TABLE 5.
Methodological details of the various analyses
| Ref | Time framea | Operational definitions of (in)dependent variables or random variables | Timing BAASIS measurements |
|---|---|---|---|
| Validation analysis of the relationship of the BAASIS to other variables (part 1: other adherence measures): EM | |||
| Dobbels27 | Concurrent | EM assessment of same prior month as covered by the BAASIS recall period, expressed in parameters of taking adherence (% prescribed doses taken), timing adherence (% of expected intakes with an interdose interval deviating <25% from prescribed) and omissions of >1 consecutive doses. Parameters were calculated from the raw data. | Baseline,b 3 (randomization), 6,c and 9c mo |
| Lieb8 | Concurrent | EM assessment of same prior 2 wks as covered by the BAASIS recall period, expressed in parameters of taking adherence (% prescribed doses taken) and timing adherence (% of intakes within 2-h time window around the intake time). Data were delivered as parameter calculations from the authors. | Baseline, 2, 4, 6, 10, and 12 wk. Note: The recall period was changed to 2 wk. |
| Low33 | Concurrent | EM assessment of same prior month as covered by the BAASIS recall period, expressed in parameters of taking adherence (% prescribed doses taken), timing adherence (% of expected intakes with an interdose interval deviating <25% from prescribed) and omissions of >1 consecutive doses. Parameters were calculated from the raw data. | Baseline (randomization),b 3,c 6,c 9,c and 12c mo |
| Schäfer11 | Prospective | 3 mo of EM assessment following BAASIS measurement, expressed in parameters of taking adherence (% prescribed doses taken), timing adherence (% of expected intakes with an interdose interval deviating <25% from prescribed), and omissions of >1 consecutive doses. Parameters were calculated from the raw data. | At inclusion |
| Validation analysis of the relationship of the BAASIS to other variables (part 1: other adherence measures): self-report instruments | |||
| Ducci28 | Concurrent | Immunosuppressant Therapy Adherence Scale | At inclusion |
| Low33 | Concurrent | Morisky Medication Adherence Scale | At inclusion and four 3 monthly visitsc |
| Marsicano9,34 | Concurrent | Measure of adherence to treatment | At inclusion |
| Schmid37 | Concurrent | Immunosuppressant Therapy Adherence Scale | At inclusion |
| Validation analysis of the relationship of the BAASIS to other variables (part 1: other adherence measures): blood assay | |||
| Bessa23 | Concurrent | Coefficient of variation of tacrolimus trough levels obtained at days 10, 14, 21, and 28 d after Tx (n = 248) | At day 28c |
| Dobbels27 | Concurrent/prospective | Coefficient of variation of tacrolimus trough levels obtained at inclusion, 3, 6, 9, and 15 mo (between 2 and 5 measurements; n = 368) | At inclusionc |
| Eisenga29 | Concurrent/prospective | Coefficient of variation of tacrolimus levels 3 to 12 mo after Tx (between 2 and 4 measurements) (n = 1795) | At inclusion (1st available measurement post-Tx) |
| Godinas30 | Concurrent/prospective | Coefficient of variation of 3 prior tacrolimus trough levels (n = 498) | At inclusion |
| Gustavsen 231 | Concurrent/prospective | Coefficient of variation of 6 tacrolimus levels 6–9 wks after Tx (n = 570) | At week 8c |
| Košťálová22 | Prospective | Coefficient of variation of 7 tacrolimus trough levels at consecutive visits between 3 and 22 mo apart (n = 1635) | At inclusion |
| Lieb8 | Retrospective/concurrent | Coefficient of variation of tacrolimus of trough levels at inclusion + 3 antecedent measures (n = 302) | At inclusion |
| Schäfer11 | Prospective | Coefficient of variation of tacrolimus trough levels right before inclusion till end of EM measurement (between 2 and 17 measurements; n = 306) | At inclusion |
| Scheel38,39 | Retrospective | Coefficient of variation of 4 tacrolimus trough levels within the last 12 mo before BAASIS measurement (between 4 and 43 measurements; n = 2058) | At inclusion |
| Tielen40,41 | Concurrent | Coefficient of variation of tacrolimus blood levels at inclusion and 2 prior weeks (between 4 and 10 measurements; n = 572) | At inclusion |
| Validation analysis of the relationship of the BAASIS to other variables (part 1: other adherence measures): collateral report | |||
| Denhaerynck12 | Retrospective/concurrent | Physician and nurse estimates, blinded to patient self-report – 1 excellent; 2 fair; 3 poor adherence; dichotomized into adherent (1) and NA (2 and 3) | At inclusion |
| Dobbels27 | Retrospective/concurrent | Physician and nurse estimates, blinded to patient self-report – 1 excellent; 2 fair; 3 poor adherence; dichotomized into adherent (1) and NA (2 and 3) | At inclusion |
| Gustavsen31 | Retrospective/concurrent | Physician/nurse estimate – 1 excellent, 2 suboptimal, 3 poor adherence, dichotomized into adherent (1) and NA (2 and 3) | At inclusion |
| Lieb8 | Retrospective/concurrent | Physician estimate – 1 = very good adherence to 5 = very poor adherence, dichotomized into adherent (1) and NA (2–5) | At inclusion |
| Marsicano9,34 | Retrospective/concurrent | Assistant physician and nurse estimates, blinded to patient self-report – 1 good, 2 fair, 3 poor adherence, dichotomized into adherent (1) and NA (2 and 3) | At inclusion |
| Scheel38,39 | Retrospective/ concurrent | Physician estimate, blinded to patient self-report – 1 = very good adherence to 5 = very poor adherence, dichotomized into adherent (1) and NA (2–5) | At inclusion |
| Sanders-Pinheiro36 | Retrospective/concurrent | Nephrologist and nurse estimates (one or both), blinded to patient’s self-report – binary score | At inclusion |
| Schäfer11 | Retrospective/concurrent | Several physicians’ and several nurses’ estimates, blinded to patient’s self-report – 1 good, 2 fair, 3 poor adherence, dichotomized into adherent and NA if at least one of the physicians or nurses considered the patient not having good adherence | At inclusion |
| Schmid37 | Retrospective/concurrent | Physician and nurse estimates, blinded to patient’s self-report – 1 good, 2 fair, 3 poor adherence, dichotomized into adherent (1) and NA (2 and 3) | At inclusion |
| Silva35 | Retrospective/concurrent | Assistant physician and nurse estimates, blinded to patient’s self-report – 1 good, 2 fair, 3 poor adherence, dichotomized into adherent (1) and NA (2 and 3) | At inclusion |
| Validation analysis of the relationship of the BAASIS to other variables (part 2: psycho-behavioral constructs): cognitive behavioral theory | |||
| Denhaerynck12 | Concurrent | Integrative Model of Behavioral Prediction (barriers, intention, self-efficacy, beliefs, norms) | At inclusion |
| Dobbels27 | Concurrent | Integrative Model of Behavioral Prediction (barriers) | At inclusion and 15 mosd |
| Ducci28 | Concurrent | Integrative Model of Behavioral Prediction (barriers, intention, self-efficacy, beliefs, norms) | At inclusion |
| Godinas30 | Concurrent | Integrative Model of Behavioral Prediction (barriers) | At inclusion |
| Schmid37 | Concurrent | Integrative Model of Behavioral Prediction (barriers, intention, self-efficacy, beliefs, norms) | At inclusion |
| Schäfer11 | Concurrent | Integrative Model of Behavioral Prediction (self-efficacy, beliefs) | At inclusion |
| Tielen40,41 | Concurrent | Integrative Model of Behavioral Prediction (self-efficacy, beliefs) | At inclusion, 6, and 18 mo |
| Košťálová22 | Concurrent | Integrative Model of Behavioral Prediction (beliefs) | At inclusion |
| Validation analysis of the relationship of the BAASIS to other variables (part 2: psycho-behavioral constructs): depressive symptoms | |||
| Burkhalter24 | Concurrent | Depressive symptomatology: Depression, Anxiety, and Stress Scale | At inclusion |
| De Geest25 | Prospective | Depressive symptomatology: Depression, Anxiety, and Stress Scale | NA predicted by depressive symptoms at previous visit |
| Denhaerynck12 | Concurrent | Hospital anxiety and depression scale (depression part) | At inclusion |
| Liu32 | Concurrent | Hospital anxiety and depression scale (depression part) | At inclusion |
| Scheel38,39 | Concurrent | Hospital anxiety and depression scale (depression part) | At inclusion |
| Schäfer11 | Concurrent | Beck depression inventory | At inclusion |
| Validation analysis of the relationship of the BAASIS to other variables (part 3: responsiveness to adherence-enhancing interventions) | |||
| Bessa23 | Postintervention assessments comparison of intervention vs control group (original primary outcome: CV%) | Days 28 and 90 | |
| Dobbels27 | Postintervention assessments comparison of intervention vs control group (original primary outcome: EM) | Months 6, 9, and 15 | |
| Low33 | Postintervention assessments comparison of intervention vs control group (original primary outcome: EM) | Months 3, 6, 9, and 12 | |
| Abedini42 | Postconversion vs inclusion assessments | Inclusion, months 1, 3, 6, and 12 | |
| Beckebaum43 | Postconversion vs inclusion assessments | Inclusion, month 12 | |
| Doesch44,45 | Postconversion vs inclusion assessments | Inclusion, months 4 and 8 | |
| Lehner47 | Postconversion vs inclusion assessments (paired data unknown) | Inclusion, month 18 | |
| Fellström46 | Postconversion vs inclusion assessments | Inclusion, months 3, 6, and 12 | |
| Godinas30 | Postconversion vs inclusion assessments | Inclusion, month 12 | |
| Valente48 | Postconversion vs inclusion assessments (paired data unknown) | Inclusion, month 6 | |
| Validation analysis of the internal structure of the BAASIS | |||
| Studies with individual participant data | All available data points (see Table 2) | ||
| Reliability analysis of stability over time of individual responses | |||
| Bessa23 | Patient number as a random intercept | Day 28 and 90c | |
| De Geest25,26 | Patient number as a random intercept | Inclusion, year 1 and yearly visits | |
| Dobbels27 | Patient number as a random intercept | Inclusion, month 3, 6, 9, and 15d | |
| Eisenga29 | Patient number as a random intercept | Inclusion, month 3, 6, 12, 24, 36, 60 | |
| Gustavsen31 | Patient number as a random intercept | Week 8 and year 1c | |
| Lieb8 | Patient number as a random intercept | Inclusion and six 2-weekly visits | |
| Low33 | Patient number as a random intercept | Inclusion and four 3-monthly visitsc | |
| Tielen40,41 | Patient number as a random intercept | Inclusion, month 6 and 18 | |
Concurrent means that the study falls within the recall period of the BAASIS. Retrospective means that the study falls before the recall period of the BAASIS. Prospective means that the assay was done after the BAASIS measurement.
aAdapted to each research question pertaining to the 4-wk recall period for NA during the implementation phase.
bBaseline data are not relevant for concurrent adherence testing, because EM is not yet available for the prior month.
cControl group only.
dControl group, preallocated, and nonallocated participants.
BAASIS, Basel Assessment of Adherence to Immunosuppressive Medications Scale; CV%, coefficient of variation; EM, electronic monitoring; HTx, heart transplant; KTx, kidney transplant; LiTx, liver transplant; LuTx, lung transplant; NA, nonadherence; RCT, randomized controlled trial.