Willson K. A systematic review of interventions to improve diabetes care in socially disadvantaged populations. Diabetes Care. 2006;29: 1675-1688. | ||||
1986-2004: MEDLINE, EMBASE, CINAHL, Health STAR, Cochrane Library, Sociological Abstracts, Social Science Citation Index, and International Pharmaceutical Abstracts |
Included RCT, CT, and before-and-after studies with a control group; studies aimed toward low SES or ethnic/racial minority or socially disadvantaged adults with type 1 and 2 DM. Included studies of any language that measured self-management, provider management, or clinical outcomes. |
Elasy’s intervention taxonomy used to describe scope and components of the interventions. |
Physiologic FBG.A1C, BP, BMI, lipids, mortality, DM complications Patient behavior Glucose monitoring, diet and exercise, medication adherence and self- adjustment, scheduling and/or attending scheduled medical appointments Provider behavior Management: diagnostic testing, prescribing, referrals, educational and behavioral counseling Psychosocial QOL: not reported |
Studies focused on those groups with low SES or belonging to an ethno- racial minority. To evaluate methodological quality, the authors used an evaluation method to identify specific intervention features that are associated with successful or unsuccessful outcomes: (1) target of intervention, (2) intervention design, (3) setting, (4) delivery, and (5) intensity and duration. |
Components Individualized assessment and goal setting, individual educational counseling, DSME, reminder cards, videotapes, support groups, case management, evidenced-based guidelines, community health workers/peer educators, group visits, treatment algorithms | ||||
Excluded: age-specific, gestational DM studies; studies that only reported hospital process of care measures; and those not specifying which socially disadvantaged group. N = 11 studies |
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Content DM knowledge, self-care, symptoms and treatment, exercise, nutrition, foot care, lifestyle, monitoring; clinician-focused evaluation and management of glycemic control, associated comorbidities and complications |
Authors suggest that cultural tailoring, use of community educators or lay educators, one-on-one interventions, individualized assessment/reassessment, use of treatment algorithms, behavioral interventions, and patient feedback are all consistent with positive rate differences found in multiple studies. |
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Setting Primary care practice sites, hospitals, community- based clinics, community facilities (centers, churches), and telephone |
High-intensity (>10 contacts) and delivery over a long time frame (≥ 6 months) were also associated with success intervention in disadvantaged groups. |
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Loveman E, Royle P, Waugh N. Specialist nurses in diabetes mellitus. Cochrane Database Syst Rev. 2003;(2):CD003286. | ||||
1966-11/2002: MEDLINE, Cochrane library, EMBASE, CINAHL, British Nursing Index, Royal College of Nursing Index, HealthSTAR, BIOSIS, PsyclNFO, Science Citation Index, Social Sciences Citation Index; hand-searched relevant journals and conference proceedings (1990-2001), reference lists, National Research register, Early Warning system and Current Controlled Trials registries |
Included randomized controlled and controlled clinical trials designed to test effects of DNS/NCM interventions, trial duration 6 months. |
Components DNS plus routine care versus routine care, automated calls with structured messages, treatment regime alterations led by DNS/NCM, treatment recommendations to PCP by DNS/NCM, and care coordination within primary care system Content Goal setting and self-care Setting Hospital, outpatient clinic, primary care system, and community |
Physiological All trials used A1C as endpoint; short-term complications (hypoglycemic episodes, hyperglycemic incidents) |
Methodologic quality of studies was assessed using factors included in Schulz and Jadad’s quality criteria: minimization of selection, attrition, and detection bias. Studies were then subdivided in the following categories: low, moderate, and high risk of bias. |
Excluded studies with no control group, group education, no prespecified outcomes, other team members other than DNS/NCM involved delivering intervention, nurses not able to adjust treatments. N = 6 studies |
Other Emergency room visits, hospitalizations Psychosocial Quality of life QOL: 1 of 6 studies with no data presented |
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Other Prespecified outcomes established for this review but not included and/or reported in trials: long-term complications (retinopathy, neuropathy, and nephropathy), mortality, BMI, costs, and adverse effects |
Authors noted that the quality of trials was mostly not good, making it difficult to assess the implications for practice. Future research suggestions include international observational studies to identify roles and time allocations; qualitative studies and RCTs of specialist nurse intervention. |
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Norris SL, Engelgau MM, Venkat Narayan KM. Effectiveness of self-management training in type 2 diabetes: a systematic review of randomized controlled trials. Diabetes Care. 2001;24:561-587. | ||||
1/1980-12/1999: MEDLINE, ERIC, CINAHL, restricted to RCTs, hand-searched several relevant journals; abstracts and dissertations were excluded |
Included English-language RCTs examining the effectiveness of self- management training, all or most subjects with type 2 DM, age >18, multicomponent interventions included (if educational component evaluated separately). Excluded children. N = 72 studies |
Components Chart reminders, group and individual sessions, written information, videos, didactic education, individual sessions based on patient’s priorities, home visits, computer knowledge assessment program, feedback, behavior modification, contracts, demonstrations, food logs, nutrition goals, interactive computer, culturally appropriate flashcards, pharmacist, nursing students, dietitian , lay health worker, nurse-led sessions, psychologist-led group sessions, patient-led education, and self-study course |
Physiological Weight, lipids, blood pressure, glycemic control Behavioral Dietary, physical activity, self-care skills Knowledge Diabetes Other Economic measures; health care utilization Psychosocial Attitudes, problem solving, anxiety levels, quality of life QOL: yes, in 5 studies Kaplan 1987-increase in QOL at 18 months for lifestyle intervention (intensive counseling on diet + physical activity). Gilden 1992-increase in QOL at 2 years follow-up for coping skills intervention (6 weekly sessions +18 monthly support group sessions). |
Authors qualitatively summarized outcomes to generate hypotheses, categorize variables for quantitative syntheses, and illustrate the vast heterogeneity of methods and outcomes in the included literature. |
Notably, the authors emphasize limited literature measuring QOL and long-term clinical outcomes. Authors advocate for a more holistic view of patients, including that QOL outcomes take precedence in future research and more diverse study populations. |
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Content | Three studies (deWeerdt, Glasgow, Trento) considered “brief interventions” with no significant difference between intervention and control groups. |
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Physical activity, diet, nutrition, SMBG, weight loss, barriers, social support, foot care, general DM knowledge, self-adjustment of insulin, goal setting, problem solving, stress management, patient empowerment, self- control, self-management |
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Setting Not specifically identified in the review; described as heterogeneous |
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Norris SL, Lau J, Smith SJ, Schmid CH, Engelgau MM. Self-management education for adults with type 2 diabetes: a meta-analysis of the effect on glycemic control. Diabetes Care. 2002;25:1159-1171. | ||||
1980-1999: MEDLINE, ERIC, CINAHL; manual search of relevant journals, and experts were consulted for citations |
Included English-language RCTs, DSME interventions, and other interventions when delivered in combination with DSME (if effect of DSME could be examined separately). |
Components Didactic or collaborative DSME, individual and group education, support groups, home visits, dietician, flashcards by lay health workers, meal demonstration, feedback, telephone follow-up, psychologist-led group sessions, weight loss program, empowerment techniques, computer- assisted knowledge assessment and instruction |
Physiological GHb, HbA1, HbA1c Psychosocial QOL: not identified as a key outcome of this review |
Meta-regression indicates no significant interactions except total contact. In 15 studies, GHb measurements were reduced for every hour of additional contact, which approximates 23.6 hours of contact between an educator and patient to achieve a 1% reduction; brief intervention appears to be less effective. |
Excluded abstracts and dissertations. N = 31 studies |
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Content Diet, physical activity, SMBG or urine glucose, foot care, coping, self-efficacy, identifying and preventing complications, goal setting, and modeling Setting Clinic, home, and senior center |
Authors suggest that psychosocial mediators, cultural relevancy, and health care system structure and primary care linkage may account for the heterogeneity in outcomes. |
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Authors stress that further research to identify predicators and correlates needs to focus on psychosocial attributes, social support, and problem-solving skills. |
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Norris SL, Nichols PJ, Caspersen CJ, et al. The effectiveness of disease and case management for people with diabetes: a systematic review. Am J Prev Med. 2002; 22(suppl 4):15-38. | ||||
1966-12/2000: MEDLINE, ERIC, CINAHL, HealthSTAR, Chronic Disease Prevention database (health promotion and education subfile), Combined Health Information Database, diabetes, health promotion and education subfile), journals hand- searched, reference list of included articles and consultation with team experts for relevant citations |
Included published comparative study designs, English language, conducted in established market economies as defined by the World Bank, studies with primary investigation of disease (as defined by review team) and case management intervention, reported information on 1 or more outcomes of interest preselected by review team. |
Components Disease or case management along with DSME, telemedicine support, insulin adjustment algorithms, group support, visit reminders, hospital discharge assessment and follow-up Content Not applicable or not specified Setting Managed care organizations and community clinics |
Physiological A1C, weight, BMI, BP, and lipids Behavioral SMBG, patient health care utilization; provider screening, monitoring and treatment): A1C, lipids, dilated eye exams, foot exams, proteinuria Other Health care system: health insurance, provision of services, health care utilization (admissions, outpatient visits, length of stay), public health services, economic outcomes Psychosocial Self-efficacy, patient satisfaction, quality of life |
Authors note research gaps in the areas of intervention effectiveness on long-term health and QOL outcomes, as well as diverse populations and settings. |
QOL Instrument: Peters et al (1998) used the SF-36 with 2 (unspecified) diabetes- specific questions added. | ||||
Excluded: studies characterized as limited quality based on the number of threats to validity, dissertations, and abstracts. N = 42 studies |
QOL: Assessed in 2 of 42 studies (1 in adults and 1 in children); adult cohort study reported relative change of +4.7% between groups. |
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Renders CM, Valk GD, Griffin SJ, Wagner EH, Eijk Van JT, Assendelft WJ. Interventions to improve the management of diabetes in primary care, outpatient, and community settings: a systematic review. Diabetes Care. 2001;24:1821-1833. | ||||
1966-2000: MEDLINE, EMBASE, CINAHL, EPOC, and Cochrane clinical trial registries (1999); reference list of selected articles was reviewed |
Included studies of effectiveness of interventions to improve process of care or patient outcomes among type 1 or type 2 that had (1) randomized or quasi- experimental trials, (2) interrupted time series with defined interventions and a minimum of 3 before-and-after time points, (3) nonrandomized studies with a second controlled site, and (4) predetermined measures of patient outcomes or the process of health care. |
Components Professional (education, reminders, audit, and feedback); organizational (role revision, changes in medical record systems; patient education, learner-centered counseling, telephone follow-up for missed appointments); financial (fee for services and grants) or multistrategy Content Provider-guidelines Patient-problem solving and decision making Setting Primary care, outpatient, and community |
Physiological Glycemic control, BP, cholesterol, BMI, weight, microvascular and/or macrovascular complications, albumin, creatinine Behavioral Patient attendance, provider process measures: glycemic control, BP, weight, microvascular complications, cholesterol, visits, education, health survey, compliance care providers, albumin, urine protein, creatinine, hospitalizations |
The authors note that complex professional interventions improved the process of care, but patient outcomes were rarely assessed, making it less clear to evaluate the impact. Furthermore, the authors emphasize that measuring both process and patient outcomes lead to better understanding of how to improve quality of care. |
Excluded study interventions classified as only patient oriented. N = 41 studies |
Other Hospitalizations, health care system process measures: glycemic control, BP, weight, cholesterol, visits, education, microvascular complications Psychosocial Well-being, quality of life QOL: yes, but limited 3 of 41 (2 QOL and 1 well-being) studies. QOL outcomes showed no effect in 2 professional and organizational interventions; well-being reported as positive effect in 1 education intervention. |
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Sarkisian CA, Brown AF, Norris KC, Wintz RL, Mangione CM. A systematic review of diabetes self-care interventions for older, African American, or Latino adults. Diabetes Educ. 2003;29:467-479. | ||||
01/1995-12/2000: MEDLINE, HealthSTAR, EMBASE, PsyclNFO, Ageline, and Sociological abstracts |
Included English-language published intervention studies that described intervention aimed at changing knowledge, beliefs or behavior; targeted 1 or more of the following: age >55 years, African American or Latino adults with DM; and measure at least 1 of the preidentified outcomes: glycemic control, diabete- srelated symptoms, or quality of life. N = 12 studies |
Components Group education plus exercise class; group sessions led by physician, nurse, or dietitian; didactic DM education alone or in combination with support groups, individual counseling, 1-to-1 DM education, bicultural community health worker liaison, nutritionist, weekly pharmacist appointments, grocery store tour, follow-up phone calls, physician education |
Physiological Glycemic control and diabetes-related symptoms (established as an outcome of interest by review authors but not assessed in any of the 12 included studies) Psychosocial Quality of life HRQOL/QOL In 5 of 12 studies: 4 of 8 RCTs and 1 of 4 pre/post designs; 1 RCT reported statistically significant improved QOL in the intervention arm (78 points vs 71 points); |
Authors were unable to summarize the effect of self-care interventions on quality of life because of the heterogeneity of QOL instruments. |
The authors suggest that age- and culture-specific interventions be designed for clinical trials. | ||||
Content Exercise, nutrition, goal setting, “standard DM education curriculum,” others unspecified/unclear Setting Noted as urban or rural |
1 pre/post design reported improved mean scores on the QOL instrument, with no mean change in A1C at end of intervention. |
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Steed L, Cooke D, Newman S. A systematic review of psychosocial outcomes following education, self-management and psychological interventions in diabetes mellitus. Patient Educ Couns. 2003;51:5-15. | ||||
1980-2001: EMBASE, MEDLINE, Psyclit; hand search of reference list of reviews and retrieved papers |
Included pre/post or controlled trial design studies published in English-language peer- reviewed journals, adults with type 1 or 2 DM, provision of DMSE or psychological intervention and assessed either QOL or psychological well- being. |
Components Classified as education, self- management, or psychological biofeedback. Content General education, diet, meal planning, goal setting, reinforcement, modeling, reward systems, problem solving, exercise sessions, behavior change maintenance, relaxation, communication skills, and social support Professional or layperson- led discussion groups Setting Not reported |
Psychosocial Overall psychological well- being, depression, anxiety, or emotional adjustment and QOL HRQOUQOL Ten studies used a generic measure, 9 used a diabetes-specific measure, 1 used both, and 5 studies used an overall psychological well-being measure. |
This review did not speak to issues related to minority or disadvantaged groups. The authors were unable to examine the efficacy of different intervention components; noted as the original aim of the review, multiple components in single studies and the overlap between components in different intervention categories hindered these attempts. Self-management interventions had beneficial impact on QOL. None of the included studies using psychological |
Excluded interventions that provided only diet or exercise or intensive insulin regimens. N = 36 studies |
Generic QOL measures: 2 of 9 studies showed improvement relative to control; DM-specific QOL measures: 6 of 9 found improvement. Overall psychological well- being: 1 of 5 reported significant improvemen. Global and disease-specific QOL were not assessed in any of the psychological interventions. |
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Authors suggest that future research should use diabetes-specific studies measures within larger controlled trials. |
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QOL Instrument: SF-36 and DQOL were the most frequently used generic and diabetes-specific instruments, respectively. |
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van Dam HA, van der Horst F, van den Borne B, Ryckman R, Crebolder H. Provider-patient interaction in diabetes care: Effects on patient self-care and outcomes: a systematic review. Patient Educ Couns. 2003;51:17-28. | ||||
1980-10/2001: MEDLINE Advanced, EMBASE, PsycIit/PsycINFO, and The Cochrane Library |
Included English-language RCTs and quasi- experimental studies testing the effects of modification of patient- provider interaction and provider consulting style on DM self-care and outcomes. |
Component Provider training, questionnaire prompts, feedback reports; patient- automated telephone calls, nurse telephone feedback, individual education, empowerment group ed. sessions, group consultations with doctor, and individual consultation with standard DM education |
Physiological BP, lipids, BMI, GlyHb, general health, mortality Behavioral Health behavior Knowledge DM knowledge Psychosocial Satisfaction, well-being, mental health, self- efficacy, DM-specific QOL scores |
Methodological quality was assessed using a modified version of the Van Tulder criteria list; the authors include a table of the criteria. Nineteen items (questions) are categorized into the following categories: patient selection, interventions, outcome measurements, and statistics. The mean quality score was 17.3 out of 19 total points. |
Excluded non-type 2 DM patients, case, case control, and nonexperimental studies. N = 8 studies |
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Content Provider-behavioral change, communications, patient- centered consulting, guidelines; patient-diet, self-care, problem solving/barriers, decision making Setting General practice or hospital outpatient |
Patient: communication, interaction, lifestyle, perception of care, functional, attitudes Provider: beliefs, attitudes, and behavior change; adherence to guidelines, time spent with patient |
Authors emphasize a shift from the traditional medical model and toward a patient empowerment model with shared decision making. |
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HRQOUQOL In 2 of 8 studies: 1 with no change in HRQOL scores and 1 with “better” QOL. |
Authors note they found no evidence that the 3 most promising studies have ever been replicated among diverse patient populations or different care settings, thus causing alarm. |
RCT, randomized controlled trial; DSME, diabetes self-management education; DM, diabetes mellitus; BP, blood pressure; FBG, fasting blood glucose; BMI, body mass index; QOL, quality of life; HRQOL, health-related quality of life; DQOL, diabetes quality of life; DCCT, Diabetes Control and Complications Trial Research Group; SES, socioeconomic status; PCP, primary care provider; CT, controlled trial; BGSM, blood glucose self-monitoring; DNS/NCM, diabetes nurse specialist/nurse case manager; SMBG, self-monitoring of blood glucose.