eTabelle 3. Studies with improved adherence to medications and improved clinical outcomes in the intervention group.
Article | Study type recruit ment | Population number, age, male, NYHA (I/II/III/IV), comorbidities | Comparison Intervention (IG) vs. control (CG) | Risk of bias (I/II/III/IV /V/VI) | Patient adherence (measurement, followup) IG vs. CG | Conclusions on primary outcome, clinical outcomes and adherence |
---|---|---|---|---|---|---|
Antonicelli 2010 (e7) |
RCT Italy 16 months |
57 hospitalized HF patients 78±7 years, 61% male NYHA: 0/58/37/5% Exclusion of patients with severe dementia, debilitating psychiatric disorders or chronic renal failure requiring dialysis |
IG (n=28):
|
unclear/ unclear/ high/ low/ low/ low |
Adherence to prescribed treatment: 12-months: 89.7 vs. 35.7% | Intervention can improve the composite endpoint of mortality and hospitalization and medication adherence (RD 0.47; 95%CI 0.25 to 0.70), but not mortality and quality of life. |
Brotons 2009 (e9) |
RCT Spain 01/2004 to 09/2005 |
283 hospitalized HF patients 76±8 years, 45% male NYHA 49/45/5/1% Diabetes: 42% Hypertension: 76% Exclusion of patients with a cognitive deficit |
IG (n=144):
|
low/ low/ high/ low/ low/ low |
Adherence to pharmacological treatment (high scores are better) 12-months: 86.1 vs. 75.5%. |
Intervention can reduce mortality and hospital readmissions, improve QoL and medication adherence (RD 0.11; 95%CI 0.01 to 0.21). |
Galbreath
2004 (e11) |
RCT USA 1999 to 2003 |
1069 patients with HF
symptoms identified
through lists from
partner institutions 71±10 years, 71% male NYHA: 19/57/21/3% Diabetes: 28% Hypertension: 72% Hyperlipidemia: 50% |
IG (n=710):
|
unclear/ unclear/ unclear/ unclear/ low/ low |
Adherence to guideline-based medications in systolic HF patients 18-months: 54.4 vs. 43.3% |
Intervention can decrease mortality, but not event-free survival and improve longtime medication adherence (RD 0.11; 95%CI 0.03 to 0.19). - |
GESICA 2005 (e12) |
RCT Argentin a 06/2000 to 11/2001 |
1518 ambulatory stable HF patients 65±13 years, 71% male NYHA III-IV: 49% Diabetes: 21% Hypertension:59% Exclusion of patients with primary pulmonary hypertension |
IG (n=760):
|
low/ low/ unclear/ low/ high/ low |
Adherence to medication and diet (mean follow-up of 16 months): beta-blocker: 59 vs. 52% spironolactone: 27 vs. 23% digoxin: 33 vs. 29% furosemide: 77 vs. 70% ACE-inhibitors: 78 vs.6% Drug stop: 8 vs. 18%. dietary transgressions: 20 vs. 65% |
Intervention can decrease mortality, readmissions and the probability of worsening HF and improve QoL and medication adherence (no drug stops of any drugs: RD 0.10; 95%CI 0.07 to 0.14 and diet: RD 0.45; 95%CI 0.40 to 0.49). |
Sadik 2005 (e6) |
RCT United Arab Emirate s |
221 HF patients from general medical wards and from cardiology and medical outpatient clinics 59 years, 50% male NYHA: 30/50/16/4% Diabetes: 18% Hypertension: 23% Exclusion of patients with low cognitive status |
IG (n=109):
|
low/ unclear/ high/ low/ low/ low |
Compliance with the
prescribed medicines:
12-months: 82 vs. 34% Lifestyle advice: baseline: 21 vs. 22% 12-months: 72 vs. 28% |
Intervention can improve QoL and compliance to medications (RD 0.48; 95%CI 0.36 to 0.60) and lifestyle adjustments (RD 0.44; 95%CI 0.32 to 0.56) with no influence on mortality. |
Wu 2012 (e5) |
RCT USA |
82 HF ambulatory and
hospitalized patients 60±13 years, 57% male NYHA I-II/III-IV: 51/49% Charlson comorbidity index: 3.1±1.9 Exclusion of patients with impaired cognition |
IG (n=54):
|
unclear/
unclear/ low/ unclear/ low/ high |
Medication taking adherence: baseline: 70 vs. 59 vs. 64% 9-months: 74 vs. 65 vs. 36% |
Intervention improved eventfree survival, hospitalization, but not mortality and QoL. Intervention can improve adherence in both intervention groups (RD 0.38; 95%CI 0.14 to 0.63 and RD 0.29; 95%CI 0.03 to 0.54). |
CG, Control group; CI, confidence interval; DM, disease management; HF, heart failure; IG, intervention group; n, number of randomized participants; NYHA, New York
Heart Association; QoL, Quality of life; RD, risk difference; RCT, randomized control trial;
RD>0 describe better adherence in IG
Risk of bias: I, random sequence generation; II, allocation concealment, III, blinding of outcome assessment; IV, incomplete outcome data; V: selective reporting; VI: otherbias