| Literature DB >> 25118842 |
K Ayling1, S Brierley, B Johnson, S Heller, C Eiser.
Abstract
OBJECTIVE: Poor descriptions of standard care may compromise interpretation of results in randomised controlled trials (RCTs) of health interventions. We investigated quality of standard care in RCTs of behaviour change interventions for young people with type 1 diabetes and consider implications for evaluating trial outcomes.Entities:
Keywords: control group; meta-analysis; reporting; standard care quality; type 1 diabetes
Mesh:
Year: 2014 PMID: 25118842 PMCID: PMC4270262 DOI: 10.1080/08870446.2014.953528
Source DB: PubMed Journal: Psychol Health ISSN: 0887-0446
Figure 1. Flow of information through review process.
Standard care activities assessed and relevant behaviour change techniques.
| Standard care activity | Behaviour change technique (Michie et al., |
|---|---|
| General information (verbal or written) about diabetes management | Provide information on how to perform the behaviour |
| Information about the consequences of sub-optimal control | Provide information on consequences of the behaviour to the individual |
| Provide contact details for relevant support groups | Plan social support/social change |
| Feedback on most recent HbA1c /A1c | Provide feedback on performance |
| Encouragement of regular monitoring of blood glucose levels | Prompt self-monitoring of behaviour outcome |
| Discuss common barriers and ways to overcome them | Prompt barrier identification/ problem-solving |
| Involve family members in diabetes self-care | Plan social support/social change |
| Set personal goals for diabetes management (behaviour) | Goal setting (behaviour) |
| Set personal targets for optimal HbA1c or Equivalent (outcome) | Goal setting (outcome) |
| Identify individual problems relating to diabetes management and generate solutions | Prompt barrier identification/ problem-solving |
| Use of alarms, cues or reminders to complete diabetes tasks | Teach to use prompts/cues |
| Help plan for holidays, special events and sick days | Relapse Prevention/ Coping Planning |
| Liaison with relevant others (e.g. schools and employers) about diabetes | Plan social support/social change |
| Provide annual review | Provide feedback on performance |
| Adherence to a dietary plan (e.g. carb counting) | Action Planning |
| More frequent contact for those with poor control or most difficulties | Additional: Service Provision |
| Contact with a Dietitian | Additional: Service Provision |
| Contact with a psychologist | Additional: Service Provision |
| Access to 24 h telephone or online support for acute problems | Additional: Service Provision |
Published details of standard care.
| Trial | Frequency of contact | Details of care environment | Specified health professionals involved in care | Additional details |
|---|---|---|---|---|
| Charron-Prochownik, Ferons-Hannan, Sereika, and Becker ( | No Details Provided | Diabetes clinic | No Details Provided | None |
| Cook, Herold, Edidin, and Briars ( | Every 3 months | 2 Children’s Hospitals | No Details Provided | None |
| Couper, Taylor, Fotheringham, and Sawyer ( | Every 3 months | Women’s and children’s Diabetes Clinic | Paediatric endocrinologist | 24 hour phone support |
| Dietitian | ||||
| Diabetes Educator | ||||
| de Wit et al. ( | Every 3 months | 4 Paediatric Diabetes Clinics | 6 Paediatricians | None |
| Ellis et al. ( | Every 3 months | Children’s Hospital | Endocrinologist | Required to test blood sugar 3–4 times per day |
| Endocrinology Clinic | Nurse | Prescribed diet | ||
| Tertiary Care | Dietician | Access to mental health services | ||
| Social Worker | ||||
| Psychologist | ||||
| Ellis et al. ( | Every 3 months | Children’s Hospital | Endocrinologist | Access to mental health services |
| Endocrinology Clinic | Nurse | |||
| Tertiary care | Dietician | |||
| Social Worker | ||||
| Psychologist | ||||
| Franklin, Waller, Pagliari, and Greene ( | Every 3–4 months | No Details Provided | Multidisciplinary Team (Psychologist specified) | Access to emergency hotline |
| Gay et al. ( | Every 3 months | Hospital Outpatient Clinic | Diabetologist | Contact with patient increased by Diabetologist if deemed necessary |
| 5 Paediatric Endocrinologists | ||||
| Graue, Wentzel-Larsen, Hanestad, and Søvik ( | Every 3 months | Hospital Paediatric Outpatient Department | Physician | 30 Minute appointments |
| Diabetes Nurse Specialist | Access to Dietitian | |||
| Access to Social worker | ||||
| Access to Clinical Psychologist Discussions of insulin delivery and other issues affecting care | ||||
| Grey, Boland, Davidson, Li, and Tamborlane ( | Monthly | Children’s Diabetes Clinic | Physician | Required to test blood sugar ≥ 4 times daily |
| Nurse Practitioners/Certified Diabetes Educators | Between visit telephone contact | |||
| Dietician | ||||
| Social Worker | ||||
| Hains, Davies, Parton, Totka, and Amoroso-Camarata ( | Every 3–4 months | Children’s Hospital | No Details Provided | None |
| Diabetes Clinic | ||||
| Laffel et al. ( | Every 3–4 months | Paediatric and Adolescent Unit | Multidisciplinary Care (no details specified) | Follow-up visits |
| Diabetes Centre | Contact between visits | |||
| Encouragement around routine diabetes management | ||||
| Received educational materials | ||||
| Lawson, Cohen, Richardson, Orrbine, and Pham ( | Every 3 months | Children’s Hospital | Diabetologist | Recommended to test blood sugar ≥ 3 times daily (breakfast, supper and bedtime) with lunchtime tests on weekends and weekdays if possible |
| Diabetes Clinic | Diabetes Nurse Specialist | Between visit contact with Diabetologist or Nurse to adjust insulin as required | ||
| Tertiary care | Diabetes Dietitian | Target preprandial blood sugars of 4–8 mmol/L | ||
| Adherence to diabetes meal plan based on carbohydrate counting or food exchanges | ||||
| Contact with patient increased by Diabetologist if deemed necessary | ||||
| HbA1c tested at each visit | ||||
| Lehmkuhl et al. ( | No Details Provided | Paediatric Endocrinology Clinic | No Details Provided | None |
| Mulvaney, Rothman, Wallston, Lybarger and Dietrich ( | No Details Provided | Paediatric Diabetes Clinic | No Details Provided | None |
| Murphy et al. ( | Every 3 months | 10 Paediatric Diabetes Clinics | No Details Provided | None |
| Olmsted, Daneman, Rydall, Lawson, and Rodin ( | Every 3 months | Children’s Hospital | Multidisciplinary Care (no details specified) | Target preprandial blood sugars of 4–10 mmol/L |
| Tertiary care | Adherence to meal plan based on food exchanges or on carbohydrate counting | |||
| Panagiotopoulos, Preston, Stewart, Metzger and Chanoine ( | Every 6 months | Children’s Hospital | No Details Provided | Encouraged to regularly test Blood Glucose |
| Diabetes Clinic | Emergency phone contact | |||
| Viklund, Örtqvist, and Wikblad ( | No Details Provided | Outpatient Clinic | No Details Provided | None |
| Wysocki et al. ( | Every 3–4 Months | No Details Provided | Paediatric Endocrinologist | Examination by a physician |
| Physician | GHb tested ≥ 3 times annually; | |||
| Home blood glucose monitoring and recording of test results | ||||
| Diabetes education provided | ||||
| Emphasis on active self-management | ||||
| Prescribed diet | ||||
| Regular physical exercise | ||||
| Annual review for diabetic complications |
Figure 2. Variability in standard care quality.
Figure 3. Forest plot of standardised effects on glycaemic control.
Figure 4. Bubble plot of standardised effects on glycaemic control against standard care quality.
Figure 5. Forest plot of standardised effects on psychological outcomes.
Figure 6. Bubble plot of standardised effects on psychological outcomes against standard care quality.