Open access Original research Proposal of a clinical care pathway for quality and safe management of headache patients: a consensus study report Julio Pascual,1,2 Patricia Pozo-­Rosich ‍ ‍,3,4 Irene Carrillo ‍ ‍,5,6 Sandra Rodríguez-­Justo,7 Dolores Jiménez-­Hernández ‍ ‍,8,9 Almudena Layos-­Romero ‍ ‍,10 Cristina Bailón-­Santamaría,1 Antonio Torres,11 Alba Martínez-­García,6 Emilio Ignacio,12 José Joaquín Mira ‍ ‍6,13 To cite: Pascual J, Pozo-­ ABSTRACT Rosich P, Carrillo I, et al. Strengths and limitations of this study Background Headache is one of the most prevalent Proposal of a clinical care and disabling conditions. Its optimal management pathway for quality and safe ►► The consensus conference is an appropriate meth- requires a coordinated and comprehensive response by management of headache odology to gather expert knowledge on a specific health systems, but there is still a wide variability that patients: a consensus topic. In this study, 28 experts from different health study report. BMJ Open compromises the quality and safety of the care process. services in Spain participated in the design of the 2020;10:e037190. doi:10.1136/ Purpose To establish the basis for designing a care headache care pathway. bmjopen-2020-037190 pathway for headache patients through identifying key ►► To our knowledge, this is one of the first studies to subpathways in the care process and setting out quality provide a detailed description of the headache care ►► Prepublication history and and clinical safety standards that contribute to providing pathway with the integration of the different levels of additional material for this paper are available online. To comprehensive, adequate and safe healthcare. care under a national health system model. view these files, please visit Method A qualitative research study based on the ►► The headache care pathway has been designed the journal online (http://​dx.​doi.​ consensus conference technique. Eleven professionals within the framework of the Spanish national health org/​10.​1136/​bmjopen-​2020-​ from the Spanish National Health System participated, system, limiting its generalisation to other health 037190). seven of them with clinical experience in headache and contexts with different organisational models. four specialists in healthcare management and quality. ►► It was not possible to incorporate the specialty of Received 23 January 2020 First, identification of the key subpathways in the care Revised 15 July 2020 pharmacy in the development of the study. process for headache, barriers/limitations for optimal Accepted 30 September 2020 quality of care, and quality and safety standards applied in each subpathway. Second, two consecutive consensus rounds were carried out to assess the content of the INTRODUCTION subpathway level descriptors, until the expert agreement Headache, besides being one of the most was reached. Third, findings were assessed by 17 external prevalent pathologies, generates a high healthcare professionals to determine their understanding, demand for care that makes it one of the most adequacy and usefulness. Results Seven key subpathways were identified: common reasons for consultation in primary (1) primary care, (2) emergency department, (3) care (PC) and neurology.1 2 This condition neurology department, (4) specialised headache unit, (5) constitutes one of the most disabling health hospitalisation, (6) outpatients and (7) governance and problems and supposes, for those who suffer management. Sixty-­seventh barriers were identified, the from it, a significant socioeconomic impact, most frequent being related to diagnostic errors (36,1%), secondary to both the direct and indirect resource deficiency (25%), treatment errors (19,4%), lack costs of the illness, given that, in many cases, of health literacy (13,9%) and inadequate communications it involves absence from work during the most with care transitions (5,6%). Fifty-­nine quality and 31 © Author(s) (or their safety standards were defined. They were related to productive years of a person’s life.2 3 employer(s)) 2020. Re-­use This impact of this neurological pathology permitted under CC BY-­NC. No evaluation (23.3%), patient safety (21.1%), comprehensive commercial re-­use. See rights care (12.2%), treatment (12.2%), clinical practice necessitates an effective and coordinated and permissions. Published by guidelines (7.8%), counselling (6.7%), training (4.4%) and response by healthcare mechanisms.4 5 Thus, BMJ. patient satisfaction (3.3%). diagnostic criteria and treatment guidelines For numbered affiliations see Conclusions This proposal incorporates a set of have been established,6 response protocols end of article. indicators and standards, which can be used to define a at different levels of care,7 8 care pathways9 10 pathway for headache patients and determine the levels Correspondence to and the quality of headache treatment has of quality. Irene Carrillo; ​icarrillo@​umh.​es been evaluated.11 Despite this, there is high Pascual J, et al. BMJ Open 2020;10:e037190. doi:10.1136/bmjopen-2020-037190 1 Open access variability between countries and health systems in the well as selecting external experts for the final evaluation organisation and design of the care process. of the content. Headache is a pathology that is usually underestimated, A total of 11 professionals participated in the consensus which has had a negative impact on the quality of care conference, seven of them with clinical experience in patients are given, which is sometimes suboptimal.1 This headache patient care (four neurologists, an emer- poor result is due, in part, to the problems of organisa- gency/PC physician, a health manager and a nurse), and tion and coordination between the different levels of four specialists in healthcare management and quality, care involved in the diagnosis and treatment of these including the management of qualitative techniques. patients.10 This first phase of the study was based on the identifica- The quality of care is also affected by the introduction tion and consensus of the key subpathways in the care of new classifications and the existence of a multitude of process for headache patients and on the graphical repre- conditioning situations, such as a large number of head- sentation of possible care flows. ache types, the abuse of self-­medication, the complexity In the first phase, different issues were addressed in a of the symptoms or the comorbidities associated with this face-­to-­face session led by a moderator, in which the indi- medical condition.2 vidual contributions of the participants and other inputs In PC, where most of the patients with headache derived from an open debate were compiled. The issues initially attend, barriers to patient quality and safety have raised in this meeting focused on the subpathways and been detected, including underdiagnosis, the omission elements of the care pathway related to quality and clin- of referrals when called for by the patient’s diagnostic ical safety in the care of headache patients. As a result of and therapeutic complexity, diagnostic and therapeutic this session, the first draft of level descriptors was prepared errors and delays in the start of preventive treatments.1 10 for each of the subpathways previously identified from There has been an attempt to improve the quality of care the consultation of specialised sources and group work. of these patients in the emergency department through The structure of the subpathway level descriptors was referral protocols.10 On the other hand, errors are also composed of the following categories of information: detected in the assessment and diagnosis of headache (1) description of the subprocess, (2) professionals patients in hospitals that hinder the success of thera- involved, who intervenes? (3) activities of the subprocess peutic interventions.12 (what activities or interventions are contemplated?), (4) In this context, the research question that guided this barriers to quality and safety, common pitfalls and errors, study was how headache patient care can be systematically (5) standards for adequate and safe care (with the spec- organised to reduce unnecessary variability and ensure ification of criteria, standards, and sources of informa- the quality and safety of the care process. Accordingly, tion) (table 1). In this session, as well as identifying the the purpose of the study was to establish the basis for subpathways, a first draft of the graphic representation of designing a care pathway for headache patients through the possible attention flows was agreed on. identifying key subpathway in the care process and setting The second phase of the study was carried out through out quality and clinical safety standards that contribute to online systems to facilitate debate and consensus-­building providing comprehensive, adequate and safe healthcare. among experts. In this phase, two consecutive consensus rounds were carried out to assess the content of the subpathway level descriptors and the flow chart, until the agreement was reached between the experts on the METHODS management team. Once the consensus rounds were A qualitative research study based on the consensus over, the team members made a selection of professionals conference technique among professional experts. This from their specialty to be invited to participate in the technique consisted in conducting a scientific conference study, contributing their assessment, opinion and expe- with experts to develop recommendations to address rience as members of a panel of experts. This panel was problems related to clinical practice. Among the main made up of 22 professionals (nine neurologists, three PC advantages of this technique is its adequate performance physicians, five physicians specialised in family medicine, with heterogeneous groups, which allows very diverse but assigned to emergency departments, and five health perspectives in multidisciplinary work to be obtained, managers from different regions and health services in and its ability to promote consensus among participating Spain). experts.13 14 The study period was between February and The panel of experts took part in the final phase September 2019. Figure 1 describes the phases of the of external evaluation for the improvement of the study. subpathway level descriptors prepared, assessing the First, a study management team was formed made up of degree of suitability of the subpathways and their representatives of all the specialties involved in the head- elements, to what extent the barriers identified ache patient care process. The management team was prevented safe and quality care from being carried out to responsible for selecting the benchmark clinical practice the headache patient, as well as the degree of suitability guidelines, the relevant sources of information, and for of the standards for adequate and safe care. Further- defining and validating quality and safety standards, as more, they assessed the contents of these subpathway 2 Pascual J, et al. BMJ Open 2020;10:e037190. doi:10.1136/bmjopen-2020-037190 Open access Figure 1 Main phases of the study. level descriptors in terms of understanding, adequacy professional specialty. Once the evaluation phase was and practical usefulness of the information, using a finalised and the contributions made by this panel were numerical scale from 0 to 10 points. Each panel expert incorporated, the final version of the descriptive cards exclusively valued those subpathways related to their and the flow chart was completed. Table 1 Definition of descriptive categories of information for each subpathway Category of information Definition Subpathway The thread that brings together relevant elements and specific purpose integrated into the care pathway of the headache patient. Description Features of the corresponding subpathway. Who intervenes Professionals responsible for the subpathway described. What activities or interventions are contemplated Statement of the relevant functions and actions in the course of the subpathway for the care of the headache patient. Barriers to quality and safety, common pitfalls and Difficulties and potential quality or safety problems that may hinder the errors proper fulfilment of a subpathway. Pascual J, et al. BMJ Open 2020;10:e037190. doi:10.1136/bmjopen-2020-037190 3 Open access Table 2 Professionals and key activities in the different subpathways of the headache patient care process # Subpathway Person(s) involved Activities 1 PC PC, GP and nursing staff Diagnosis (differential and request for tests), therapeutic approach, (follow-­up) health education, monitoring and possible referral to ND or ED. 2 ED EP Triage, initial assessment (history and examination), possible complementary tests, and referral to PC, ND or SHU. Patients admitted to the emergency observation unit under duty doctor when there is no neurologist on call. 3 ND Neurologist Headache diagnosis (history, physical and neurological examination), differential diagnosis (request for complementary tests), prescription of hygienic-­dietary measures, pharmacological treatment, delivery of headache diary, health education, identification of headache-­related disability (MIDAS and HIT-6 scales), coordination with PC and ED and referral to SHU for advanced therapies. 4 SHU Neurologist Request for additional tests (laboratory and imaging), diagnosis (history and examination), treatment, follow-­up, possible indication of hospital admission, referral to DH, ND or others and discharge to PC. 5 Hospitalisation Neurologist and nursing Differential diagnosis, specific diagnostic tests, therapeutic staff approach, treatment of the underlying process (secondary headaches) and referral to ND or PC for follow-­up. 6 Outpatients Neurologist and nursing Diagnostic and therapeutic approach (lumbar puncture, parenteral staff treatment). 7 Governance and Administrators, senior and Guarantee the availability of the necessary means for adequate management middle management care, the appropriate professional competencies of the personnel involved, and the ongoing evaluation of the structure, processes and outcomes to ensure comprehensive, coordinated and accessible healthcare for the headache patient. DH, day hospital; ED, emergency department; EP, emergency physician; GP, general practitioner; HIT-6, six-­item headache impact text; MIDAS, migraine disability assessment scale; ND, neurology department; PC, primary care; SHU, specialised headache unit. Patient and public involvement Barriers to quality and clinical safety Patients or the public were not involved in any phase of For the first six subpathways identified in the headache this study. patient care process, a total of 67 barriers/limitations were identified that, according to experts, prevented or hindered the provision of safe and quality care (table 3). The subpathway in which the greatest number RESULTS of barriers were concentrated was number 3, corre- Key subpathways in the care pathway for headache patients sponding to the general consultation of the department Seven key subpathways were identified in the process of neurology (20.9% related to diagnosis—3A and 19.4% of comprehensive headache patient care: (1) PC, (2) to treatment—3B). emergency department, (3) neurology department, (4) The barriers present in a greater number of subpath- specialised headache unit, (5) hospitalisation, (6) outpa- ways of the headache patient care process were classified tients and (7) governance and management (table 2). into five categories: diagnostic errors (36.1%), resource The integration of these seven subpathways in the deficiency (25%), treatment errors (19.4%), lack of care pathway is represented in the flow chart shown in health literacy (13.9%), and inadequate communications figure 2. This diagram does not represent the path that all with care transitions (5.6%) (table 4). headache patients necessarily follow, but tries to capture all the possibilities and casuistry of care. Therefore, the Criteria and standards for adequate and safe care full descriptive cards for each subpathway are available in A total of 59 quality and 31 safety criteria and standards the online supplemental material. Subpathway 3, which were defined. The standards were related to evaluation is referred to as the department of neurology (general (21, 23.3%), patient safety (19, 21.1%), comprehensive consultation), was subdivided into two descriptive cards, care (11, 12.2%), treatment (11, 12.2%), compliance one corresponding to the diagnostic process (3A) and the with clinical practice guidelines (7, 7.8%), counselling (6, other to the treatment process (3B), for greater clarity of 6.7%), training (4, 4.4%), patient satisfaction (3, 3.3%) information. and others (8, 8.9%). 4 Pascual J, et al. BMJ Open 2020;10:e037190. doi:10.1136/bmjopen-2020-037190 Open access Figure 2 Descriptive flow chart of the care pathway for the headache patient figure 2Note: Dotted arrows indicate referral paths to other levels of care. The red bidirectional arrows indicate that the referral path can be used in both directions. Evaluation of content by the panel of external experts by the team itself (response rate of 77.3%). Table 5 shows Seventeen professionals not belonging to the project the results of this evaluation. team participated in the external evaluation process of Generally speaking, experts positively evaluated the the subpathway level descriptors and contents developed contents of the subpathway level descriptors drawn up with Table 3 Barriers to quality and safety and common pitfalls and errors in six of the seven subpathways of the headache patient care process No of barriers identified in each subpathway Subpathway 1. Primary care. Identification, therapeutic approach and possible referral 11 Subpathway 2. Emergency department. Triage, assessment, treatment and referral to primary 9 care or neurology department (general or specialised headache unit) or admission in hospital Subpathway 3. Neurology Department (general consultations). 14 A. Diagnostic and therapeutic approach of the headache patient in general neurology consultations B. Identification, therapeutic approach and possible referral in the neurology department, 13 general neurologist to headache neurologist Subpathway 4. Consultation in specialised headache unit. Request for complimentary tests, 8 diagnosis, treatment, follow-­up and possible hospital admission or referral to day hospital, neurology department or primary care Subpathway 5. Hospitalisation. Identification, therapeutic approach during hospitalisation 8 Subpathway 6. Therapeutic approach in day hospital/outpatients 4 A and B represent closely related elements of subpathway 3 (general consultation in the neurology department). The separation of these elements has been done with the only purpose of differentiating the barriers that hinder the correct diagnosis of headache (A) from those that affect the adequate therapeutic approach (B). Pascual J, et al. BMJ Open 2020;10:e037190. doi:10.1136/bmjopen-2020-037190 5 Open access Table 4 Most relevant barriers to achieving optimal care quality N Subpathways in which it is present Diagnostic errors 13  Barrier 1. Excessive complementary tests 5 2, 3A, 3B, 4, 5  Barrier 2. Diagnostic errors 4 1, 3A, 3B, 4  Barrier 3. Underdiagnosis and omission of timely referral 4 1, 3A, 3B, 4 Resource deficiency 9  Barrier 6. Excessive delay in care 3 3A, 3B, 4  Barrier 7. Lack of physical resources 2 3A, 3B  Barrier 8. Short time per visit 2 3A, 3B  Barrier 9. Unavailability of day hospitals 2 4 to 6 Treatment errors 7  Barrier 4. Medication errors (abuse or inappropriate prescription) 5 1, 2, 3B, 4, 5  Barrier 5. Non-­use or improper use of reference guidelines 2 3A, 3B Lack of health literacy 5  Barrier 10. Poor health education of patients 3 1, 3A, 5  Barrier 11. Non-­delivery of documentation on patient treatment 2 3A, 3B Inadequate communication with care transitions 2  Barrier 12. Inadequate referral 2 1 to 2 N, number of times experts pointed out this barrier as limiting the quality of care. an average value of at least eight points in each of the evalu- DISCUSSION ation categories (understanding, adequacy and usefulness). Analysing the pathway followed by the headache patient The best-­rated subpathways were in this order: management, in the course of the healthcare they receive, considering consultation in specialised headache units and emergencies. all the options and the differences in the complexity of Likewise, those considered most useful for their practical their clinical situation, makes it possible to address the application were those related to management, emergency evaluation and improvement of healthcare quality and and PC. According to neurologists, the main focus was to patient safety. This study is framed within this line of work improve the practical usefulness of the content related to initiated by the Global Campaign against Headache5 the treatment process in general neurology (subpathway 3.2) conducted by lifting the burden (LTB) in direct contact whose score did not reach 7 points. with WHO. Table 5 External evaluation of the level descriptors for each subpathway identified in the headache patient care process Understanding the Adequacy of the information information Usefulness Subpathway N Mean (SD) CV Mean (SD) CV Mean (SD) CV 1.Primary care 3 8.0 (0.8) 0.1 8.0 (0.0) 0.0 8.7 (0.0) 0.0 2.Emergency department 5 8.6 (1.4) 0.2 9.2 (0.7) 0.1 8.8 (1.2) 0.1 3A. General neurology (diagnosis) 4 8.5 (1.5) 0.2 8.5 (1.1) 0.1 8.3 (2.0) 0.2 3B. General neurology (treatment) 4 7.0 (1.7) 0.2 7.8 (1.5) 0.2 6.5 (2.1) 0.3 4.Specialised headache unit 3 9.0 (0.8) 0.1 9.0 (0.8) 0.1 8.0 (1.6) 0.2 5.Hospitalisation 4 8.0 (1.6) 0.2 7.5 (2.1) 0.3 7.0 (1.9) 0.3 6 .Day hospital/outpatients 4 8.8 (0.8) 0.1 8.5 (1.1) 0.1 7.5 (1.8) 0.2 7.Management 5 9.0 (0.0) 0.0 9.0 (0.0) 0.0 8.8 (0.4) 0.0 Total 17 8.4 (1.4) 0.2 8.5 (1.3) 0.2 8.0 (1.8) 0.2 CV, coefficient of variation. 6 Pascual J, et al. BMJ Open 2020;10:e037190. doi:10.1136/bmjopen-2020-037190 Open access In the framework of this worldwide project, LTB in barriers and define those criteria and standards necessary collaboration with the European Headache Federation to achieve adequate and safe care. For the six healthcare promoted the creation of a service quality evaluation subpathways, the panel of experts and reviewers identi- (SQE) group of health services researchers and head- fied a total of 67 barriers that in their opinion prevent, or ache specialists. This team of professionals developed a at least hinder, safe and quality care. The barriers identi- set of 30 indicators organised in nine domains to assess fied as most frequent were concentrated in the Neurology the quality of headache services15 that has been validated Department’s subpathway and were related to diagnostic in 12 European countries16–18 Recently, Steiner et al19 errors and resource deficiency. This suggests that the have continued this initiative by defining the 10 roles implementation of the recommendations of the guide- that headache centres play within broader and more lines for headache treatment should be reinforced.6 It structured services and 10 performance standards. These is striking that these results indicate that a high number studies already provide a set of validated indicators to of medication errors (abuse or inappropriate prescrip- detect and rectify deficiencies in the care of headache tion), an excess of complementary tests, and diagnostic patients, focusing on the level of specialised care. errors continue to occur. Other studies support this This study aimed to integrate the different pathways data. For example, in Spain less than 20% of migraine and levels of care that coexist in the management of patients receive the prescription of a triptan (of choice in headache patients following the work initiated by other the symptomatic treatment of moderate-­intense crises), authors.5 15–19 The analysis of barriers and quality stan- ergotics and opioids are still prescribed to a significant dards was carried out considering the whole pathway, number of patients although we know that they induce followed by the patients. headache chronicity and there is an underuse of preven- Health professionals, from different specialties, who tive treatment.20 As for diagnostic barriers, and prob- participated in this study agreed to identify seven key ably due to an excessively sharp interpretation of the subpathways in the care process of headache patients: PC diagnostic criteria of the different primary headaches, consultations, emergency department, neurology depart- the classification of the different headaches remains a ment consultations, specialised headache unit consul- problem for primary headaches, which is undoubtedly tations, hospitalisation and day hospitals/outpatients, one of the causes that justify the excess of diagnostic tests, to which a final category related to administration and also identified as a barrier.21 22 The results of this study, management has been added. These subpathways are in which identify the main barriers in the care pathway for line with the organisational proposals of care for head- headache patients, could help to introduce the necessary ache patients.7 The experience of the experts and the organisational modifications to achieve optimal quality enormous coincidence with the rest of the health profes- of care following the standards that the European scien- sionals involved in this study, coming from the different tific literature has indicated as appropriate.5 15–19 The levels of care and management involved in providing care implementation of these organisational measures could in the ‘headache’ process, have allowed us to establish a be facilitated by conducting a shared reflection involving broad consensus on these findings. all stakeholders in the headache care pathway, including The comparative analysis between the indicators patient representatives. defined in the Global Campaign against Headache15 and There are several reasons to try, as we propose in this those in our proposal indicates a high level of agreement, work, to establish a care pathway for the headache patient although each model has its particularities. First, the process. Headache is, by far, the main cause of neurolog- international proposal offers a global and broad vision ical consultation by frequency, at different levels of care of the determinants involved in the quality of specialised (PC, neurology and emergency department).2 23–25 The headache care, while our study structures the set of indi- demonstration of the efficacy of botulinum toxin type A cators according to the subpathways of the care process. in patients with pathology as frequent and disabling as Second, our proposal delves into the domains C (appro- chronic migraine undoubtedly makes a better organisa- priate referral pathways) and I (safety of care) proposed tion of headache consultations in neurology departments by Peters et al15 and does not contemplate others such necessary.26 27 Finally, the advent of new therapeutic as that referred to the convenience and comfort of the options, such as calcitonin gene-­related peptide antago- centre. Third, our study provides more specific indicators nists28 or various neuromodulation devices,29 which cost regarding treatments (opioids, triptans, oxygen therapy, more than the current options, will force us to further etc) and patient profiles. Finally, we also include other optimise care for headache patients, especially at the level aspects not covered by the SQE such as telemedicine, of hospital neurology departments. overuse or inadequate use of diagnostic tests, and gover- This work also defined a large panel of 59 quality and nance and management indicators. In summary, both 31 safety indicators in the process of headache patients. proposals present elements in common and differ in At a time like the present, in which the efficiency and others that enrich each of the approaches making them sustainability of the healthcare system must prevail in complementary. the management of healthcare processes, and therefore, In this study, we not only identify the main subpath- the health outcomes for patients, we believe that these ways of the headache process, but we study their potential results can serve as a basis when it comes to planning and Pascual J, et al. BMJ Open 2020;10:e037190. doi:10.1136/bmjopen-2020-037190 7 Open access 10 evaluating the ‘headache’ process at different levels of Headache Unit, Neurology Department, University Hospital of Albacete, Albacete, care, something that seems necessary in the immediate Castile-­La Mancha, Spain 11 Andalusian Agency for Healthcare Quality, Seville, Andalusia, Spain future. 12 Department of Nursing and Physiotherapy, University of Cadiz, Cadiz, Andalusia, Spain Limitations 13 Alicante-­Sant Joan Health District, Alicante, Valencia Region, Spain This study was developed within the framework of the Spanish health system, so experiences in headache care Acknowledgements The authors thank the involvement in the study of the may differ in other countries. The health structure and PROMETEO173 Research Group (Generalitat Valenciana, 2017). the organisational model of PC condition the identifi- Contributors JJM and EI conceived and designed the work. AM-­G and IC provided cation of subpathways and barriers so that their gener- methodological support in the conduct of the qualitative techniques. JP, PP-­R, SR-­J, DJ-­H, AL-­R, CB-­S and AT were responsible for providing the information for alisation to other health models should be carried out the elaboration of the headache pathway and recruiting external professionals with caution. For example, not all countries have special- for the evaluation of the subpathways' cards. EI, JJM, IC and AM-­G analysed and ised headache units, and the role that nursing plays in interpreted the data. IC and AM-­G wrote a draft of the manuscript, which was health education and the mobilisation of patients to cope critically reviewed for important intellectual content by JJM. All authors reviewed the draft and approved the final version of the manuscript. EI and JJM took with the illness is quite different. It is possible that the responsibility for the integrity of the work as a whole, from inception to the finished proposal presented can be easily adapted in countries article. with a national health system as in Spain, while it cannot Funding This study was carried out with non-­restrictive funding from Novartis be extrapolated to countries with another care model. (grant number: 1809060787). Furthermore, the non-­ participation of patients in the Disclaimer The need for ethics approval for this research does not apply according design of the pathway is also a significant limitation of the to Spanish regulations. study. The care pathway described, developed under the Competing interests This study has been sponsored by Novartis, but no premise of an integrated approach, should incorporate laboratory professional has been involved in the design of the work, recruitment of the patient’s perspective to ensure person-­centred care. professionals, data collection and analysis, or in the interpretation of the results. The authors of the paper have developed the entire process of execution of the In this study, we tried to minimise this bias by involving study independently. professionals with extensive experience in the manage- Patient consent for publication Not required. ment and care of patients who could provide information on the experience and perspective of patients. Provenance and peer review Not commissioned; externally peer reviewed. Data availability statement All data relevant to the study are included in the Conclusions article or uploaded as online supplemental information. Data are available on reasonable request. The design of the headache care pathway that is proposed as a result of this study advises establishing seven key Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been moments or subpathways in healthcare provision. This peer-­reviewed. Any opinions or recommendations discussed are solely those design should consider the barriers that currently occur of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and and prevent optimal quality and anticipate their limita- responsibility arising from any reliance placed on the content. Where the content tions in providing high-­quality care to this patient profile. includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, In this regard, the experts who have participated in the terminology, drug names and drug dosages), and is not responsible for any error group work came to agree that, although there are refer- and/or omissions arising from translation and adaptation or otherwise. ence guidelines, they are not always used in a practical Open access This is an open access article distributed in accordance with the sense for very different reasons, ranging from budgetary to Creative Commons Attribution Non Commercial (CC BY-­NC 4.0) license, which organisational issues. Finally, this proposal incorporates a permits others to distribute, remix, adapt, build upon this work non-­commercially, and license their derivative works on different terms, provided the original work is set of quality indicators for each of the subpathways, with properly cited, appropriate credit is given, any changes made indicated, and the use their recommended standards, which would allow profes- is non-­commercial. See: http://​creativecommons.​org/​licenses/​by-​nc/​4.​0/. sionals to know the levels of quality at different stages of care for headache patients. ORCID iDs Patricia Pozo-­Rosich http://​orcid.​org/​0000-​0003-​0796-​4702 Irene Carrillo http://​orcid.​org/​0000-​0002-​6981-​7284 Author affiliations Dolores Jiménez-­Hernández http://​orcid.​org/​0000-​0001-​9424-​6973 1 Service of Neurology, University Hospital Marqués de Valdecilla and Valdecilla Almudena Layos-­Romero http://​orcid.​org/​0000-​0002-​6828-​7808 Biomedical Research Institute, Santander, Cantabria, Spain José Joaquín Mira http://​orcid.​org/​0000-​0001-​6497-​083X 2 Department of Medicine, University of Cantabria, Santander, Cantabria, Spain 3 Headache Unit, Neurology Department, Vall d'Hebron University Hospital, Barcelona, Catalonia, Spain 4 Headache Research Group, Vall d'Hebron Research Institute (VHIR), Universitat Autònoma de Barcelona, Barcelona, Catalonia, Spain REFERENCES 5 1 López-­Bravo A, Bellosta-­Diago E, Viloria-­Alebesque A, et al. 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