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Farm Hosp. 2009;33(5):269-80
Farmacia
HOSPITALARIA
Volumen 33. Número 5. Septiembre-Octubre 2009
ÓRGANO OFICIAL DE EXPRESIÓN CIENTÍFICA DE LA SOCIEDAD ESPAÑOLA DE FARMACIA HOSPITALARIA
Farmacia
HOSPITALARIA
Editorial
235 El reto de disminuir los costes en el tratamiento de la anemia renal
con factores eritropoyéticos
J. Hernández Jaras
237 Posicionamiento del farmacéutico de hospital ante la utilización de medicamentos
en condiciones diferentes a las autorizadas
O. Delgado, F. Puigventós y A. Clopés
Originales
240 Análisis de minimización de costes de fludarabina (Beneflur )
oral vs. intravenosa en España
J. Delgado, L. Febrer, D. Nieves, C. Piñol y M. Brosa
247 Impacto presupuestario de una combinación a dosis fija
de efavirenz-emtricitabina-tenofovir para tratamiento de pacientes
infectados por el virus de la inmunodeficiencia humana tipo 1
I. Oyagüez, M.A. Casado, M. Cotarelo, A. Ramírez-Arellano y J. Mallolas
257 Estudio de incidencia de los errores de medicación en los procesos
de utilización del medicamento: prescripción, transcripción, validación,
preparación, dispensación y administración en el ámbito hospitalario
L. Pastó-Cardona, C. Masuet-Aumatell, B. Bara-Oliván, I. Castro-Cels, A. Clopés-Estela,
F. Pàez-Vives, J.A. Schönenberger-Arnaiz, M.Q. Gorgas-Torner y C. Codina-Jané
269 Calidad de las recomendaciones farmacoterapéuticas de los procesos
asistenciales integrados en Andalucía
R.M. Muñoz Corte, R. García Estepa, B. Santos Ramos y F.J. Bautista Paloma
Artículo especial
281 Revisión de la legislación sobre la investigación clínica en el Sistema Nacional Salud
y los servicios de farmacia hospitalaria
N. Laguna-Goya, M.A. Serrano y C. Gómez-Chacón
Cartas al Director
285 Bivalirudina en trombocitopenia inducida por heparina
M. Gasol-Boncompte, B. Gracia-García, L. Pastó-Cardona y R. Jódar-Masanes
286 Crisis clónica generalizada asociada a vincristina en un caso pediátrico
M.C. Garzás-Martín de Almagro, A.I. Gago Sánchez, I. Fernández García y C. Zarza Verdugo
288 Sorafenib: eficacia frente a seguridad. Prevención del síndrome mano-pie
L. Delgado-Téllez, M.A. Campos Fernández de Sevilla y F. Tutau
•
www.elsevier.es/ farmhosp
289 Hepatitis asociada a infusiones acuosas de té verde: a propósito de un caso
P. Amariles, N. Angulo, J. Agudelo-Agudelo y G. Gaviria
•
www.elsevier.es/farmhosp
ORIGINAL ARTICLE
Quality of the pharmacotherapeutic recommendations
for the integrated care procedures in Andalusia
Rosa María Muñoz Corte, a, * Raúl García Estepa, b Bernardo Santos Ramos, a
and Francisco Javier Bautista Palomaa
a
Servicio de Farmacia, Hospit ales Universit arios Virgen del Rocío, Sevilla, Spain
Agencia de Evaluación de Tecnologías Sanit arias de Andalucía AETSA, Sevilla, Spain
b
Received April 2, 2009; accept ed June 15, 2009
KEYWORDS
Care procedures;
Healt h planning
guidelines;
Pharmacot herapeut ica
recommendat ions;
Healt h service
evaluat ion
Abstract
Obj ect ives: To evaluat e t he qualit y of t he pharmacot herapeut ic recommendat ions included in
t he Int egrat ed Care Processes (PAIs regarding it s init ials in Spanish) of t he Andalusian Minist ry of
Healt h, published up t o March 2008, t hrough t he design and validat ion of a t ool.
Met hods: The assessment t ool was designed based on similar inst rument s, specif ically t he
AGREE. Ot her crit eria included were t aken from various lit erat ure sources or were devised by
ourselves. The t ool was validat ed prior t o being used. Af t er applying it t o all t he PAIs, we
examined t he degree of compliance wit h t hese pharmacot herapeut ical crit eria, bot h as a whole
and by PAIs subgroups.
Resul t s: The developed tool is a questionnaire of 20 items, divided into 4 sections. The irst
section consists of the essential criteria, and the rest make reference to more speciic, non
essential criteria: deinition of the level of evidence, thoroughness of information and deinition
of i ndi cat ors. It was f ound t hat 4 of t he 60 PAIs do not cont ai n any t ype of t herapeut i c
recommendation. No PAI fulils all the items listed in the tool, however, 70 % of them fulil the
essent ial qualit y crit eria est ablished.
Concl usi ons: Ther e i s a gr eat var i abi l i t y i n t he cont ent of phar macot her apeut i cal
recommendat ions for each PAI. Once t he validit y of t he t ool has been proved, it could be used
t o assess t he qualit y of t he t herapeut ic recommendat ions in clinical pract ice guidelines.
© 2009 SEFH. Published by Elsevier España, S.L. All right s reserved.
*Corresponding aut hor.
E-mail address: rmunozdelacort [email protected] (R.M. Muñoz Cort e).
1130-6343/ $ - see front mat t er © 2009 SEFH. Published by Elsevier España, S.L. All right s reserved.
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270
PALABRAS CLAVE
Procesos
asist enciales;
Direct rices para la
planiicación en salud;
Recomendaciones
farmacot erapéut icas;
Evaluación de
servicios sanit arios
Muñoz Cort e RM et al
Calidad de las recomendaciones farmacoterapéuticas de los procesos asistenciales
integrados en Andalucía
Resumen
Obj et ivos: Evaluar, a t ravés del diseño y la validación de una herramient a, la calidad de las recomendaciones farmacot erapéut icas incluidas en los Procesos Asist enciales Int egrados (PAI) de
la Consej ería de Salud de la Junt a de Andalucía, publicados hast a marzo de 2008.
Mét odos: La herramient a de evaluación se diseñó a part ir de inst rument os similares, fundament alment e el Appraisal of Guidelines for Research and Evaluat ion. Ot ros crit erios incluidos provenían de diversas fuentes bibliográicas o fueron de elaboración propia. Previamente a su utilización, la herramient a f ue validada. Tras la aplicación a t odos los PAI, se analizó el grado de
cumplimient o de est os crit erios farmacot erapéut icos globalment e y por subgrupos de PAI.
Resul t ados: La herramient a elaborada consist e en un cuest ionario de 20 ít ems dividido en 4
bloques. El primer bloque corresponde a crit erios esenciales, el rest o hace referencia a crit erios
más especíicos y considerados no esenciales: deinición del nivel de evidencia, exhaustividad
de la información y deinición de indicadores. De los 60 PAI, 4 no contienen ningún tipo de recomendación terapéutica. Ningún PAI cumple el total de ítems recogidos en la herramienta; no
obstante, un 70 % de ellos cumple los criterios esenciales de calidad establecidos.
Conclusiones: Hay una gran variabilidad en cuant o al cont enido de recomendaciones farmacot erapéut icas de cada PAI. Una vez demost rada la validez de la herramient a diseñada, podría ut ilizarse para valorar la calidad de las recomendaciones t erapéut icas en guías de práct ica clínica.
© 2009 SEFH. Publicado por Elsevier España, S.L. Todos los derechos reservados.
Introduction
Organising medical assist ance by means of clinical
channels, prot ocols or ot her t ools is a const ant process
t hat is found in many healt h services in West ern count ries. 1
Examples include t he Scot t ish Int ercollegiat e Guidelines
Net work2 and t he Guidances of t he Nat ional Inst it ut e for
Healt h and Clinical Excellence3 in t he Unit ed Kingdom,
t he Healt h Care Order Set from t he Inst it ut e for Clinical
Syst em Improvement 4 in t he Unit ed St at es, t he Linee Guida
Aziendali of Ist it ut o Superiore di Sanit à in It aly, 5 t he miniHTA (Healt h Technology Assessment ) of t he Danish Cent re for
Evaluat ion and Healt h Technology Assessment in Denmark, 6
t he MUMM programme (Managed Upt ake of Medical Met hods)
in Finland, 7 t he Consensus Conference Guidelines of t he
Haut e Aut orit é de Sant é in France, 8 t he General Guidelines
for Assessing, Approving & Int roducing New Procedures int o
a Hospit al or Healt h Service of t he College of Surgeons of
Aust ralia and New Zealand (Aust ralia) 9 or t he Handbook for
t he Preparat ion of Explicit Evidence-Based Clinical Pract ice
Guidelines (New Zealand). 10
In Andalusia, t he Regional Minist ry of Healt h has chosen
int egrat ed care processes (PAI) as it s model. Process
management in t he Andalusian public healt h syst em (SSPA)
is an inst rument used t o analyse t he many component s
involved in providing healt h services wit h a view t o
organising work lows, integrating up-to-date knowledge
and placing a cert ain emphasis on t he result s obt ained.
It t herefore keeps users’ and professionals’ expect at ions
in mind, and at t empt s t o decrease t he variabilit y of
professionals’ act ions in order t o reach a reasonable degree
of homogeneit y. In t his way, we can offer users high-qualit y
healt h care services. 11
The SSPA has placed a special emphasis on implement ing
int egrat ed care processes, part icularly wit h regard t o
recommendat ions’ applicabilit y and force from a global
st andpoint . However, according t o our knowledge t o dat e,
t heir pharmacot herapeut ical recommendat ions have not
been evaluat ed.
Alt hough t hey were not creat ed t o be clinical pract ice
guides (CPG) as such, it is import ant t o evaluat e t he
incorporat ion of t he concept of rat ional use of a drug as
one of it s qualit y guidelines, since t he management of t hat
medicat ion may be assist ed or harmed by t he way t hese
general strategic concepts are deined.12
The purpose of t his st udy was t o evaluat e t he qualit y of
pharmacot herapy recommendat ions for all PAIs published
by t he Andalusian Regional Minist ry of Healt h as of March
2008.
Methods
We identiied all integrated care processes published on
t he Andalusian Regional Minist ry of Healt h’s Web page as
of March 2008.
We decided t o design our own inst rument for designing
pharmacot herapy recommendat ions, since no adequat e
inst rument s could be found in a preliminary bibliographical
search. This t ool consist s of a simple checklist t o evaluat e
qualit at ive aspect s, such as t he presence or absence of
recommendat ions, t heir compliance wit h t he evidence-
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Quality of the pharmacotherapeutic recommendations for the integrated care procedures in Andalusia
based medicine paradigm, formal and met hodological fact ors
and t he presence or absence of indicat ors. In addit ion, it
will also be useful for measuring quant it at ive differences
bet ween int egrat ed care processes (exhaust iveness of t he
recommendat ions).
When designing t he quest ionnaire, t he research t eam had
t he help of a panel of expert s consist ing of seven specialist s
in hospit al pharmacy wit h experience in pharmacot herapy
and pharmaceut ical care in different depart ment s (int ernal
medicine, surgery, psychiat ry, respirat ory medicine,
ot orhinolaryngology, and oncology).
It ems on t he quest ionnaire were eit her based on a
simpliied, adapted form of the AGREE tool (Appraisal
of Guidelines for Research and Evaluat ion) 13 and a t ool
designed by t he FUINSA t ask force on t herapeut ic guides, 14
or else t hey were elaborat ed by t he panel of expert s. All
crit eria were designed for dichot omous answers.
Before crit eria were used, an evaluat ion was carried out
t o consider t heir pert inence, capacit y for different iat ion,
reproducibilit y and writ t en descript ion. The quest ionnaire
was independent ly applied t o four randomly-select ed
processes in t wo different rounds (scheduled one week
apart ). This was done by t he 4 main researchers for t he 4
chosen processes, and t hen a concordance analysis was run
for t he result s gat hered by each of t he researchers (kappa
index). Constant values higher than 0.7 were considered
accept able.
Once t he validat ion had been made, 2 independent
evaluat ors applied t he quest ionnaire t o all of t he int egrat ed
care processes t hat were available at t he st art of t he st udy.
Discrepancies were resolved by means of t he consensus of
t he ent ire research t eam.
We performed a descript ive st at ist ical analysis for t he
frequency wit h which one crit erion was met for all processes
(percent age of t he processes t hat comply wit h each of t he
crit eria) as well as for t he frequency wit h which t he set
crit eria were met in each process (percent age of it ems t hat
are met out of t he list of t ot al it ems).
The processes were subsequent ly grouped according
to ield, and the general analysis was repeated for each
ield. The assigned ields were: medical, surgical and other
(having t o do wit h prevent ion or diagnosis). In addit ion,
the medical ield was divided into specialties: these were
assigned according t o t he t ask force t hat had designed each
process.
Results
The inished questionnaire contained a total of 20 items
classiied into 4 basic blocks: essential criteria, evidence
level deinition, exhaustiveness of the information, and
indicator deinition (Table 1).
The 4 processes chosen at random for int ernal validat ion
of t he t ool were t he following: hip art hroplast y, breast
cancer, pulmonary t hromboembolism, and non-ST elevat ion
acut e coronary syndrome. Table 2 list s t he result s from t he
concordance analysis.
A total of 60 integrated care processes were identiied for
t he st udy; of t his t ot al, 43 processes were assigned t o t he
medical ield, 12 to the surgical ield, and 5 to “other.”
For t he t ot al set , mean compliance for t he t ot al it ems
271
was 9.8 out of 20. The median value was 9.5 (int erquart ile
range, 6-14).
Wit h regard t o t he essent ial crit eria block on t he
quest ionnaire, 42 of t he 60 int egrat ed care processes
cont ained recommendat ions for more t han half of t he
clinical examples, and 14 had a recommendat ion for at
least one example. Only 4 processes were accompanied by
no recommendat ions.
Wit h respect t o t he second block (evidence level
deinition), only 10 processes indicated the evidence level
for more t han half of t heir recommendat ions; 12 processes
indicat ed it for at least one recommendat ion; and 38 never
indicat ed t he evidence level.
The mean for criteria met in the “exhaustiveness of
information” block was 6.1 out of that block’s total of 13
items. Indicators were included in 27 of the 60 processes
(45%).
Table 3 shows t he quest ionnaire’s degree of compliance
for each of t he individual processes.
None of t he int egrat ed care processes met all of
t he it ems list ed in t he inst rument , and 4 cont ained no
pharmacot herapy recommendat ions what soever.
Table 4 shows t he percent age of t he processes in which
each one of the criteria is fulilled. The criteria that were
met t he least were t he one referring t o bibliographical
references for more t han half of t he pharmacot herapeut ical
recommendations (7 of the 60 processes), followed
by t he one referring t o a pharmacological algorit hm
(8 processes).
Table 5 shows t he analysis of t he number of crit eria t he
questionnaire met based on the ield to which each PAI
belongs.
The study broken down by ields shows that the percentage
of t he crit eria (essent ial or non-essent ial) is higher in
medical PAIs than in surgical PAIs. Within the medical ield,
t he processes assigned t o t he cardiology specialt y had t he
highest degree of compliance, wit h a mean of 13 out of
20 crit eria (dat a not shown).
Discussion
As PAIs const it ut e one of t he main st rat egies for improving
care quality and proper integration of up-to-date scientiic
knowledge in Andalusia, we would hope t hat t hey would
incorporat e correct drug use as a basic st rat egy t oward
decreasing variabilit y in t he resources used and result s
obt ained. 15 In t his respect , nearly all of t he PAIs included
pharmacotherapy recommendations, and 70% included
t hem for most clinical examples. This may be considered a
sat isfact ory quant it at ive result .
However, t he formal qualit y of t hese recommendat ions
is poorer, alt hough we must point out t hat we only
st udied t he formal st ruct ure of t he PAIs’ pharmacot herapy
recommendat ions, and not t heir validit y and congruence
with scientiic evidence. For this reason, this study does
not begin t o evaluat e t his last quest ion, alt hough it should
be a necessary requirement for ensuring t he suit abilit y of a
recommendat ion. 16
Very few PAIs earn high scores for all of t he formal
qualit y component s t hat we considered in our evaluat ion.
In part icular, only a few PAIs indicat e t he evidence level
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272
Table 1.
Muñoz Cort e RM et al
Crit eria included in t he evaluat ion t ool used in t he present st udy
It em
Explanat ion in our t ool
Source
Original wording
Essential criteria
Does it cont ain t reat ment
recommendat ions?
Answer yes if t here is at least one
recommendat ion
Own source
Does it cont ain t reat ment
recommendat ions for most
clinical examples?
Own source
Answer yes if pharmacot herapy
recommendat ions are present
for more t han half of t he examples.
Examples are considered t o be t hose
clinical sit uat ions or pat ient groups
t hat are clearly set apart in t he process
due t o t heir aet iology, hist ology,
comorbidit y, prognosis or ot her
variables
Deining evidence level
Does it indicat e t he level
of evidence for a
recommendat ion?
Answer yes if t here is at least one
reference
AGREE13
Crit eria for select ing
evidence are clearly
described
Does it indicat e t he level
of evidence for most
recommendat ions?
Answer yes if t here are references
in more t han half of t he
recommendat ions as described
above
AGREE13
Crit eria for select ing
evidence are clearly
described
Does it provide references
for it s recommendat ion(s)?
Answer yes if at least one pharmacological AGREE13
recommendat ion can be linked t o a
reference
An explicit relat ionship
exist s bet ween each
of t he recommendat ions
and t he evidence
upon which t hey
are based
Does it provide references
for most of it s
recommendat ions?
Answer yes if more t han half of t he
recommendat ions can be linked t o at
least one bibliographic reference
An explicit relat ionship
exist s bet ween each
of t he recommendat ions
and t he evidence upon
which t hey are based
AGREE13
Exhaustiveness of the information
Do t he recommendat ions list
speciic drugs?
Answer yes if at least one recommendat ion Own source
is list ed
Are guidelines for dosage,
administ rat ion frequency,
and t reat ment durat ion
provided?
Answer yes if at least one recommendat ion Moreno et al 14
is list ed
It lists speciic
recommendat ions
for each t reat ment ,
giving alt ernat ives,
dosage and durat ion
range where applicable,
and pat ient groups in
which t he t reat ment is
indicat ed or
cont raindicat ed
Are irst-choice
and alt ernat ive
medicat ions list ed?
Answer yes if at least one recommendat ion AGREE13
is list ed. Drugs of choice are underst ood
t o be such due t o reasons of
effect iveness/ safet y or cost effect iveness
The different opt ions for
t reat ing t he disease or
condit ion are clearly
present ed
(Cont inued on next page)
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Quality of the pharmacotherapeutic recommendations for the integrated care procedures in Andalusia
Table 1.
Crit eria included in t he evaluat ion t ool used in t he present st udy
It em
Are some medicat ions or
medicat ion groups
speciically advised against?
Explanat ion in our t ool
Answer yes if t here is at least one
recommendat ion of t his t ype due t o
reasons of effect iveness/ safet y or
cost -effect iveness
273
(Cont inuat ion)
Source
Moreno et al 14
Original wording
It lists speciic
recommendat ions
for each t reat ment ,
giving alt ernat ives,
dosage and durat ion
range where applicable,
and pat ient groups in
which t he t reat ment is
indicat ed or
cont raindicat ed
Moreno et al 14
Answer yes if t he recommendat ions
Does it list drugs for speciic
(whet her t hey are t he same or
pat ient subgroups or special
personalised) consider pharmacot herapy
clinical sit uat ions?
broken down by different clinical
sit uat ions.
In part icular, evaluat ors should look for
RF
renal failure, liver failure or pregnancy
LF
(if applicable) as t he most generally
Pregnancy
pert inent sit uat ions
Clearly deine the health
problems covered by
t he guide:
a) Types of healt h problems;
b) If possible comorbidit ies
or t he evolving phase of
t he different problems are
considered;
c) If it considers
physiopat hological
or clinical circumst ances
that might inluence
or change t he choice
of t he proposed
t reat ment s for different
healt h problems
Does it specify different
t reat ment s for different
st at es of t he same disease?
Answer yes if t here are different
t herapeut ic recommendat ions for
different diagnost ic or prognost ic
cat egories
Moreno et al 14
Clearly deine the health
problems covered by t he
guide:
a) Types of healt h problems;
b) If possible comorbidit ies
or t he evolving phase of
t he different problems are
considered;
c) If it considers
physiopat hological
or clinical circumst ances
that might inluence
or change t he choice
of t he proposed
t reat ment s for different
healt h problems
Is a goal deined in order to
evaluat e t he effect iveness
of t he pharmacot herapy?
An analyt ical value, a funct ional
level or a cert ain score on a
subj ect ive scale. This refers t o
t he ent ire process or it s main
morbidit y, ex. mort alit y, change
in funct ional st at e, decrease in
hospit alisat ions, normalisat ion
of CD4 levels, improved glycosylat ed
haemoglobin
Own source
(Cont inued on next page)
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274
Table 1.
Muñoz Cort e RM et al
Crit eria included in t he evaluat ion t ool used in t he present st udy
It em
Does it deine a follow-up
met hod t o check t he
effect iveness of a
recommended drug?
Explanat ion in our t ool
(Cont inuación)
Source
Original wording
Own source
A follow-up met hod t hat helps
us det ect t he effect iveness of
each t reat ment , ex.
VAS score for pain,
INR for t hromboembolic
prophylaxis, et c
Are possible adverse react ions Answer yes if t hey are list ed for at least
deined?
t hose cases in which adverse react ions
are known for t heir frequency
or severit y
AGREE13
Does it deine methods for
prevent ing, minimising,
or communicat ing adverse
react ions t o t he drug?
Ex. Use of paracetamol to alleviate lu-like Own source
sympt oms of int erferon 2b
Are drug-drug, drug-food,
and drug-diagnost ic t est
int eract ions considered?
Answer yes if at least t he most well-known Own source
int eract ion cases are list ed
Does it ment ion nonpharmacological t reat ment
alt ernat ives?
Answer yes if t here is at least one
recommendat ion of t his t ype
Does it deine a
pharmacological t reat ment
algorit hm?
Answer yes if there is at least one speciic Moreno et al 14
algorit hm for pharmacot herapy. General
algorit hms in which one of t he out comes
ment ions pharmacological t reat ment are
not included
AGREE13
The recommendat ions were
writ t en wit h a view t o
health beneits, side
effect s and risks
The different opt ions
for t reat ing t he disease
or condit ion are clearly
present ed
Consider whet her list ing
recommendat ions
is based on t ools t hat
facilit at e t heir
underst anding and use
in clinical pract ice
Indicator deinition
Are indicators deined in order Answer yes if at least one indicat or
direct ly relat ed t o pharmacot herapy
t o evaluat e proper use of
appears
medicat ions in t he care
process?
AGREE13
The guide offers a list of key
crit eria wit h a view t o
performing follow-up or
audit ing
AGREE indicat es Appraisal of Guidelines for Research and Evaluat ion; INR, int ernat ional normalised rat io. VAS, visual analogue scale.
and t he bibliographic references for t he pharmacot herapy
recommendat ions. This fact does not mean t hat t he
recommendat ions are not suit able; rat her, it probably means
t hat t he PAI’s met hodology inst ruct ions did not priorit ise
references as an indispensable component . While lack of
references is really a format problem, it does subt ract a
great deal of credibilit y from t he recommendat ions.
In cont rast , relevant fact ors, such as indicat ing dosage
guidelines, selecting irst-choice over alternative drugs
and t he ment ion of non-pharmacological alt ernat ives are
present in most PAIs. We should ment ion t hat different iat ing
between irst-choice and alternative treatments is a
j udgment call for t he PAI aut hors, and one which frequent ly
does not appear in ot her document s. Priorit ising cert ain
medicat ions over ot hers due t o reasons involving t he risk/
beneit relationship, the best available evidence or the costeffect iveness rat io is a process of evaluat ing and deciding
bet ween alt ernat ives. This requires proper met hodology
and rigorous analysis. Last ly, t he high frequency wit h which
non-pharmacological alt ernat ives are included point s
t oward t he progress made in demedicalising many care
processes, in keeping wit h demand in recent years. 17-19
On t he ot her hand, fact ors having t o do wit h t he
inclusion of recommendat ions on int eract ions and how t o
minimise adverse react ions have a low compliance rat e;
t his may be due t o t he complexit y of t hese subj ect s and
t heir scarce ment ion in clinical pract ice guidelines. The
low rat e of inclusion for an algorit hm in t he t reat ment
recommendat ions is less underst andable, as t his is a very
useful decision-making t ool, in addit ion t o being a way of
synt hesising recommendat ions t hat is very relevant t o t he
st ruct ure of t he PAIs t hemselves.
Only half of t he PAIs include evaluat ion indicat ors for
following pharmacot herapy recommendat ions, which shows
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Quality of the pharmacotherapeutic recommendations for the integrated care procedures in Andalusia
Table 2.
Int ernal validat ion of quest ionnaire
Process
Evaluat or 2
Evaluat or 3
Evaluat or 4
Non-ST elevation acute coronary syndrome
Evaluat or 1
k=0.945
k=0.835
Evaluat or 2
k=0.891
Evaluat or 3
k=0.835
k=0.891
k=1
Pulmonary thromboembolism
Evaluat or 1
k=0.944
Evaluat or 2
Evaluat or 3
k=0.864
k=0.823
k=0.864
k=0.823
k=1
Breast cancer
Evaluat or 1
Evaluat or 2
Evaluat or 3
k=1
k=0.938
k=0.938
k=0.938
k=0.938
k=1
Hip arthroplasty
Evaluat or 1
Evaluat or 2
Evaluat or 3
k=1
k=0.8
k=0.8
k=0.8
k=0.8
k=1
Not e: from a st at ist ical viewpoint , concordance is t hought t o
be good where kappa value >0.7.
j ust how lit t le import ance is given t o t his aspect of PAI
development .
Wit h respect t o analysis by area, as we might have
expect ed, t he highest percent age of compliance wit h
criteria corresponded to the medical ield rather than the
surgical ield, due to the differing roles of pharmacotherapy
in these ields. With regard to results broken down by
medical specialt y, t he cardiology dat a st and out ; alt hough
t hey score higher t han t he rest , as a t ot al, t hey barely
reach a 65% compliance level for all of the criteria (mean
of compliance levels for t he 8 processes pert aining t o t his
specialt y).
Several published st udies are available which evaluat e
CPGs in Spain, although they do not speciically address
pharmacot herapy recommendat ions. In general, t hey st at e
t hat t he formal qualit y of CPGs in Spain is low, as shown by
our result s.
Capdevilla et al 20 use t he AGREE t ool t o evaluat e several
CPGs for some of t he most common care processes in t he
area of t he Commission of Medicine and Specialt ies relat ed
t o t he Cat alan Council of Healt h Science Specialt ies,
Regional government of Cat alonia (Generalit at ). Only
one of t he 12 reviewed CPGs had a score of higher t han
50% for all areas covered by the instrument. Graham et
al 21 also used an adapt at ion of t he AGREE t ool t o evaluat e
t he qualit y of a set of CPGs published in Canada in 1998.
Their result s were bet t er t han ours, but t his could be due t o
2 reasons: irstly, their quality assessment was overall, and
not of j ust t he t reat ment recommendat ions, and secondly,
because in our case, we were examining t he CPGs. In a
2004 st udy, Navarro Puert o et al 22 analysed t he qualit y of 61
Spanish CPGs using t he AGREE t ool and found t hat , except
for t he areas of scope and independence, t he vast maj orit y
received scores below 50% in the other areas.
275
We were unable to ind a questionnaire that was
complet ely suit ed t o t he obj ect ives of t his st udy in t he
published lit erat ure. First of all, t he AGREE t ool is t he
assessment t ool of reference for CPGs, but it is not designed
to speciically assess pharmacotherapy recommendations,
and it is dificult to adapt it for use with other types of
prot ocols such as PAIs. 23 Likewise, ot her t ools list ed by Rico
et al 24 in t heir review of different crit eria for evaluat ing CPGs
were not applicable t o our st udy. The proj ect by t he FUINSA
st udy group, on t he ot her hand, does est ablish det ailed
assessment crit eria for pharmacot herapy guidelines, but
it is not complet ely applicable t o our proj ect ’s obj ect ive,
which is t o evaluat e pharmacot herapy recommendat ions
found wit hin broader guides. 14 However, as st at ed above,
t his proj ect and t he AGREE t ool were essent ial precedent s
for t he creat ion of our own quest ionnaire.
We therefore opted for elaborating a speciic questionnaire
in which t he aut hors est ablished cert ain crit eria, which
may be t he main weakness of our st udy. However, before
t he crit eria were applied, we validat ed t hem wit h help
from a panel of expert s, which may have decreased t heir
subjectivity. Among the included criteria, we ind some that
were considered of part icular import ance, and we included
t hem t wice in order t o evaluat e bot h t heir qualit at ive and
quant it at ive cont ribut ions; t he purpose of t his st ep was
t o set apart t he PAIs t hat did not comply wit h a cert ain
crit erion at all. In addit ion, we evaluat ed excellence for
guides t hat complied wit h at least half of t he guidelines,
t hereby select ing processes t hat considered most of t he
crit eria.
We did not consider AGREE crit eria having t o do wit h
t he guide’s overall obj ect ive and pat ient descript ion and
part icipat ion in t he guide (guide’s clinical obj ect ives,
clinical aspect s covered in t he guide and t he pat ient s for
whom t he CPG is int ended) because t hese are very general
t opics. Alt hough sharing a decision wit h t he pat ient is an
increasingly import ant component of a qualit y t reat ment
recommendat ion, we feel t hat including t his fact or in t he
assessment would complicat e t he analysis excessively.
Ot her crit eria from t he AGREE t ool t hat were not included
were t hose referring t o clarit y and present at ion; we
consider t hese mat t ers as secondary t o t he main purpose
of our st udy.
On t he ot her hand, it is t rue t hat t he low number of PAIs
which met some of t hese crit eria (such as t he exist ence of
a pharmacological algorithm, the deinition of methods for
prevent ing or predict ing adverse react ions or descript ion of
potential interactions) may demonstrate that deinitions on
our side were excessively st rict . Also, t he inclusion of more
crit eria on non-pharmacological alt ernat ives could have
permit t ed a bet t er score for surgical processes and t hose in
the “other” category (preventative or diagnostic).
Anot her possible limit at ion of our st udy can be found
in t he analysis by area and medical specialt y. PAIs are
inherent ly designed t o be mult i-disciplinary and mult ilevel, and for this reason, assigning each PAI to a speciic
area and specialt y could in many cases have been imprecise
and dependent on t he evaluat ors’ j udgment .
PAIs are fundament al t ools for organising int egrat ion of
primary and specialist care, placing t he pat ient at t he cent re
of t he syst em and describing t he best possible pract ice for
integrated care of patients with deined morbidity processes
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276
Muñoz Cort e RM et al
Table 3.
Number of crit eria met by each int egrat ed care process
Processes
Anaemia
St able angina
(chest pain)
Anxiet y depression,
somat isat ion
disorders
Arrhyt hmias
Knee and hip
ost eoart hrit is
Adult ast hma
Childhood ast hma
Cerebrovascular event
Care for pat ient s wit h
mult iple illnesses
Severe t rauma care
Cervix/ ut erus
cancer
Skin cancer
Skin cancer
Headaches
Palliat ive care
Dement ia
Diabet es mellit us
t ype 1
Diabet es mellit us
t ype 2
Dysphonia
Thyroid dysfunct ion
Dyspepsia
Abdominal pain
Non-oncological
chronic pain
Generic (unafiliated)
chest pain
Pregnancy, childbirt h
and post part um
Chronic obst ruct ive
pulmonary disease
Fibromyalgia
Int ermediat e-lengt h
fever
Abnormal ut erine
haemorrhaging
Viral hepat it is
Benign prost at e
hypert rophy.
Prost at e cancer
ST-elevat ion AMI
(chest pain)
Heart failure
Ot it is media
Vascular risk
All crit eria
(n=20) No. (%)
16 (80)
11 (55)
2 (10)
Essent ial
crit eria
Mainly
Mainly
Occasionally
Evidence
Exhaust iveness of
level
t he informat ion
deinition, %
(n=13) No. (%)
25
25
12 (92)
7 (54)
Indicat or
deinition
Specialt y
Yes
Yes
Family medicine
Cardiology
0
1 (8)
No
Family medicine
75
75
11 (85)
13 (100)
Yes
Yes
Cardiology
Rheumat ology
15 (75)
16 (80)
Mainly
Mainly
15 (75)
15 (75)
15 (75)
1 (5)
Mainly
Mainly
Mainly
Occasionally
75
100
75
0
11 (85)
9 (69)
9 (69)
0
Yes
Yes
Yes
No
Pneumonology
Paediat rics
Neurology
Int ernal medicine
0
8 (40)
Occasionally
Occasionally
0
50
0
5 (38)
No
No
Family medicine
Gynaecology
10 (50)
9 (45)
6 (30)
0
11 (55)
11 (55)
Mainly
Mainly
Mainly
None
Mainly
Mainly
75
25
0
0
50
0
5 (38)
6 (46)
4 (31)
0
7 (54)
8 (62)
No
No
No
No
No
Yes
Dermat ology
Oncology
Neurology
Family medicine
Neurology
Endocrinology
11 (55)
Mainly
0
8 (62)
Yes
Endocrinology
2 (10)
10 (50)
15 (75)
6 (30)
14 (70)
Occasionally
Mainly
Mainly
Mainly
Mainly
0
0
25
0
25
1 (8)
8 (62)
12 (92)
3 (23)
11 (85)
No
No
Yes
Yes
No
Ot orhinolaryngology
Endocrinology
Family medicine
Family medicine
Int ernal medicine
7 (35)
Mainly
0
4 (31)
Yes
Cardiology
5 (25)
Occasionally
0
4 (31)
No
Gynaecology
Mainly
50
10 (77)
No
Pneumonology
Mainly
Occasionally
0
25
5 (38)
4 (32)
Yes
Yes
Family medicine
Infect ious diseases
11 (55)
Mainly
50
6 (46)
Yes
Gynaecology
13 (65)
12 (60)
Mainly
Mainly
50
25
8 (62)
9 (69)
Yes
No
Digest ive
Urology
15 (75)
Mainly
50
9 (69)
Yes
Cardiology
14 (70)
12 (60)
18 (90)
Mainly
Mainly
Mainly
50
50
100
9 (69)
7 (54)
11 (85)
Yes
Yes
Yes
Cardiology
Paediat rics
Family medicine
15 (75)
8 (40)
7 (35)
(Cont inued on next page)
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Quality of the pharmacotherapeutic recommendations for the integrated care procedures in Andalusia
Table 3.
Number of crit eria met by each int egrat ed care process
(Cont inuat ion)
Processes
All crit eria
(n=20) No. (%)
Acut e aort ic syndrome
(chest pain)
Non-ST elevat ion
acut e coronary
syndrome (NSTACS);
unst able angina and
non-ST elevat ion
myocardial infarct ion
(AI/ NSTEMI)
(chest pain)
Childhood fever
syndrome
Severe ment al disorder
Eat ing disorders
Kidney replacement
t herapy for chronic
kidney disease:
dialysis and kidney
t ransplant
Pulmonary
t hromboembolism
(chest pain)
HIV/ AIDS
8 (40)
Mainly
0
6 (46)
No
Cardiology
18 (90)
Mainly
50
13 (100)
Yes
Cardiology
13 (65)
Mainly
50
8 (62)
Yes
Paediat rics
16 (80)
7 (35)
15 (75)
Mainly
Mainly
Mainly
75
0
100
11 (85)
5 (38)
9 (69)
No
No
No
Psychiat rics
Psychiat rics
Nephrology
12 (60)
Mainly
25
8 (62)
Yes
Cardiology
15 (75)
Mainly
25
11 (85)
Yes
Infect ious diseases
6 (30)
Mainly
25
2 (15)
Yes
Mainly
Mainly
None
Occasionally
50
25
0
0
7 (46)
7 (46)
1 (8)
1 (8)
Yes
No
No
No
Surgical ield
Tonsillect omy/
adenoidect omy
Hip art hroplast y
Colorect al cancer
Cat aract s
Chronic venous
insuficiency
Cholelit hiasis/
cholecyst it is
Broken hip in elderly
pat ient
Abdominal wall hernia
Heart t ransplant
Pancreat ic t ransplant
Hepat ic t ransplant
Lung t ransplant
Other processes
Care for dent al
caries and dent al
inclusions
Care for smokers
Early care
Breast cancer.
Early det ect ion
of breast cancer
Net work of Andalusian
t umour banks
12 (60)
10 (50)
1 (5)
2 (10)
0
Essent ial
crit eria
277
None
Evidence
Exhaust iveness of
level
t he informat ion
deinition, %
(n=13) No. (%)
0
0
Indicat or
deinition
No
10 (50)
Occasionally
75
6 (46)
No
4 (20)
11 (55)
11 (55)
3 (15)
5 (25)
Occasionally
Mainly
Mainly
Occasionally
Occasionally
25
0
0
0
0
2 (15)
9 (46)
9 (69)
2 (15)
9 (69)
No
No
No
No
No
6 (30)
Occasionally
0
5 (38)
No
14 (70)
3 (15)
7 (35)
Mainly
Occasionally
Mainly
50
0
0
9 (69)
2 (15)
5 (38)
Yes
No
No
None
0
AMI indicates acute myocardial infarction; HIV, human immunodeiciency virus.
0
No
Specialt y
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278
Table 4.
Muñoz Cort e RM et al
Percentage of integrated care processes (PAI) that fulil each criterion by ield
Crit eria
Essential criteria
Does it cont ain t reat ment recommendat ions?
Does it cont ain t reat ment recommendat ions
for most examples?
Deining evidence level
Does it indicat e t he level of evidence
for a recommendat ion?
Does it indicat e t he level of evidence for most
recommendat ions?
Does it provide references for any
of it s recommendat ions?
Does it provide references for most
of it s recommendat ions?
Exhaustiveness of the information
Do the recommendations list speciic drugs?
Are guidelines for dosage, administ rat ion frequency and
t reat ment durat ion provided?
Are irst-choice and alternative medications listed?
Are some medications or medication groups speciically
advised against ?
Does it list drugs for speciic patient subgroups or special
clinical sit uat ions? RF LF Pregnancy
Does it specify different t reat ment s for different st at es
of t he same disease?
Is a goal deined in order to evaluate the effectiveness
of t he pharmacot herapy?
Does it deine a follow-up method to check the effectiveness
of a recommended drug?
Are possible adverse reactions deined?
Does it deine methods for preventing, minimising
or communicat ing adverse react ions t o t he drug?
Are drug-drug, drug-food and drug-diagnost ic
t est int eract ions considered?
Does it ment ion non-pharmacological t reat ment alt ernat ives?
Does it deine a pharmacological treatment algorithm?
Indicator deinition
Are indicators deined in order to evaluate proper use
of medicat ions in t he care process?
using common, shared language. As wit h any broad-reaching
management int ervent ion, it was impossible for t his st udy
t o cover all aspect s equally. It is possible t hat formal rigour
in pharmacot herapy recommendat ions was not one of t he
main organisat ional priorit ies in t heir early days. 25
However, t he result s of our st udy show t hat t here is a
need t o review t hese recommendat ions, and as we were
inishing the editing process for this article, such a process
was already being implement ed on an inst it ut ional level by
t he Regional Minist ry of Healt h. 26
Last ly, we believe t hat t he quest ionnaire we prepared for
t his st udy can also be applied t o evaluat ing pharmacot herapy
All PAIs, %
(n=60)
Medical ield, % Surgical ield, %
(n=43)
(n=12)
Other, %
(n=5)
92
70
95
81
83
42
80
40
37
44
25
0
17
23
0
0
47
53
33
20
12
12
8
20
85
78
88
86
83
67
80
60
68
38
77
49
42
17
60
0
33
37
25
20
57
70
17
40
45
56
17
20
42
51
17
20
38
18
42
21
33
17
20
0
28
28
25
20
73
15
74
19
67
8
80
0
45
56
17
20
recommendat ion qualit y in ot her t reat ment guides and
prot ocols in various healt h dist rict s and syst ems.
Acknowledgments
We would like to thank pharmacist Juan Carlos Domínguez from
the Pharmacy Division (Sevilla area) for reviewing and correcting
the text. His ample knowledge of and experience with writing
and evaluating clinical practice guides was a great help to us.
We would also like t o t hank our panel of expert s, t he
specialist s from t he Pharmacy Division at Hospit ales
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Quality of the pharmacotherapeutic recommendations for the integrated care procedures in Andalusia
Table 5.
279
Analysis of the degree of compliance of processes by clinical ield
Clinical ield
Exhaust iveness
Deinition of indicators
of t he informat ion (percent age of processes wit h
(n=13)
indicat ors) a
All
crit eria
(n=20)
Essent ial
crit eria
(n=2)
Evidence level
deinition
(n=4)
Medical processes
Mean
Mean
Int erquart ile range
11.2b
11
7-15
1.8
2
2-2
1.3
1
0-2
6.9
8
4.5-10
56
Surgical processes
Mean
Mean
Int erquart ile range
6.2
5.5
2.6-10
1.3
1
1-2
0.44
0
0-1
4.2
3
1.5-7
17
Ot hers
Mean
Mean
Int erquart ile range
6
6
1.5-6.5
1.2
1
0.5-2
0.4
0
0-0
4.6
5
2-5
20
Tot al
Mean
Mean
Int erquart ile range
9.8
9.5
6-14
1.6
2
1-2
1.5
1
0-1
6.1
7.5
4.5-9
45
There is no reason t o analyse cent ral t endency paramet ers where n=1.
Mean crit eria met compared t o t ot al crit eria (n).
a
b
Universit arios Virgen del Rocío, for t heir dedicat ion.
Wit hout t hem, it would not have been possible t o design
and validat e t he t ool we used t o complet e t he purpose of
t his st udy.
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