Uncorrected Manuscript: Title: Development of A Guideline For The Treatment of Generalized Anxiety Disorder With The

Title: Development of a guideline for the treatment of Generalized Anxiety Disorder with the
ADAPTE method.
Running title: Guideline adaptation for GAD
Downloaded from https://academic.oup.com/intqhc/advance-article-abstract/doi/10.1093/intqhc/mzaa053/5840523 by Beurlingbiblioteket user on 23 May 2020

Authors: María M Hurtado1 CP, PhD, Eva V Nogueras2 MD, PhD, Nazaret Cantero3 MD,
Luis Gálvez4, José M García-Herrera5 MD, José M Morales-Asencio6 BSN, MSc, PhD.
PT
1. Clinical Psychologist. Mental Health Unit, Regional University Hospital, Málaga, Spain.
2. Psychiatrist. Mental Health Unit, Regional University Hospital, Málaga, Spain.
RI
SC
4. Care Physician. Health District Málaga- Guadalhorce, Málaga, Spain.
U
6. Professor. Faculty of Health Sciences. University of Málaga, Málaga, Spain.
Word count for the abstract: 99.

AN
Word count of text (excluding Acknowledgements, abstract, tables/figures and reference list):
M
2821.
D
* Corresponding author:
TE
María M Hurtado
UGC Mental Health, Regional University Hospital, Málaga 29009, Spain.

EC
+34 951952833
E-mail: marienahurtado@gmail.com
RR
CO
N
U
© The Author(s) 2020. Published by Oxford University Press in association with the
International Society for Quality in Health Care. All rights reserved. For permissions, please e-
mail: journals.permissions@oup.com
1
Abstract
Generalised anxiety disorder (GAD) is the most frequent anxiety disorder encountered in

primary care practice. However, there is a suboptimal management by family physicians and
limited shared care with mental health services. Clinical guidelines may improve this
PT
scenario, but their development and implementation remains as a major challenge.
Adaptation methods may address these issues. This study aimed to develop a clinical
RI
guideline for improvement of GAD care in a primary care and mental health service in Spain,
SC
using adaptation methods and users’ involvement. The final version included
recommendations and resources to improve the quality of care with a reasonable
U
methodological effort.
AN
Keywords: Practice guidelines, Guidelines adherence, Generalised anxiety disorder,
Professional practice, Evidence based practice.

M
D
TE
EC
RR
CO
N
U
2
Introduction

Anxiety disorders, as diagnostic category, are some of the most prevalent mental disorders
(1). Generalised anxiety disorder (GAD) is the most common in the group of anxiety
PT
disorders, probably because the DSM criteria for GAD describe anxiety more generally (2).
This condition represents more than 50 % of all anxiety disorders in primary care, with a 12-
RI
month prevalence among adults of 2.9% (3). In health systems that use step care, such as in
SC
Spanish, primary care serves as gateway to the specialised level. It also provide health care
to many cases of common mental disorders such as anxiety or depression.
U
In turn, GAD is associated with physical conditions such as cardiovascular disease (4). In
AN
addition, it causes a significant burden of disability, personal suffering and economic burden
(5).
M
In those countries with a strong primary health care (PHC) system, this is the first point of
D
access to the health system for GAD patients; further, most end up receiving their mental
TE
health services at this level. The detection of GAD at during its early phases is a key factor in
providing effective treatment. Nevertheless, in many cases, there is a significant delay in the
EC
person seeking medical help (6); further, there is a low detection rate (7), Even if detected,
the care provided is quite often suboptimal (8).

RR
One of the ways to deal with this scenario involves the improvement of decision-making
through the implementation of clinical guidelines (CGs). The Institute of Medicine defines
CO
CGs as “statements that include recommendations intended to optimize patient care. They
are informed by a systematic review of evidence and an assessment of the benefits and
N
harms of alternative care options” (9). During the last 20 years, CGs -elaborated rigorously-
U
have become extremely useful instruments for this purpose in health care. Thus, CGs
derived (a) using rigorous and explicit methods; (b) incorporating the best evidence; (c)
developed by a multidisciplinary panel of experts and representatives from key affected
groups (thus incorporating patients’ values and preferences) have the potential to
3
significantly improve the quality of care, by reducing the variability of clinical practice and
facilitating the translation of research into practice (10).
Nevertheless, the implementation and adoption of recommendations in clinical practice

remains as a major challenge (11). Clinicians’ adherence to CGs is a key aspect for
maximising the impact of CGs. The presence of barriers (e.g. lack of knowledge or familiarity
PT
with CGs) may jeopardise this process, compromising the clarity and/or strength of the
recommendations or those derived from the context of practice (11). Knowledge translation
RI
into practice has focused on overcoming barriers for implementation, although less research
SC
has been conducted to examine long-term adherence to recommendations (12). Many
theories and models have been proposed to address this issue. In this regard, the
U
Consolidated Framework for Implementation Research (CFIR) proposes a meta-theoretical
AN
repository of standardised implementation-related constructs, to be applied for the
implementation of CGs (13). In the case of anxiety disorders, the implementation of

M
CGs may improve patient outcomes when practitioners apply CGs recommendations, such
D
as a reduction in the incidence of anxiety symptoms (14,15).

TE
The massive development of CGs during the last 20 years has promoted progress on
methods for its design, adaptation and evaluation. The abundance of CGs has yielded
EC
adaptation as an alternative approach to the development of “ex novo” CGs, by means of
contextualising them in an environment different from the one originally conceived (16).
RR
Producing CGs involves a substantial effort and use of resources, but adaptation methods
permit that this initial endeavour may be applied to different environments, without generating
CO
redundant CGs and optimising efforts (17,18). Moreover, user involvement is a key
component of CGs development and implementation (19). It may empower patients to make
N
more informed health care choices and, overall, support a better decision-making process
U
(20). People who receive mental health care may express satisfaction with services;
however, this is not a guarantee that the best care is being delivered. There still remain
issues for patients in acknowledging they have a mental health problem and seeking help.
They also may fail to build adequate relationships with their health care providers (such as
4
can be developed through participation in their care decisions) or work towards continuity of
care (21). Thus, the combination of adaptation methods with users’ involvement can
contribute to a powerful development of CGs, with a less time-consuming process, facilitate

the translation of knowledge to practise and help generate a more person-centred approach.
In the context of a health care area in Malaga (Spain), with a lengthy tradition (for more than
PT
two decades) involvement in collaborative mental health services, the mental health service,
together with the District of PHC, decided to develop a CG for the improving care for GAD
RI
adult patients being treated at PHC level (through CG-adaptation methods, and incorporating
SC
service users’ testimonies). The aim was to optimise treatment efforts and ensure
methodological accuracy.
U
The aim of this manuscript is to illustrate the process of developing a clinical guideline for
AN
improvement of GAD care in a primary care and mental health service in Spain by using
adaptation methods and users’ involvement.

M
D
Participants and Methods

TE
The CG was developed following guidelines from the ADAPTE group (17,18,22,23), using a
mixed-methods approach. Quantitative methodology was applied in some phases of the

EC
process (e.g. assessment of existing GCs with the AGREE instrument, external review).
Qualitative methods involved focus groups with users to obtain their perspective on domains
RR
included in the CG. This phase was guided according Taylor & Bodgan’s approach to
descriptive qualitative research (24).

CO
The professionals who participated were family physicians from PHC, psychiatrists and
psychologists from the primary health care district of Málaga and the unit of mental health
N
from Málaga regional university hospital, which services a reference population of 165,311
U
individuals. The phases of the process are described in Table 1, and took place from 2013 to
2015. The conclusions obtained during the qualitative phase with users have been integrated
into the recommendations of the CG. The criteria to select these service users were to have
a diagnosis of generalised anxiety disorder, according the DMS-IV (25) by psychiatrists or
5
clinical psychologists and, at least, two appointments for mental health services, in addition
to consultations in PHC, to ensure that they had sufficient experience with different health
care providers.

1. Definition of clinical scenarios.
The objective of this task was to identify which aspects of anxiety disorders generated
PT
uncertainty about their management in our country, especially in PCPs, since most of these
patients are treated at this level. By such means, the GDG could determine which questions
RI
the CG should addresss as a priority.
SC
To identify areas of uncertainty in the management of GAD, we used a framework derived in
a previous work: Clinical Practice Guideline for the treatment of depression in primary care
U
(26,27). Areas contained therein were evaluated by family physicians and psychiatrics for
AN
accetability, appropriateness, and relevance to clinical practice. A modified Delphi process
was used for analysis (26,27). This process was completed with some specific areas for
M
mental health staff, taking into account those suggested by the different CGs evaluated.
D
2. Literature search
TE
Guideline searches were carried out in different data bases, including: National Guidelines
Clearinghouse, CMA InfoBASE, NICE, SIGN, GIN, Institute for Clinical Improvement, NHS
EC
National Library of Guidelines, TRIP Database and Guiasalud. Additional searches were
developed to identify original studies and systematic reviews considering (a) clinical
RR
scenarios not covered by the available CGs and (b) detailed scenarios specifically related to
the Spanish context. These were performed in PubMed, EMBASE, CINHAL, Cochrane
CO
PLUS, Índice Médico Español, and PsycINFO. These scenarios were: epidemiology of GAD
in Spain, frequency of GAD in the Spanish primary health care system, use of quetiapine for
N
GAD and, finally, use of herbal medicines for GAD. A detailed description of the search
U
strategy for these scenarios can be consulted in Appendix 1.
3. Evaluation of the clinic context and the quality of CGs.
In total, seven CGs were selected to be evaluated using the AGREE II tool (28). This
selection was made by the GDG; two criteria were taken into account. The first of these was
6
that the GC should address the issue of GAD or, alternatively, it should treat anxiety
disorders in general, limiting some of its recommendations to GAD-related issues. The other
criterion was that they were not outdated at the time of starting the AGREE II tool evaluation.

The AGREE II tool (22) is an internationally-recognised instrument for assessing the quality
of CG. It consists of 32 items, grouped into six areas, which should be assessed by 4
PT
independent evaluators. In the present study, CGs were independently evaluated by 4
practitioner: two psychiatrists, a clinical psychologist and a primary care physician (PCP) with
RI
special interest in mental health. Subsequently, the average score in each area was
SC
calculated (Table 2).
The CG of the NICE (29) was the one that obtained the highest rating in each section of the
U
instrument AGREE. Consequently, the NICE guideline was designated as the principal
AN
referenc (using the rest as complementary sources on those aspects where NICE´s would
not offer enough coverage).

M
Additionally, we included two recommendations of the NICE guideline (30) for common
D
mental disorder related to the use of questionnaires for GAD.

TE
4. Elaboration of recommendations.
The CG was fully adapted to the model of recommendations established by NICE’s manual
EC
of CGs, so that the main recommendations could be easily identified. Equally, the grading
method used by NICE was the same used for the recommendations. This approach is
RR
adapted from the GRADE system (31); however, there are some differences in (a) appraisal
of the studies´ cost-effectiveness and (b) methods used for the reporting the
CO
recommendations. The combination of the GRADE method used by the original guideline
from NICE and the AGREE instrument to evaluate the quality of the guidelines both provided
N
a complementary approach to the use of cost-effectiveness approach across the CG.

U
Once ADAPTE methods were applied, the grade of adaptation could imply three different
situations. The first was adoption of the recommendation without any modification, as far as
it was clear and applicable to the Spanish clinical practice contexts in PHC. The second
possibility is adaptation of the recommendation. Adaptation could be due to two possible
7
concerns: (a) the Spanish clinical practice context where the recommendation was going to
be put into practice was substantially different or (b) there was no recommendation in the
CGs about the suggested clinical scenario (necessitating to use of complementary

recommendations derived from systematic reviews, as well as recent original studies).
Finally, rejection is also possible, due to difficulties applying and/or adapting it to the Spanish
PT
clinical context. This process was developed reviewing each one of the scenarios, in two
phases. During the first phase, when the GDG proposed the draft recommendations, there
RI
was already a first adaptation taking into account the peculiarities of the Andalusian health
SC
system (for example, the resources for the care to intellectual disability or substance use are
not integrated into the health system). Subsequently, during the external review, some
U
reviewers made additional suggestions. These suggestions were valued by the GDG and, in
AN
some cases, it was decided to adapt or eliminate the recommendation. Table 3 shows the
result of this process.

M
A total of 7 recommendations were adapted, and 3 recommendations were eliminated.
D
Moreover, “ex novo” searches were generated regarding data of GAD frequency in order to
TE
include contextualised epidemiological figures in Spain, screening of GAD in PHC, use of
quetiapine in GAD, and use of herbal remedies in anxiety disorders. These searches were
EC
conducted in order to expand or update these topics from the NICE CG. None of them
involved modifications of the final recommendations.

RR
5. Service user participation.
Service users were invited to participate in a qualitative study based on focus groups (two
CO
groups of users) through semi-structured interviews addressing the following topics: GAD
impact on daily life and relationships; assessment of the professionals involved (primary care
N
and mental health) and the care process; types of approaches offered in the public health
U
care system (both pharmacological and psychological), perceived usefulness, and personal
resources for coping with anxiety. This information was used to identify possible areas of
uncertainty or demand of care not covered by the CG and to reinforce every
recommendation with contextualised testimonies. This additional information was intended to
8
influence the professionals’ predisposition to comply with recommendations, so that every
user experience (easily recognisable and very familiar for the professionals) had an
evidence-based recommendation.

Service users’ information was analysed through a discourse analysis approach. Thus, the
users’ accounts were literally transcribed and subjected to an initial detailed reading and
PT
detection of emerging issues. Following that, they were coded and grouped into categories
and relevant topics. These codes and categories were triangulated among members of the
RI
GDG to obtain an agreed list, where discrepancies were solved by discussion. Later, the list
SC
of categories was matched against the recommendations. This matching was carried out by
the members of the GDG who conducted the qualitative analysis. As a final point, these
U
matchings were distributed to other members of the GDG to contrast and contextualise these
allocations, resolving discrepancies by consensus.
6. External review
AN
M
The CG was sent to a panel of external reviewers, to be subjected to review. The panel was
D
comprised of nine psychiatrists, ten psychologists, eight family physicians, eight nurses
TE
specialized on mental health or primary care, and one pharmacist. All were active
practitioners treating people with GAD in their daily practice, and with knowledge and interest
EC
in the development of CG. They were asked to evaluate understanding, relevance, feasibility,
and potential barriers to acceptance of the recommendations by a 5-point Likert scale for
RR
each of these issues.
7. Implementation toolkit
CO
At the same time, a process for implementing the CG at the PHC of Malaga was designed
prior to the CG dissemination, based on a specific plan with multifaceted interventions. This
N
included: a multiple-professional group to lead the process, in which a methodological

U
advisor was included; identification of specific local external barriers in each centre, with
special emphasis on factors related to the professionals (competence, attitudes, and
motivation for change) and to the context (colleagues influence, patients, representatives,
organization, time, etc.); appointment of local leaders at each health centre; proactive
9
training with real cases from usual practice that could be resolved following the
recommendations of the CG; use of supporting materials (quick consult material, reminders,
etc.); local dissemination in all the centres; inclusion in the annual commissioning framework

agreements of the health centres, linking them to economic incentives, public endorsement
from institutions and scientific societies; consultancy during the process with support and
PT
advice to professionals; detection of areas of improvement in specific local aspects which
could act as barriers, as well as the definition and baseline analysis of indicators for later
RI
audit and feedback to professionals and managers (32).
SC
Internal barriers to implementation were evaluated using the “Guide Line Implementability
Appraisal Tool” in its version 2.0 (33). For this purpose, the CG was appraised independently
U
by two external practitioners (a family physician with special interest in mental health and a
psychiatrist).
AN
M
Results
D
The process resulted in three versions of the Guide: a full CG, a short version, and a brief
TE
version. As a result of the definition of clinical scenarios, the 13 identified uncertainty areas
included scenarios relating to the definition and epidemiological aspects of GAD, assessment
EC
and detection, and treatment decisions in general and specific situations.
Through the adaptation process, a total of 49 recommendations were adapted (in content or
RR
in wording), 47 of which derived from the NICE CG 2011 on GAD. The remaining two came
from the common mental disorder NICE CG 2011. These two recommendations dealt with
CO
identification of the GAD in primary care. The GDG decided to include them due to the
degree of evidence that supported them and, as well, similarities between the Spanish and
N
English primary care services. All the recommendations were adapted accordingly to the
U
GRADE methodology. The distributions of the strength of recommendations is detailed in
Table 4. The whole themes and categories identified during the qualitative analysis were
covered by the CG recommendations.
10
External review yielded the highest values in relevance (mean 4.7; SD 0.6; range 1 to 5),
followed by understanding (mean 4.6, SD 0.9; range 1 to 5), and patients’ acceptance (mean
4.3; SD 0.7; range 1 to 5). The lowest values were obtained in feasibility (mean 3.9, SD 0.8;

range 1 to 5).
The analysis of barriers and facilitators showed issues focused on competence, continuity of
PT
patient care, and availability of time, in the case of the barriers. The main facilitators reported
by reviewers were related to its methodological quality and the institutional commitment with
RI
the CG (Table 5).
SC
The analysis of internal barriers intrinsic to the CG yielded a high consensus on its
executability, decidability, validity, flexibility, effects on process of care, measurability and
U
novelty. Nevertheless, eight recommendations needed more specifications about practice
AN
characteristics (such as location and availability of support services), and four
recommendations were identified as difficult to pilot without a substantial resource

M
commitment.
D
Two indicators were defined for monitoring the implementation process, intended to evaluate
TE
changes in the GAD detection and diagnose, as well as treatment decisions, follow-up and
referral to specialised care. Additionally, a set of self-help brochures and guidance was
EC
elaborated as a supplementary resource for clinicians and patients (Available at:
http://www.juntadeandalucia.es/servicioandaluzdesalud/principal/documentosacc.asp?pagin
RR
a=gr_smental_23_12_gauto_1). The testimonies from the focus groups were linked with 10
recommendations of the CG; these which addressed issues on information about the
CO
disorder, family involvement, diagnosis, low-intensity psychological interventions, and
preference on psychological interventions by users.

N
U
Discussion
The aim of this initiative was to develop a CG for managing GAD in PHC, using adaptation
methods. The result is a set of resources that can contribute to improve the quality and
11
effectiveness of the care provided to these patients with a reasonable methodological effort,
putting into balance rigour and adaptation process.
Along all the process, 45 people (including authors and reviewers) took part. The effort made

means an important impetus for the improving the efficacy of health care provided to people
with GAD in PHC, by the use of adaptation methods, to overcome some of the usual
PT
shortcomings in the systematic application of evidence into clinical practice (34,35). It is
remarkably how some CGs evaluated by the expert panel prior to the selection of guidelines
RI
were rated very low regarding their applicability. This result was explained by the perception
SC
from those local providers who rated these CGs, who considered that the health care
provision where these CGs were developed was very different from the Spanish context.
U
Previous studies have reported improvement of anxiety symptoms when physicians
AN
incorporated evidence-based recommendations into their practice (14,15), invite to be
optimistic about the potential impact of the CG, although in other areas of mental health care,
M
such as schizophrenia, the combination of several guideline dissemination and
D
implementation strategies targeting healthcare professionals did not reduce antipsychotic

TE
use (36).
Although the process of developing and implementing the CG is time-consuming, the use of
EC
adaptation methods releases an important part of this effort, although some experiences
reported that adaptation did not meet expectations for reducing time or resource
RR
commitments, e.g. in the case of cancer care (37). Nonetheless, CG adaptation methods are
being used increasingly in the mental health field (23) and for physical problems such as lung
CO
cancer (17) or back pain (18). Through these methods, high-quality CGs are being
developed more efficiently internationally (17,18,23).

N
On the other hand, the gap existing between the production of evidence and its translation
U
into practice requires clear efforts to close. Facilitation of evidence-based practice is a
multifaceted process and adaptation has been found to be a key element in the knowledge-
translation continuum (37). Additionally, in our case, the involvement of leaders, experts and
end users turned out in an implementation action itself, as currently recommended. Current
12
implementation theories, models, and frameworks should be considered when trying to
develop and/or implement knowledgetranslation interventions (12).
Adaptation methods are not definitive; further, they may require additional resources if no

high-quality CGs are available or uncertainties are not addressed in the existing ones. Thus,
some “de novo” development might be needed for a given area (38). Expert teams should
PT
give support along the whole process to guarantee that rigour in methods is preserved. But,
despite these limitations, adaptation methods offer a way of using resources more efficiently
RI
when developing CGs, thereby avoiding unnecessary replication (16).
SC
It has been shown how the implementation of guidelines and appropriate training for health
care providers facilitate the management of anxiety disorders by GPs (39,40). Thus, adaptive
U
methods allow easily available evidence-based resources to provide GPs with
AN
recommendations on the most appropriate treatment of GAD in each case, including models
of collaborative care (39).

M
The CG has been evaluated for its implementability and a comprehensive range of
D
multifaceted interventions have been deployed to facilitate its implementation (an

TE
experimental study has been defined to assess the final results of this implementation
process). Implementation research is acknowledged as an important component of mental

EC
health services research and as a critical element to translate knowledge into practise (35).
The GDG set out this issue as a strategic component of the CG development to achieve
RR
some of these prerequisites.
The linkage of service users’ perspectives to recommendations using qualitative methods is

CO
a novel approach to methods of user involvement. It contributes to addressing a common
issue concerning the lack of clarity in identifying the impact of users input when participating
N
in guidelines development (41). These initiatives are in line with the literature on guidelines
U
development, which increasingly recommends a greater understanding of end users through
qualitative methods and patient engagement (42).
13
Acknowledgements

The authors are grateful to all reviewers for their help to improve the Clinical Practice
Guidelines for the Treatment of Generalised Anxiety Disorder: Francisco Alcaine Soria,
PT
María José Ariza Conejero, Matilde Blanco Venzalá, Pablo Cano Domínguez, Francisco
Javier Carrascoso López, María Paz Conde Gil de Montes, Carlos Cuevas Yust, María del
RI
Carmen Díaz González, Alfonso Fernández Gálvez, Carlos Fernández Oropesa, Ana Maria
SC
Fernández Pina, Ana Fernández Vargas, Joana Fornés Vives, Bienvenida Gala Fernández,
Luis Gálvez Alcaraz, Pablo García Cubillana, Francisco Javier González Mesa, María José
U
Graván Morales, Antonio Gutiérrez Iglesia, Maria Herrera Usagre, Evelyn Huizing, Juan
AN
Francisco Jiménez Estévez, Mercedes Márquez Castilla, Fermín Mayoral Cleríes, Cristina
Moreno Corona, Berta Moreno Küstner, Francisca Muñoz Cobos, Casta Quemada
M
González, Francisco Rodríguez Pulido, Javier Romero Cuesta, Modesto Ángel Ruiz Moreno,
D
José Manuel Sánchez López, Francisca Sánchez Sánchez, Jesús Sepúlveda Muñoz, Juan
TE
Manuel Téllez Lapeira and José Fernando Venceslá Martínez.

EC
Financial Support: This research received no specific grant from any funding agency,
commercial or not –for -profit sectors.

RR
Conflict of Interest: None.
Ethical Standards:
CO
The authors assert that all procedures contributing to this work comply with the ethical
standards of the relevant national and institutional committees on human experimentation

N
and with the Helsinki Declaration of 1975, as revised in 2008.

U
14
References

1. Baxter AJ, Vos T, Scott KM, Norman RE, Flaxman AD, Blore J, et al. The
PT
regional distribution of anxiety disorders: implications for the Global Burden of
Disease Study, 2010. Int J Methods Psychiatr Res [Internet]. 2014 Dec [cited
RI
2019 Dec 4];23(4):422–38. Available from:
SC
http://www.ncbi.nlm.nih.gov/pubmed/25048296
2. Crocq MA. The history of generalized anxiety disorder as a diagnostic
U
AN
category. Dialogues Clin Neurosci. 2017;19(2):107–16.
3. Kessler RC, Petukhova M, Sampson NA, Zaslavsky AM, Wittchen H-U.

M
Twelve-month and lifetime prevalence and lifetime morbid risk of anxiety and
mood disorders in the United States. Int J Methods Psychiatr Res [Internet].
D
2012 Sep [cited 2019 Dec 4];21(3):169–84. Available from:

TE
EC
4. Latas M, Vučinić Latas D, Spasić Stojaković M. Anxiety disorders and medical
illness comorbidity and treatment implications. Curr Opin Psychiatry. 2019 Sep
RR
1;32(5):429–34.
5. Hendriks SM, Spijker J, Licht CMM, Hardeveld F, de Graaf R, Batelaan NM, et

CO
al. Long-term disability in anxiety disorders. BMC Psychiatry [Internet]. 2016

N
[cited 2019 Dec 4];16:248. Available from:

U
6. Chang S, Abdin E, Shafie S, Sambasivam R, Vaingankar JA, Ma S, et al.
Prevalence and correlates of generalized anxiety disorder in Singapore:
Results from the second Singapore Mental Health Study. J Anxiety Disord
15
[Internet]. 2019 Aug [cited 2019 Dec 4];66:102106. Available from:
7. Piontek K, Shedden-Mora MC, Gladigau M, Kuby A, Löwe B. Diagnosis of

somatoform disorders in primary care: diagnostic agreement, predictors, and
comparisons with depression and anxiety. BMC Psychiatry. 2018 Nov
PT
12;18(1):361.
RI
8. Fernández A, Haro JM, Codony M, Vilagut G, Martínez-Alonso M, Autonell J,
SC
et al. Treatment adequacy of anxiety and depressive disorders: primary versus
specialised care in Spain. J Affect Disord [Internet]. 2006 Nov [cited 2019 Dec
U
4];96(1–2):9–20. Available from:
9.
AN
Guidelines I of M (US) C on S for DTCP, Graham R, Mancher M, Wolman DM,
M
Greenfield S, Steinberg E. Clinical Practice Guidelines We Can Trust. Clinical
D
Practice Guidelines We Can Trust. National Academies Press; 2011.

TE
10. Grimshaw JM, Thomas RE, MacLennan G, Fraser C, Ramsay CR, Vale L, et
al. Effectiveness and efficiency of guideline dissemination and implementation

EC
strategies. Int J Technol Assess Health Care. 2005;21(1):149.

RR
11. Martin GP, Currie G, Finn R, McDonald R. The medium-term sustainability of
organisational innovations in the national health service. Implement Sci

CO
[Internet]. 2011 Mar 14 [cited 2019 Dec 4];6:19. Available from:
N
12. Tricco AC, Ashoor HM, Cardoso R, MacDonald H, Cogo E, Kastner M, et al.
U
Sustainability of knowledge translation interventions in healthcare decision-
making: A scoping review. Implement Sci [Internet]. 2016 Apr 21 [cited 2020
Mar 13];11(1):55. Available from:
16
13. Kirk MA, Kelley C, Yankey N, Birken SA, Abadie B, Damschroder L. A
systematic review of the use of the Consolidated Framework for

Implementation Research [Internet]. Vol. 11, Implementation Science. BioMed
Central Ltd.; 2016 [cited 2020 Mar 13]. p. 72. Available from:
PT
RI
14. Hepner KA, Rowe M, Rost K, Hickey SC, Sherbourne CD, Ford DE, et al. The
SC
effect of adherence to practice guidelines on depression outcomes. Ann Intern
Med. 2007 Sep 4;147(5):320–9.
U
15. van Dijk MK, Oosterbaan DB, Verbraak MJPM, Hoogendoorn AW, Penninx
AN
BWJH, van Balkom AJLM. Effectiveness of the implementation of guidelines
for anxiety disorders in specialized mental health care. Acta Psychiatr Scand
M
[Internet]. 2015 Jul 1 [cited 2020 Mar 7];132(1):69–80. Available from:
D
TE
16. Fervers B, Burgers JS, Haugh MC, Latreille J, Mlika-Cabanne N, Paquet L, et
al. Adaptation of clinical guidelines: Literature review and proposition for a

EC
framework and procedure. Vol. 18, International Journal for Quality in Health
RR
Care. Oxford University Press; 2006. p. 167–76.
17. Chakraborty SP, Jones KM, Mazza D. Adapting lung cancer symptom
CO
investigation and referral guidelines for general practitioners in Australia:
reflections on the utility of the ADAPTE framework. J Eval Clin Pract [Internet].
N
2014 Apr [cited 2019 Dec 4];20(2):129–35. Available from:

U
18. Harstall C, Taenzer P, Zuck N, Angus DK, Moga C, Scott NA. Adapting low
back pain guidelines within a multidisciplinary context: a process evaluation. J
17
Eval Clin Pract [Internet]. 2013 Oct [cited 2019 Dec 4];19(5):773–81. Available
from: http://www.ncbi.nlm.nih.gov/pubmed/22845891
19. Rashid A, Thomas V, Shaw T, Leng G. Patient and Public Involvement in the

Development of Healthcare Guidance: An Overview of Current Methods and
Future Challenges. Patient. 2017 Jun 1;10(3):277–82.
PT
20. Légaré F, Boivin A, van der Weijden T, Pakenham C, Burgers J, Légaré J, et
RI
al. Patient and public involvement in clinical practice guidelines: a knowledge
SC
synthesis of existing programs. Med Decis Making [Internet]. [cited 2019 Dec
4];31(6):E45-74. Available from:
U
21.
AN
Newman D, O’Reilly P, Lee SH, Kennedy C. Mental health service users’
experiences of mental health care: An integrative literature review. J Psychiatr

M
Ment Health Nurs. 2015 Apr 1;22(3):171–82.
D
22. Guideline Adaptation: A Resource Toolkit [Internet]. 2010 [cited 2019 May 3].
TE
Available from: www.adapte.org
23. Andersen BL, DeRubeis RJ, Berman BS, Gruman J, Champion VL, Massie MJ,
EC
et al. Screening, assessment, and care of anxiety and depressive symptoms in

RR
adults with cancer: An American Society of Clinical Oncology guideline
adaptation. Vol. 32, Journal of Clinical Oncology. American Society of Clinical

CO
Oncology; 2014. p. 1605–19.
24. Taylor SJ, Bogdan R, DeVault ML, Preceded by: Taylor SJ. Introduction to
N
qualitative research methods: a guidebook and resource. 401 p.

U
25. Frances A, Pincus H, First M, et al. DSM-IV Diagnostic and Statistical Manual
of Mental Disorders [Internet]. American Psychiatric Association, Washington,
D.C.; 2009 [cited 2019 Dec 5]. 552–464 p.
18
26. Nogueras E V, Hurtado MM, Flordelís E, García-Herrera JM, Morales-Asencio
JM. Use of the ADAPTE Method to Develop a Guideline for the Improvement of
Depression Care in Primary Care. Psychiatr Serv [Internet]. 2017 Aug 1 [cited

2019 Mar 11];68(8):759–61. Available from:
http://psychiatryonline.org/doi/10.1176/appi.ps.201700163
PT
27. García-Herrera Pérez Bryan JM, Nogueras Morillas EV, Muñoz Cobos F MAJ.
RI
Guía de Práctica Clínica para el Tratamiento de la Depresión en Atención
SC
Primaria [Internet]. (Clinical Guideline for the Treatment of Depression in
Primary Care). Grupo para el estudio de la depresión en Atención Primaria,
U
editor. Málaga: Distrito Sanitario Málaga-UGC Salud Mental Hospital Regional
AN
Universitario de Málaga; 2011 [cited 2019 May 3]. Available from:
http://www.juntadeandalucia.es/servicioandaluzdesalud/distritomalaga/docs/sal
M
ud_mental/Guia-depresion-rapida.pdf
D
28. Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, et al.
TE
AGREE II: Advancing guideline development, reporting, and evaluation in
health care. Prev Med (Baltim) [Internet]. 2010 Nov [cited 2019 May
EC
3];51(5):421–4. Available from:

RR
https://linkinghub.elsevier.com/retrieve/pii/S0091743510003087
29. Overview | Generalised anxiety disorder and panic disorder in adults:

CO
management | Guidance | NICE.
30. Overview | Common mental health problems: identification and pathways to

N
care | Guidance | NICE.

U
31. Castillejo MM, Barrientos AM. El sistema GRADE para la toma de decisiones
clínicas y la elaboración de recomendaciones y guías de práctica clínica. (The
GRADE system for clinical decision-making and the development of clinical
19
guidelines and recommendations). Atención Primaria. 2007 Sep 1;39(9):457–
60.
32. Registered Nurses Association of Ontario. Toolkit: Implementation of Best

Practice Guidelines. Second Edition. Registered Nurses Association of Ontario,
editor. Toronto, ON; 2012. 1–154 p.
PT
33. Shiffman RN, Dixon J, Brandt C, Essaihi A, Hsiao A, Michel G, et al. The
RI
GuideLine Implementability Appraisal (GLIA): development of an instrument to
SC
identify obstacles to guideline implementation. BMC Med Inform Decis Mak
[Internet]. 2005 Jul 27 [cited 2019 Dec 4];5:23. Available from:
U
34.
AN
Forsner T, Hansson J, Brommels M, Wistedt AA, Forsell Y. Implementing
clinical guidelines in psychiatry: a qualitative study of perceived facilitators and

M
barriers. BMC Psychiatry [Internet]. 2010 Jan 20 [cited 2019 Dec 4];10:8.
D
Available from: http://www.ncbi.nlm.nih.gov/pubmed/20089141

TE
35. Proctor EK, Landsverk J, Aarons G, Chambers D, Glisson C, Mittman B.
Implementation research in mental health services: An emerging science with

EC
conceptual, methodological, and training challenges. Adm Policy Ment Heal

RR
Ment Heal Serv Res. 2009 Jan;36(1):24–34.
36. Barbui C, Girlanda F, Ay E, Cipriani A, Becker T, Koesters M. Implementation

CO
of treatment guidelines for specialist mental health care ( Review ) SUMMARY
OF FINDINGS FOR THE MAIN COMPARISON. Cochrane database Syst Rev

N
[Internet]. 2014 [cited 2019 Sep 30];12(1):2–4. Available from:

U
http://doi.wiley.com/10.1002/14651858.CD009780.pub3%5Cnhttp://www.ncbi.n
lm.nih.gov/pubmed/27977851
37. Harrison MB, Graham ID, van den Hoek J, Dogherty EJ, Carley ME, Angus V.
20
Guideline adaptation and implementation planning: a prospective observational
study. Implement Sci [Internet]. 2013 May 8 [cited 2019 Dec 4];8:49. Available
from: http://www.ncbi.nlm.nih.gov/pubmed/23656884

38. Fervers B, Burgers JS, Voellinger R, Brouwers M, Browman GP, Graham ID, et
al. Guideline adaptation: An approach to enhance efficiency in guideline
PT
development and improve utilisation. BMJ Qual Saf. 2011;20(3):228–36.
RI
39. Piek E, van der Meer K, Nolen WA. Guideline recommendations for long-term
SC
treatment of depression with antidepressants in primary care--a critical review.
Eur J Gen Pract [Internet]. 2010 Jun [cited 2019 Dec 4];16(2):106–12.
U
Available from: http://www.ncbi.nlm.nih.gov/pubmed/20297924
40.
AN
Sikorski C, Luppa M, König HH, Van Den Bussche H, Riedel-Heller SG. Does
GP training in depression care affect patient outcome? - A systematic review

M
and meta-analysis. Vol. 12, BMC Health Services Research. 2012.
D
41. van der Ham AJ, Shields LS, van der Horst R, Broerse JEW, van Tulder MW.
TE
Facilitators and barriers to service user involvement in mental health
guidelines: lessons from the Netherlands. Adm Policy Ment Health [Internet].
EC
2014 Nov [cited 2019 Dec 4];41(6):712–23. Available from:

RR
42. Armstrong MJ, Rueda JD, Gronseth GS, Mullins CD. Framework for enhancing
CO
clinical practice guidelines through continuous patient engagement. Heal
Expect. 2017 Feb 1;20(1):3–10.

N
U
21
TABLES:

Table 1: Phases of ADAPTE methodology
Tasks Stakeholders
PT
Preparation Preparation of operational A Guideline Development Group
framework for ADAPTE strategy (GDG) comprised of three
RI
(setting up equipment, selection psychiatrists, a clinical
of the CG themes, evaluation of psychologist, and an academic
SC
adaptability, identification and from the University with
planning of resources) expertise on evidence-based
health care, guideline
U
development and
AN
implementation.
Adaptation Definition of queries about For the definition of clinical
health topics (scope, purpose scenarios, two panels were
M
and uncertainty clinical constituted. One of them,
scenarios) constituted by 66 PCPs,
D
proposed and evaluated the

clinical scenarios. Following
TE
that, a new panel comprised of

12 members ( seven PCPs,
three psychiatrists, and two
EC
psychologists) resolved the

discrepancies and refined the
RR
final proposal of clinical

scenarios.
Making of an initial draft GDG
CO
Search for and selections of GDG

CGs
Decision about GDG
N
recommendations
U
Evaluation of CGs A panel consisting of 4

independent reviewers was
formed (two psychiatrists, a
clinical psychologist, and a
PCP).
Final External review The external review panel was
22
composed of 9 psychiatrists, 10
psychologists, 8 PCPs, 8 nurses
specialised in mental health or
primary care, and one

pharmacist. The GC was also
reviewed by 7 national scientific
societies.
PT
Additionally, internal barriers for
its implementation were
evaluated independently by two
RI
external practitioners (a PCP
with special interest in mental
SC
health and a psychiatrist).
Planning updates GDG
U
Final issue of CG GDG
AN
M
Table 2: AGREE scores of the evaluated Clinical Guidelines (CG)
D
CG
CG3(NICE CG
4(NICE, CG CG
CG1(Bal CG Common 6(Canadian
TE
DOMAINS anxiety 5(Ansiedad 7(Bandelo

dwin et 2(Baldwi mental Psychiatric
disorder in en AP, w et al.,
al., 2005) n, 2014) disorders, Association,
adults, 2008) 2013).
2011) 2006)
2011)
EC
Scope and purpose 94% 36% 94% 97% 86% 80% 13%
Stakeholder
43% 4% 75% 93% 58% 39% 8%
involvement
RR
Rigour of
58% 19% 90% 94% 88% 65% 9%
development
Clarity and
68% 33% 89% 89% 87% 72% 54%
CO
presentation
Applicability 11% 11% 80% 83% 52% 0% 0%
Editorial
25% 12% 91% 91% 79% 20% 33%
N
independence
U
23
PT
RI
SC
U
AN
M
Table 3: Adapted and removed recommendations
D
Recommendations with adaptations in their content Removed recommendations

-When working with people with GAD:
 Provide information appropriate to the person’s level of
TE
understanding about the nature of GAD and the range of

treatments available
 If possible, ensure that comprehensive written information
EC
is available in the person’s preferred language and in When assessing or offering an

audio format intervention to people with GAD
 Offer independent interpreters if needed. and a moderate to severe
learning disability or moderate
RR
-Psychoeducational groups for people with GAD should: to severe acquired cognitive
 Be based on CBT principles, have an interactive design impairment, consider consulting
and encourage observational learning with a relevant specialist.
 Include presentations and self-help manuals
CO
 Be conducted by trained practitioners

 Have a ratio of one therapist to about 12 participants
 Usually consist of six weekly sessions, each lasting 2
N
hours.
-CBT for people with GAD should:
U
 Be based on the treatment manuals used in the clinical

trials of CBT for GAD Non-harmful substance use
should not be a contraindication
 Be delivered by trained and competent practitioners
to the treatment of GAD.
 Usually consist of 12–15 weekly sessions (fewer if the
person recovers sooner; more if clinically required), each
lasting 1 hour.
-Applied relaxation for people with GAD should:
 Be based on the treatment manuals used in the clinical
24
trials of applied relaxation for GAD
 Be delivered by trained and competent practitioners
 Usually consist of 12–15 weekly sessions (fewer if the
person recovers sooner; more if clinically required), each
lasting 1 hour.
-If a person with GAD chooses drug treatment, offer a selective

serotonin reuptake inhibitor (SSRI). Consider offering sertraline
first because it is the most cost-effective drug, but note that at the
time of publication sertraline did not have UK marketing
authorisation for this indication.
PT
When treating people with
Informed consent should be obtained and documented. Monitor complex and treatment-
the person carefully for adverse reactions. refractory GAD, inform
-For people aged under 30 who are offered an SSRI or SNRI: them of relevant clinical
RI
 Warn them that these drugs are associated with an research in which they may
increased risk of suicidal thinking and self-harm in a wish to participate,
SC
minority of people under 30 and working within local and
 See them within 1 week of first prescribing and national ethical guidelines at all
 Monitor the risk of suicidal thinking and self-harm weekly times(in United Kingdom).
U
for the first month.
-Review the effectiveness and side effects of the drug every 2–4
AN
weeks during the first 3 months of treatment and every 3 months
thereafter.
M
Table 4: Strength of recommendations (n=57)
D
Strong Strong / Weak Weak Good Practice

TE
level level level Recommendations
In favour 26 6 11 4
EC
Against 2 0 0 0
RR
CO
Table 5: Barriers and facilitators

N
Barriers
U
Lack of training on mental health, limited interest of some professionals on matters related to mental health,
not dealing with frequent problems: organisation, involvement, overdiagnosis, shortage of time and pressure
originated by the health care demand, risk of insufficient broadcasting, lack of support from scientific societies
and consultants, low involvement of Spanish clinicians with the guides and protocol, variability of clinical
practice, professionals who become saturated with information, physical co-morbidity of patients with
depression in PHC and low cooperation between primary care and mental health services.
Facilitators
25
Quality of methods, updating, lack of conflict of interests, very much pointed to primary care; institutional
backing, of a national, regional and local level, from societies; contents and recommendations may be
perceived as friendly, close, and individual; make the guide part of a computerised clinical report; to handle
more frequently depressed patients at primary care.

PT
RI
SC
U
AN
M
D
TE
EC
RR
CO
N
U
26

Uncorrected Manuscript: Title: Development of A Guideline For The Treatment of Generalized Anxiety Disorder With The

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Uncorrected Manuscript: Title: Development of A Guideline For The Treatment of Generalized Anxiety Disorder With The

Uploaded by

Copyright:

Available Formats

Title: Development of a guideline for the treatment of Generalized Anxiety Disorder with the

Running title: Guideline adaptation for GAD

Downloaded from https://academic.oup.com/intqhc/advance-article-abstract/doi/10.1093/intqhc/mzaa053/5840523 by Beurlingbiblioteket user on 23 May 2020

2. Psychiatrist. Mental Health Unit, Regional University Hospital, Málaga, Spain.

5. Psychiatrist. Mental Health Unit, Regional University Hospital, Málaga, Spain.

Word count for the abstract: 99.

UGC Mental Health, Regional University Hospital, Málaga 29009, Spain.

Downloaded from https://academic.oup.com/intqhc/advance-article-abstract/doi/10.1093/intqhc/mzaa053/5840523 by Beurlingbiblioteket user on 23 May 2020

recommendations and resources to improve the quality of care with a reasonable

Professional practice, Evidence based practice.

Downloaded from https://academic.oup.com/intqhc/advance-article-abstract/doi/10.1093/intqhc/mzaa053/5840523 by Beurlingbiblioteket user on 23 May 2020

to many cases of common mental disorders such as anxiety or depression.

the care provided is quite often suboptimal (8).

developed by a multidisciplinary panel of experts and representatives from key affected

facilitating the translation of research into practice (10).

Nevertheless, the implementation and adoption of recommendations in clinical practice

Downloaded from https://academic.oup.com/intqhc/advance-article-abstract/doi/10.1093/intqhc/mzaa053/5840523 by Beurlingbiblioteket user on 23 May 2020

implementation of CGs (13). In the case of anxiety disorders, the implementation of

as a reduction in the incidence of anxiety symptoms (14,15).

adaptation as an alternative approach to the development of “ex novo” CGs, by means of

contribute to a powerful development of CGs, with a less time-consuming process, facilitate

Downloaded from https://academic.oup.com/intqhc/advance-article-abstract/doi/10.1093/intqhc/mzaa053/5840523 by Beurlingbiblioteket user on 23 May 2020

adaptation methods and users’ involvement.

Participants and Methods

mixed-methods approach. Quantitative methodology was applied in some phases of the

descriptive qualitative research (24).

a diagnosis of generalised anxiety disorder, according the DMS-IV (25) by psychiatrists or

Downloaded from https://academic.oup.com/intqhc/advance-article-abstract/doi/10.1093/intqhc/mzaa053/5840523 by Beurlingbiblioteket user on 23 May 2020

strategy for these scenarios can be consulted in Appendix 1.

3. Evaluation of the clinic context and the quality of CGs.

Downloaded from https://academic.oup.com/intqhc/advance-article-abstract/doi/10.1093/intqhc/mzaa053/5840523 by Beurlingbiblioteket user on 23 May 2020

not offer enough coverage).

mental disorder related to the use of questionnaires for GAD.

a complementary approach to the use of cost-effectiveness approach across the CG.

possibility is adaptation of the recommendation. Adaptation could be due to two possible

CGs about the suggested clinical scenario (necessitating to use of complementary

Downloaded from https://academic.oup.com/intqhc/advance-article-abstract/doi/10.1093/intqhc/mzaa053/5840523 by Beurlingbiblioteket user on 23 May 2020

result of this process.

include contextualised epidemiological figures in Spain, screening of GAD in PHC, use of

involved modifications of the final recommendations.

5. Service user participation.

uncertainty or demand of care not covered by the CG and to reinforce every

recommendation with contextualised testimonies. This additional information was intended to

Downloaded from https://academic.oup.com/intqhc/advance-article-abstract/doi/10.1093/intqhc/mzaa053/5840523 by Beurlingbiblioteket user on 23 May 2020

allocations, resolving discrepancies by consensus.

each of these issues.

included: a multiple-professional group to lead the process, in which a methodological

special emphasis on factors related to the professionals (competence, attitudes, and

Downloaded from https://academic.oup.com/intqhc/advance-article-abstract/doi/10.1093/intqhc/mzaa053/5840523 by Beurlingbiblioteket user on 23 May 2020

and detection, and treatment decisions in general and specific situations.

GRADE methodology. The distributions of the strength of recommendations is detailed in

covered by the CG recommendations.

Downloaded from https://academic.oup.com/intqhc/advance-article-abstract/doi/10.1093/intqhc/mzaa053/5840523 by Beurlingbiblioteket user on 23 May 2020

executability, decidability, validity, flexibility, effects on process of care, measurability and

recommendations were identified as difficult to pilot without a substantial resource

elaborated as a supplementary resource for clinicians and patients (Available at:

disorder, family involvement, diagnosis, low-intensity psychological interventions, and

preference on psychological interventions by users.

putting into balance rigour and adaptation process.

Downloaded from https://academic.oup.com/intqhc/advance-article-abstract/doi/10.1093/intqhc/mzaa053/5840523 by Beurlingbiblioteket user on 23 May 2020

implementation strategies targeting healthcare professionals did not reduce antipsychotic

developed more efficiently internationally (17,18,23).

into practice requires clear efforts to close. Facilitation of evidence-based practice is a