Abstract
Aim: The rates and reasons why clinicians decide not to follow recommendations from explicit-criteria have been studied scarce. We aimed to compare STOPP version 2 representing one of the most commonly used excplicit tool with the implicit comprehensive geriatric assessment mediated clinical evaluation considered as gold standard.
Methods: Two hundred and six (n = 206) outpatients ≥65 years old were included. The study was designed as retrospective, cross-sectional, and randomised. STOPP version 2 criteria were systematically used to assess pre-admission treatments followed by implicit clinical evaluation regarding two questions: Were the STOPP criteria recommendations valid for the individual patient and were there any potentially inappropriate-prescription other than depicted by STOPP version 2 criteria? The underlying reason(s) and associated clinical-features were noted.
Results: About 62.6% potentially inappropriate-prescriptions were identified (0.6 per-subject) according to systematic application of STOPP v2 while it was 53.4% (0.5 potentially inappropriate-prescriptions per subject) by clinician’s application of STOPP v2. Prevalence of non-compliance was 14.7% in 18 (21.7%) of 83 patients identified by systematic application. Suggestion to stop a drug was not accepted because of need of treatment despite likelihood of anticipated side-effects in about 2/3 and with no-anticipated side-effects in about 1/3 of non-compliances. Not following STOPP v2 was significantly associated with lower functional level. According to clinician’s implicit-evaluation, there were an extra 59.2% potentially inappropriate-prescriptions (0.6 per subject) in 80 (38.8%) patients yielding a total of 112.6% potentially inappropriate-prescription.
Conclusions: Most of the STOPP v2 directed drug cessations are decided valid by the clinicians. In patients with higher functional dependency, it is likely that they are not followed due to palliation focussed care/patient–family preferences. There may be as much as STOPP v2 identified potentially inappropriate-prescriptions by implicit evaluation in a significant percent of geriatric patients signifying need for comprehensive geriatric evaluation in practice.
1. Introduction
It is well known that the extent of polypharmacy and inappropriate medication use (IMU) increases by ageing. This iatrogenic problem puts the older adult in risk for a variety of adverse outcomes including functional detoriation [Citation1] and death [Citation2]. To fight with this giant problem, several different studies have been performed suggesting several distinct tools to assess and reduce IMU. These tools may be categorised as explicit (criteria-based) tools and implicit (judgment-based) tools. Explicit tools usually express indicators of IMU for several drugs and/or diseases or drugs to avoid lists. Implicit tools combine research data with clinical evaluation and consider preferences of the patients/caregivers as well to assess the quality of prescriptions [Citation3,Citation4]. While, interventions using explicit criteria have proved as important, effective strategies for reducing potentially inappropriate prescription (PIP) [Citation5], they lack assessment of overall individual characteristics of the patients. Comprehensive geriatric assessment (CGA) is the complete, global assessment of the older adult. Defined as technology of geriatrics, it allows better management of health problems [Citation6]. Not only the pharmacokinetic and pharmacodynamic changes associated with ageing but accompanying comorbidities, geriatric syndromes, functional deficits, limited life expectancy and patient preferences as well would affect the prescription quality in the older adults [Citation7]. Accordingly, implicit evaluation mediated by CGA is the major intervention that has demonstrated a reduction in the risk of adverse drug reactions in older adults [Citation4].
Explicit and implicit evaluation decisions would differ for some drugs, either as (i) the explicit criteria may not been accepted by the implicit clinical evaluation, or (ii) more drugs may be judged to be changed that were not identified by the explicit criteria set. To date, the rates and reasons why clinicians decide not to follow STOPP criteria to stop the drug have been studied scarce [Citation8] and to the best of our knowledge, there is not any report on the rate and underlying reasons for additional drug stops identified by the implicit evaluation. In this study, we aimed to compare one of the most commonly used explicit tool – STOPP version 2 (v2) – with the implicit CGA mediated clinical evaluation – considered as gold standard. We examined (i) the compliance with the recommendations of STOPP v2, (ii) the additional drug stops decided implicitly and (iii) the reasons for non-compliance and additional drug stops.
2. Materials and methods
This was a retrospective, cross-sectional and randomised study. The study participants were randomly selected among 667 older adults (≥65 years) admitted to geriatric outpatient clinic of the Istanbul University hospital between June 2000 and 2014 which were analysed for PIP with STOPP version2 criteria [Citation9]. This outpatient clinic accepts admission from all older adults ≥60 years regardless of their illnesses, co-morbidities and functional level. Three geriatricians experienced in geriatric prescription reviewed the patient files. Files were randomly selected from 667 participants’ files which were analysed for PIP and published before [Citation9]. First, STOPP v2 criteria were systematically used to assess pre-admission treatments. Afterwards, implicit CGA mediated evaluation was performed regarding two questions: (1) Were the STOPP criteria recommendations valid for the individual patient? (2) Were there any PIP other than depicted by STOPP v2 criteria? In cases of non-compliance to the explicit criterion or detection of PIP that was unidentified by the explicit tool, the underlying reason(s) were noted. In STOPP v2 tool, two new criteria were integrated which were noted as the drug indication criteria: “use of any drug prescribed without an evidence based clinical indication” and “any drug prescribed beyond the recommended duration where treatment duration is well defined” [Citation10]. They are self-evident and non-specific criteria with absolute global consensus. In the present study, we analysed and compared the specific criteria of STOPP v2 with the implicit evaluation. Oral nutritional supplements were not included in drug analysis. Comprehensive geriatric assessment was performed as follows: Functionality was evaluated by the six-item Katz activities of daily living (ADL) scores and eight-item Lawton instrumental activities of daily living (IADL) scores. The scores for each item were determined as 1, 2, and 3 in case the patient was totally dependent, partially dependent and independent for the activity, respectively [Citation11]. ADL total scores 6, 7–12 and 13–18 points and IADL total scores of 8, 9–16 and 17–24 points corresponded to dependency, partial dependency, and independency, respectively. Nutrition was evaluated by the Mini-Nutritional Assessment Short-Form (MNA-SF), which signifies malnutrition with 0–7 points, malnutrition risk with 8–11 points and normal nutrition with >11 points. Dementia diagnosis was made by clinical evaluation. Falls within the last year were evaluated by self-report. Depression was screened by the 15-item geriatric depression scale (GDS) short-form, and evaluated as ≥5 points suggestive for depression. Depression was not evaluated in patients with moderate or advanced dementia to ensure validity of the results. Informed consent was obtained from all participants or their related conservators. The study protocol was approved by the local ethics committee and conducted according to the guidelines laid down in the Declaration of Helsinki.
2.1. Statistical analysis
Descriptive statistics were generated for all study variables, including the mean and standard deviation for normally distributed continuous variables, the median for abnormally distributed variables and relative frequencies for categorical (qualitative) variables. Two groups were compared with independent sample t-test or Mann–Whitney U-tests when necessary. The χ2-test with Yates correction and Fisher’s exact test were used for 2 × 2 contingency tables when appropriate for non-numerical data. p values less than 0.05 were accepted as significant. The statistical analysis was carried out with the statistical package SPSS version 21.0 for Windows (SPSS Inc. Chicago, IL, USA).
3. Results
Two hundred and six patients files those were randomly selected from 667 files were reviewed. Mean age was 77.5 ± 6.6 years (65–95). 63.6% (n = 131) were female. The mean number of medications prescribed per patient was 6.3 ± 3.5 (median 6, interquartile range: 4). Disability was uncommon among the participants (86.2% and 53.7% were independent; 11.8% and 35% were partially dependent; only 2% and 11.3% were totally dependent in ADLs and IADLs, respectively). Overt malnutrition was present in 26.3%, dementia in 31.6%, depression 36.5% and falls in 38.8%. The characteristics of the study population is given in .
Table 1. Characteristics of the study population.
According to systematic application of STOPP criteria 40.3% (n = 83) of the patients were using at least one PIP. The total number of PIPs was 129 (62.6%) (0.6 PIP per subject). According to clinician’s application of STOPP criteria by considering the CGA-mediated implicit evaluation, 35.9% (n = 74) of the patients were using at least one PIP. The total number of PIPs was 110 (53.4%) (0.5 PIP per subject). There was non-compliance to the explicit decision in 21.7% of the STOPP identified patients (18 patients out of 83). The prevalence of non-compliance was 14.7% (19 PIPs out of 129). The results are outlined in . The suggestion to stop a drug was not accepted for 19 PIPs because of the need of treatment despite the likelihood of anticipated side effects in 13 PIPs and need of treatment in the absence of anticipated side effects in 6 PIPs (). Not following STOPP criteria was only significantly associated with lower functional level (14.4 vs 16.1 and 13.9 vs 17.3, for ADL and IADL, respectively; p = 0.01 for both) but not with other geriatric syndromes (i.e. nutritional status, cognitive/mood status or falls).
Table 2. The data on inappropriate precriptions by explicit evaluationTable Footnotea versus implicit evaluationTable Footnoteb.
Table 3. The criteria and reasons related to non-compliance to systematic application of STOPP version 2 criteria (n = 19).
According to clinician’s CGA mediated implicit evaluation, 38.8% (n = 80) of the patients were using at least one additional PIP that was not identified by any of the STOPP criteria. The total number of additionally identified PIPs was 122 (59.2%) (0.6 PIP per subject) yielding a total of 112.6% PIP (1.1 PIP per subject) by total implicit evaluation (). Presence of additional PIPs was only at borderline significance with higher age (78.6 vs 76.8 years) (p = 0.06).
The top three drugs that had been prescribed inappropriately but were not identified by STOPP version 2 criteria were vitamin-mineral-dietary supplements (22.1%), anti-hypertensives (17.2%) and proton pump inhibitors (10.7%) accounting for more than half of the cases. The details and reasons of inappropriate prescriptions that were not identified by STOPP v2 are given in .
Table 4. The details and reasons of inappropriate prescriptions that were not identified by STOPP version 2Table Footnotea (additional PIPs).
4. Discussion
Explicit criteria proved helpful to clinicians to improve quality of medication use [Citation5,Citation12]. However, they cannot replace implicit evaluation by which the clinicians evaluate the patient characteristics in detail to decide most useful drugs with maximum benefit but minimum side effects for the older adult considering all the factors involved, including costs [Citation13] and patient preferences and experiences [Citation14].
To our knowledge, there is only one study that analysed the rates and reasons why multidisciplinary geriatric teams with expertise in the use of drugs in older people decide not to follow the recommendations from explicit criteria [Citation8]. The former study was reported from Spain at 2015 by Lozano-Montoya et al. and included 346 patients aged 80 years or over admitted to the acute geriatric medicine unit of a university hospital with a mean age of 88.8 years. The present study is performed among 206 patients aged 65 years or over admitted to geriatric outpatient clinic of a university hospital with a mean age of 77.5 years. Our outpatient clinic serves for all older adults ≥60 years regardless of their illnesses, co-morbidities and functional level. Hence our population was not limited to pre-frail or frail participants but included fit, robust older adults as well. The disability rates were much higher in the former study (severe disability in ADLs and IADLs as 47.9% and 68.9%, respectively). Our study participants were younger, had higher functional level and clinically more stable. The former study examined compliance with the former version (version 1) of STOPP criteria. They reported higher amount of PIP (82.1% vs 62.6%) which we believe that was related to study population characteristics i.e. the higher age, poorer general condition and functional level. The suggestion to stop a drug was not accepted in 13.0%, while in our study it was not accepted in 14.7% which is a comparable yet a bit higher prevalence. Spain study did not accept to stop drugs because the team considered other therapeutic priorities in far most of them. In our study, non-compliances were also due to other therapeutic priorities in about 2/3 of the cases. Different from the Spain study, there were a significant percent of PIP cases causing no anticipated adverse effects resulting in non-compliance to the explicit criteria. We suggest that this is also due to better general condition of our study population as side effects are more common in the frailer older adults. There was not any PIP that had not resulted in the anticipated adverse effects in the former study. Thus, we suggest that presence of PIP cases without anticipated adverse effect in clinical follow-up resulted the implicit evaluation to designate comparable non-compliance in our study despite their better general condition. More research is needed to comment further if non-compliance to the explicit criteria (i.e. STOPPv2) is a common clinical decision in more robust older adults.
In the previous study, neither physical nor mental disabilities were associated with the degree of compliance to STOPP recommendations [Citation8] while we have found the non-compliance was associated with higher degree of disability. Our finding is in line with the usual practice of geriatricians. As the older adults become more dependent, quality of life issues based on the patient and family preferences become more important. Clinicians are more likely to choose a PIP in such patients to get the positive impact improving quality of life at the worth of the other potential side effect [Citation15–17].
We explored the presence of additional drugs to be stopped implicitly that had not been identified by the explicit criteria. To our knowledge our study represents the first study in the literature in this aspect. The additional drugs decided to be stopped by implicit evaluation was as much as the drugs identified with the clinician’s application of STOPP criteria (59.2% vs 53.4% PIPs) (). Hence, this study showed that explicit STOPP v2 criteria directed the clinician in nearly half of the PIPs. We suggest that while identifying half of the PIPs is valuable, this is clearly not enough suggesting that STOPP v2 should be modified for better clinical use locally. A national explicit criteria set taking these findings in account would be helpful and such a study is underway by our group. This is in accordance with practices throughout the world as some countries created their own explicit criteria set [Citation18,Citation19].
The explicitly undetected PIPs were mostly due to unnecessary use of vitamin–mineral–dietary supplements, anti-hypertensives and PPIs. Although further studies from different regions of the world is needed to see whether these drugs are commonly responsible for undetected PIPS in general, our study points out to the need for higher attention for these drugs in our practice. This is in line with global trends. It is reported that vitamin–mineral–dietary supplement [Citation20], antihypertensive [Citation21], PPI [Citation22] consumptions increased in older age in recent years. The potential side effects of vitamins, minerals and supplements are commonly overlooked by the health professionals and ignored by the patients/families. Inappropriate use of antihypertensive treatment may increase falls [Citation23] or mortality [Citation24]. The practice of unnecessary PPI use deserves also special attention considering multiple significant adverse effects (i.e. dementia, renal failure, and fractures) prevalent in older age and the recently reported increased mortality associated with PPI use [Citation25]. Of note, common to all inappropriate prescriptions, to say the least, they increase economic burden due to lack of benefit and decrease compliance to beneficial medications if they do not harm the health of the patient with other adverse effects.
In conclusion, our study suggests that while most of the STOPP v2 directed drug cessations are followed by the clinicians, it is likely that they are not followed for quality of life reasons or patient–family preferences in patients that are in need of palliative care with higher functional dependency. There may be as much as STOPP v2 identified PIPs by implicit evaluation signifying need for comprehensive geriatric evaluation in practice and generation of national explicit criteria set taking local practices in account to help as a more valid basis for practicing clinicians. It seems prescription practices concerning vitamin-mineral dietary supplements, anti-hypertensives and PPIs need more attention. Further studies from the aging world are needed to comment more on comparison of explicit versus implicit evaluations.
Disclosure statement
No potential conflict of interest was reported by the authors.
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