Sjöblom P, Anders T, Löfgren UB, et al. Can diabetes medication be reduced in elderly patients?: An observational study of diabetes drug withdrawal in nursing home patients with tight glycaemic control. Diabetes Research & Clinical Practice 2008;82:197-202.
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/18823673
| Methods | Study design: Prospective cohort study
Number of groups: Two groups |
| Participants | Number of participants: 98 enrolled
· Active deprescribing group: 32 enrolled · Control group: 66 enrolled Age: 84.4 ± 6.8 years Sex: 57 female, 41 male Participants with dementia: No Inclusion criteria: · Type 2 diabetes · Resident at participating aged care facilities · HbA1C < 5.9% mmol/L Exclusion criteria: · Type 1 diabetes · Dietary treatment only · Bad condition · HbA1C > 6.0 mmol/liter Diabetes Follow-up duration: 10.6 ± 8.9 years Concomitant medicines: Most frequently used drugs were categorized within three groups; · Psychiatric medication used for alleviating depression or dysthymia, anxiety or sleeping disorders (antidepressants, neuroleptics benzodiazepines) · Cardiovascular associated medication (diuretics, low-dose aspirin, beta-blockers,and ACE-inhibitors) · Third prominent group of medication were analgesics, mostly paracetamol but even morphine were common Country: Sweden Setting: Residential aged care facilities – 17 different nursing homes with a total of 658 residents in the counties of Ostergotland and Jonkoping, Sweden |
| Interventions | Medicine: Oral hypoglycemic medicines and insulin
Withdrawal schedule: Abrupt except insulin over 20 units/day for which the dose was halved Comparator: Residents with diabetes that meet one of the exclusion criteria (i.e. HbA1C > 6.0%, type 1 diabetes, dietary treatment, or bad condition) |
| Outcomes | Glycaemic control
HbA1C Clinical outcomes All cause mortality |
| Dates | Dates: 2006
Follow-up duration: Six months |
| Funding sources | Medical Research Council of Southeast Sweden, the Research Board of NSO¨ and the R&D Department of Local Health Care, County Council of Ostergotland |
| Notes | Authors stated: “Conflict of interest: No conflict of interest was declared |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | High risk | Not randomized.
Allocation to group was based on type of diabetes, HbA1c < 6 and diabetic medication. |
| Allocation concealment (selection bias) | High risk | Not concealed. |
| Blinding of participants and personnel (performance bias) | 5 out of 5 | The study appears to have been open. |
| Blinding of outcome assessment (detection bias) | 5 out of 5 | The study appears to have been open. |
| Incomplete outcome data (attrition bias) | 1 out of 5 | It is intention-to-treat analysis and the data all appears to be present.
All drop-outs accounted for. |
| Selective reporting (reporting bias) | 1 out of 5 | There was a pre-specified protocol as the study had ethical approval. It is unclear if the authors adhered to a pre-specified analysis plan as the study’s protocol was not published. However, the stated objectives are reported. |
| Confounding (non-randomized) | 5 out of 5 | The intervention and control groups were not comparable. The control group consists of the residents at participating aged care facilities diagnosed with diabetes but did not satisfy the study’s inclusion/exclusion criteria. |
| Other bias | Low risk | |
| Newcastle-Ottawa scale | ||
| Selection bias | Representativeness of the exposed cohort | Selected group of volunteers. |
| Selection of the non-exposed cohort | Concurrent control group drawn from a different source. | |
| Ascertainment of exposure | Ascertainment of exposure was by secure record. | |
| Demonstration that outcome of interest was not present at start of study | Demonstrated that outcome of interest was not present at start of study. | |
| Comparability bias | Comparability of cohorts on the basis of the design or analysis | Study controlled for diabetes medication, baseline blood sugar, and diabetes type (type 1/type 2), and poor prognosis. |
| Outcome bias | Assessment of outcome | Assessment of outcome by record linkage. |
| Was follow-up long enough for outcomes to occur | Follow-up likely long enough for outcomes to occur. | |
| Adequacy of follow-up of cohorts | Subjects lost to follow-up unlikely to introduce bias – small number lost (16%). | |
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