Patients and healthcare professionals perspectives on creating a chronic pain support line in Portugal: A qualitative study protocol.

Chronic pain affects almost 38% of the Portuguese adult population, with high costs for both patients and society. Those who suffer with chronic pain frequently complain of feeling misunderstood and of lack of support. These complaints are the main reason why support telephone lines for chronic pain were created in some countries. However, there is no scientific data supporting their creation or evaluating their performance. This paper presents a qualitative study protocol to assess patients and healthcare professionals' perspectives on the creation of a telephone support line for chronic pain. It constitutes the first step to attain the main goal of developing and implementing a functioning support line for chronic pain in Portugal. The methodology to assess patients and healthcare professionals' perspectives and needs is presented. In order to gather information as close to reality as possible, focus groups interviews were chosen as data sources. Given the present context of the COVID-19 pandemic, meetings will take place online, using a digital platform. All interviews will be transcribed verbatim, coded and synthesised into categories and main themes. Thematic analysis will be conducted using NVivo® V12 software, employing an iterative and reflexive approach. Finally, comparative and relational analysis will be performed in order to identify topics where patients and professionals converge or greatly diverge. The findings will be useful for grounding the creation of a telephone support line for chronic pain patients. Results dissemination will be important for policy-makers to develop a new perspective towards chronic pain services available.

Introduction

According to the International Association for the Study of Pain (IASP), pain is “an unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage” and a major cause of suffering and disability in the world [1, 2]. As for chronic pain, it is defined as pain that persists or recurs for longer than 3 months and is associated with significant emotional distress or functional disability [1]. In 2001, the European Federation of Pain (EFIC) recognised chronic pain as a pathology in itself, whether isolated or accompanied by other disorders [3]. It should be noted that chronic pain can be divided into primary chronic pain (without an obvious cause), or secondary chronic pain (as a symptom of an underlying pathology, including cancer, post-surgical, post-traumatic, neuropathic, orofacial, visceral and musculoskeletal pain) [1].

Recent studies revealed that chronic pain prevalence in European adult population is of 20%, with similar numbers being found in the US [4, 5]. Among the adult Portuguese population, prevalence exceeds 30%, making it a major public health problem [6]. The consequences are not only personal but also societal, such as the costs of absenteeism, early retirement and social benefits. These aspects contribute to total annual costs of 5,635.26 million euros per year in Portugal. Despite these numbers, the same study concluded that only 1% of Portuguese chronic pain patients has access to specialized follow-up [7].

There is a particular duality to chronic pain in Portugal: access to care is somewhat restricted (given the difficulties in having access to a family physician, it is even more difficult to access chronic pain specialists), but when someone uses health services because of their pain, there is a tendency for over-using it, with no clinical gain [7, 8]. For this reason, there is a need for interventions that bring patients and healthcare professionals closer, in order to empower those who suffer and maximize the effective use of the available resources [7]. The maximization of services includes avoiding its unjustified use (providing patients with tools for pain prevention and management) and tackling major issues, such as treatment adherence (taking the correct dosage, of the correct medicine, on a timely manner and during the prescribed time of treatment).

The information described so far partly justifies the creation of a chronic pain support telephone line, as it will facilitate access to healthcare professionals, providing empathic listening, patient rehabilitation, empowerment and appropriate referral, while also making it possible to implement adherence enhancing interventions. There are some pain support lines already functioning in some countries, namely in Ireland, Canada, England and Australia [9-12]. Most of these lines are volunteer-operated and were created by private or aid organizations. Consequently, they are not submitted to performance evaluation. Nevertheless, recent experiments with telecare for chronic pain patients show positive impact regarding disease management, and users’ testimonies reinforce the importance of human presence for the patient suffering with chronic pain [13].

Considering the high prevalence of chronic pain in Portugal, it would be important to have such a support service for those living with the disease. A telephone support line would be available for patients living in both metropolitan and rural areas, whether they are housebound or not. This would make healthcare access more equal, extending support to anyone who needs it and has access to a telephone, with a relatively widespread, inexpensive and accessible technology. Simultaneously, it would make possible to tackle major issues such as healthcare services overuse and medication adherence, contributing to an important reduction of costs [13, 14].

Collecting the opinions and perspectives of patients with chronic pain and healthcare professionals working in the area is essential, as this is the only way to provide a truly objective ground for the creation of a support line. This information will allow the development of a project based on the reality of those who live with the disease on a daily basis, a foundation that will permit, in the long term, a precise and objective evaluation of the results and impact of the support line.

In order to gather such information, a direct interaction with chronic pain patients and healthcare providers is needed, preferably in a group setting. Being so, the decision for focus group interviews was made, for this method allows to obtain a diverse array of perspectives, as close to everyday reality as possible.

To our knowledge, this is the first qualitative study that aims to objectively validate the creation of a support line, as well as gathering information that is essential to the development of a service adapted for those who will benefit from it [13, 14].

Materials and methods

Aims and objectives

The study will be conducted under the scope of the project “Creating a pain support line in Portugal: feasibility, development and impact”. Its main objective is the creation of a telephone support line for chronic pain patients. More specific objectives are: 1) evaluating chronic pain patients and healthcare professionals needs and expectations (including what kind of services are expected), 2) developing a decisional algorithm that provides adequate advice for each situation, 3) providing healthcare professionals that will operate the line with specific training on chronic pain, 4) supplying confidential support to those in need while assuring communication between multiple agents in healthcare services and 5) warranting flexibility and respect for patient and healthcare professionals individuality. This study protocol will focus mainly on the first objective, describing the qualitative study designed to fulfil it.

Study design and setting

In order to evaluate chronic pain patients and healthcare professionals’ needs and expectations, an exploratory and phenomenological qualitative design study will be performed. As such, different qualitative methods were considered to determine the best data collection procedure, such as semi-structured interviews, focus groups, questionnaires, among others. After careful consideration, the research team opted in favour of direct interaction with chronic pain patients and healthcare providers, in line with the notion that human interaction plays an essential part in chronic pain management. By interacting with subjects in a controlled group setting, that is, performing focus group interviews, one can obtain a diverse array of perspectives, as close to everyday reality as possible. This is particularly effective because group discussions with peers provide participants with a safe and familiar environment to express their opinions and describe their experiences [15]. Ideally, the focus groups would consist of an in-person gathering, which would allow information other than spoken words, such as body language and posture for example, to be registered. However, due to COVID-19 pandemic restraints, the focus groups will take place via online videoconference, using the "Zoom" platform. The recommendations for online focus-groups are that the number of participants do not exceed five to six, because a fluid discussion is difficult to obtain otherwise [16, 17]. Thus, we aim to have minimum of 1 group for both patients and healthcare professionals, composed of 5 to 6 participants each.

After being invited to participate, a presentation regarding focus groups dynamics and videoconference characteristics and requirements will be held for both patients and healthcare professionals who volunteer to participate, before the meetings themselves have place. They will also be informed that all meetings will be recorded and transcribed verbatim, always in accordance with the Portuguese data protection laws.

Qualitative data will be analysed with the NVivo® V12 software to provide evidence to guide the creation of the support line. The next step of this project consists of evaluating the feasibility of creating a decisional algorithm, through collaboration with a panel of researchers with competencies both on the field of chronic pain and on informatics, particularly on decisional algorithms. The algorithm will then be subjected to all the necessary corrections and adjustments, which will be possible with the creation of a test-line to be assessed with the collaboration of patients and healthcare professionals. The pivot-line will then be amplified, according to stakeholders’ decisions and resources available.

Participants

The study will be presented by the research team to an Association of People with Pain (Força-3P) and to the Portuguese Association for the Study of Pain (APED) members, who will serve as a connection between the research team and those who volunteer to participate in the study. The following characteristics will be considered as inclusion criteria of participants: being 18 years or older, having the ability to understand and communicate in Portuguese, being able to use technologies and log in a Zoom call, and being a chronic pain patient (diagnosed at least 2 years ago) or a healthcare professional working with chronic pain patients.

Healthcare professionals

Healthcare professionals (e.g., medical doctors, nurses, psychologists) will be volunteers from different areas of healthcare that deal with chronic pain, such as palliative care nurses and oncologists, for example. After attending the presenting session, a date will be arranged for the focus group. Written consent will be obtained prior to the meeting.

Chronic pain patients

Patients will be recruited by the representatives of the National Association of People with Chronic Pain (Força-3P), who will reiterate that participation is voluntary. In case of agreement, the representatives will send an e-mail to the patient, inviting them to the presentation session. Then, the representatives will help establishing communication between the patients and research team, in order to arrange meeting details. Written consent will be obtained beforehand.

Data collection procedures

The online focus group sessions are set to be synchronous and to last from 60 to 90 minutes [17]. An entirely online approach was chosen to ensure safety of participants in times of pandemic. The participants will be free to choose to use a codename, so that they may remain anonymous. Each group will be led by two moderators with backgrounds in research and work on chronic pain. They will be present 30 minutes before the starting time to solve any technical issues. The principal investigator will act as a group facilitator and guide the interview, following a semi-structured focus group guide designed to elicit participants’ experiences. The second moderator will be responsible for recording major quotes, non-verbal interactions, and expressions, in order to add context to the recordings and aid discussion of the transcripts later on. Each focus group session will include an overview to introduce the objective, a series of questions which proceed from general to specific, and a summary to highlight and verify key points discussed (Tables and ) [15].

The major topics covered in the focus groups are based on literature regarding chronic pain patients and healthcare professionals’ experiences, as well as on topics related to technology potential and applications [18-24].

This approach will enable the researchers to collect information about the patients’ and healthcare professionals’ perceptions regarding the services currently available, needs that remain to be met and expectations for a chronic pain support line.

Data analysis

All focus group data will be transcribed verbatim and anonymized. After that, thematic and content analysis will be performed through an iterative and reflexive process, carried out by two researchers working independently. Next, the transcripts will be imported into the NVivo®12 software and codification will take place [25]. Coding of the segments of the transcriptions will be made quotation by quotation [26]. The segments of coded text will be synthesised into categories, which will be further grouped into main themes [27, 28]. Findings will emerge directly from raw data, firstly using an inductive coding technique and, after that, applying the deductive approach to the same transcript. Each technique will be carried out independently for the patients and for healthcare professionals focus groups, in a systematic, sequential, and continuous way. The use of two coding techniques is expected to reduce possible bias of the codifiers.

Analysis of the obtained data will be made according to the framework method. In a first stage, each focus group will be analysed separately, through a detailed description and interpretation of main themes, comparing the results of both coding techniques. In the next step, comparative and relational analysis from both focus groups will be carried out, in order to identify how the perspectives of chronic pain patients and healthcare practitioners may converge or diverge in specific topics.

All data will be discussed and interpreted by 3 researchers, the 2 codifiers and a third researcher to provide another perspective and help solve disagreements. Eventual discrepancies in codification will be discussed until consensus is reached. All findings will be reported following the COREQ guideline (Consolidated Criteria for Reporting Qualitative Research) [29].

Data management

Data retrieved from focus groups will be recorded, anonymised, analysed and published. It will be preserved in private folder, protected with password, in a secure computer, for the researchers’ use and validation purposes only. There is no intention to reuse this data; thus, it will be stored until conclusion of the main project and destroyed afterwards.

Ethical considerations

The protocol of the project “Creating a pain support line in Portugal: feasibility, development and impact.”, in which this study is integrated, was approved by the Ethics Committee of the Centro Hospitalar Universitário de São João, Faculty of Medicine of University of Porto (109–21). An information sheet with a description of the study and its objectives will be given to all participants, providing them ways to contact the research team. Each participant will be given a written informed consent for the interview recordings and collected materials. All data will be anonymous and confidential. Data protection will be ensured by separating audio records, transcripts, consents and questionnaires, as well as by using passwords to access them. Any code linking data to individuals will be safely stored and only accessible to the research team. All participants will be anonymous throughout the entire study and its dissemination, from a data interpretation perspective.

Discussion

To our knowledge, this will be the first study to gather scientifically grounded data to support the development of a chronic pain support line, through patients and healthcare professionals’ perspectives. This knowledge will also enable us to objectively evaluate the impact that the line may have. Rigorous standards of qualitative research, such as dependability, credibility, confirmability and transferability will ensure that the findings obtained are consistent with the methods of the interpretivist paradigm and its information sources [27, 30].

The study has some anticipated limitations that should be mentioned. A potential limitation is the possibility of over-representation of groups that are more likely to participate in a time-consuming activity like the focus groups, such as unemployed people or people on sick leave. Likewise, convenience sampling is not an ideal sampling method, and we can foresee that our sample will not an ideal representation of the whole national population with chronic pain. Given that the organizations of contact are seeded in an urban environment, it is expected there to be some underrepresentation of rural population, for example. These limitations are, at least during this time of pandemic, when access to healthcare services is restricted to those who need them, difficult to overcome. However, the gathered data will still be very useful, and a significant first step in the qualitative approach to a better understanding of the needs and expectations of Portuguese chronic pain patients and healthcare practitioners. Moreover, it will also provide new insights on how a support telephone line might attend to the identified needs, while allowing for a better use of healthcare services. The added value of this study lies on its concern with underlying perceptions, needs and attitudes towards the use of technology as a means of bringing support closer to and helping those who suffer with chronic pain. Finally, the combined perspectives of both potential users (chronic pain sufferers whom might benefit from the support line) and healthcare professionals, ensures that all relevant views are taken into account.

This qualitative study will allow us to gather evidence on the real-life chronic pain context and ensure that every step of the project will be linked to the real needs of those to whom the support line is intended. Moreover, this protocol could constitute a useful tool to encourage other researchers towards the development of a chronic pain support line, as it fosters the application of a widespread and accessible technology.

Results will be published in international peer-reviewed journals and presented in conferences. Furthermore, the end results will be disseminated nationally in seminars directed to the general public and policy-makers in the health and social sectors.

26 May 2022

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Reviewer #1: Thanks for the Authors for the valuable protocol that looks in an issue which require a good care. looking forwards to see the study manuscript and its results.

Reviewer #2: The manuscript written by Cruz et al describes the procedure implemented by the researchers in order to gather patients’ and healthcare’s professional standpoints about the Implementation of a support line for chronic pain patients in Portugal.

I have some concerns about the information provided by the authors that merit further consideration:

In my opinion, the main problem of this manuscript that there are major gaps in the information provided in terms of the preparation of the scientific protocol and the presentation of the results. The latter are reduced to few paragraphs in the discussion without sharing the real numbers obtained from the study which makes impossible to elaborate an exhaustive review of the present manuscript.

Even though authors make clear the need for such support line and the potential benefit for the Portuguese population suffering of chronic pain, there are some gaps in the elaboration of the context:

- In line 58, the authors cited “recent studies” that revealed the prevalence of chronic pain in Europe and the US. However, those references dated from 2016 and 2013, which makes me wonder if there are not more recent studies that could be more accurate with the present situation, moreover, taking into consideration the advances in pain management that have occurred in the last year.

- In line 64, the authors mentioned that access to care is “somehow restricted” but it is not specified why or where. Are they talking in general in the developed countries? Only in Portugal? Why access to care is restricted and for whom? As this is one of the central pillars to justify the need of implementing the support line, it should be much more elaborated and rationalized.

- In line 76, it is mentioned that there are currently similar systems already implemented in different countries. Please add here references or links to those systems to help both the reviewers and the readers to get an idea. Moreover, authors explain how those lines previously referred, are having a positive impact on user’s lines. However, the reference alludes to a study performed in the US (not even mentioned among the countries listed before).

- Taking into consideration the very well know differences between the healthcare systems across countries and how different the access to basic or specialized care could be depending on having public, private or semiprivate health infrastructures, I would appreciate that this issue would have been considering when presenting the effect of a support line. Indeed, the explanation for the expected benefit of such implementation in Portugal should have been based on the results obtained in countries with similar systems.

Concerning the Study design, I would appreciate to see a clearer and more detailed timeline of the implementation of the study, including a more exhaustive description of the study groups (number of groups, number of people participating, distribution of participants according to their profiles, gender, age). How were participants distributed in the groups? Has any participant been rejected?

Even if Tables 1 and 2 collect the Major and Specific discussion items, it remains not clear how those aspects were addressed during the meetings.

Nowadays, data privacy is one of the major topics when refers to research involving human beings, even if only healthy subjects are recruited. In that direction, authors have not provided any information concerning where the videos from the groups were stored, how they were protected from being accessed by non-authorized staff, how privacy has been secured…

However, as previously mentioned, the main problem of this manuscript is that the authors do not present any results that can be reviewed or contrasted. They mentioned in line 232 a potential limitation due to an over-representation of groups that the reviewers cannot judge because there is no data provided to support any discussion or conclusion.

Reviewer #3: The authors have presented a nice paper about the protocol adopted to evaluate and validate the possibility to set up "a chronic pain support line" in Portugal.

The topic is important to be discussed and the unmet need of this approach is well described by the authors.

Unfortunately there are some major concerns that should be addressed before considering it for possibile publication

The major concern is a methodological issue that should be better clarified. It is not clear how you have defined the criteria to "balance" chronic non oncological and oncological patients and healthcare providers. This is really important as the two different populations of patients and also of caregiver providers could have different needs.

Another concern is always related to the selection of your population who will evaluate the "support line". In the text it is not described if the authors have taken in consideration how to avoid bias related to select people only from countryside/city, type of pain, etc etc. Please describe better which are all the parameters that you consider in the evolution of patients and healthcare providers selected. If you have not planned it please describe it better in limitations of the protocol

The authors should describe better the protocol in order to permit the possibility to replicate in another country if possible.

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Reviewer #1: Yes: Hossam ELDien A. ELShamaa

Reviewer #2: No

Reviewer #3: Yes: Massimo Allegri

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8 Jul 2022

Editor’s Comments:

"The reviewers have highlighted important aspects to improve this study protocol. Specifically, although there cannot be results (being it a protocol), all methodological aspects needs to be clarified so that this paper can inspire close replication and close/similar research in the field."

-We thank the reviewers for their valuable insight, and have further detailed the study’s methodology. Please find the appropriate changes in the updated document.

"Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. (…)"

-The manuscript’s formatting has been revised, and we believe it is compliant with PLOS ONE’s requirements.

"In your Data Availability statement, you have not specified where the minimal data set underlying the results described in your manuscript can be found. PLOS defines a study's minimal data set as the underlying data used to reach the conclusions drawn in the manuscript and any additional data required to replicate the reported study findings in their entirety. All PLOS journals require that the minimal data set be made fully available."

-This study has no results description as it is a protocol. In the Data Availability Statement, we will make all data used to reach the work’s conclusions when we have results (“All relevant data from this study will be made available upon study completion.)

"Upon re-submitting your revised manuscript, please upload your study’s minimal underlying data set as either Supporting Information files or to a stable, public repository and include the relevant URLs, DOIs, or accession numbers within your revised cover letter."

-Since our work is a study protocol and there are no results, all the information available and relevant has been detailed in the manuscript.

Your ethics statement should only appear in the Methods section of your manuscript. If your ethics statement is written in any section besides the Methods, please delete it from any other section.

-This issue has been rectified as instructed.

_______________________________________________________________________________________________________________________________________________________________________

Reviewers' Comments:

Reviewer #1:

“Thanks for the Authors for the valuable protocol that looks in an issue which require a good care. looking forwards to see the study manuscript and its results.”

-We would like to thank reviewer #1 for their positive reception of our manuscript; it encourages us to keep working on this project.

Reviewer #2:

(…) “there are major gaps in the information provided in terms of the preparation of the scientific protocol and the presentation of the results. The latter are reduced to few paragraphs in the discussion without sharing the real numbers obtained from the study which makes impossible to elaborate an exhaustive review of the present manuscript.”

-We thank reviewer #2 for their remark. Since this is a study protocol, there are no results to be reported in this manuscript. Nevertheless, we have strived to be as transparent as possible and predict the project’s evolution as best as one can without incurring in biases. As such, it is specified that the results will be reported according to the COREQ guideline, ensuring the scientific soundness of our work (Please see the Data Analysis subsection in the Materials and Methods section, particularly the last paragraph).

“Even though authors make clear the need for such support line and the potential benefit for the Portuguese population suffering of chronic pain, there are some gaps in the elaboration of the context:

- In line 58, the authors cited “recent studies” that revealed the prevalence of chronic pain in Europe and the US. However, those references dated from 2016 and 2013, which makes me wonder if there are not more recent studies that could be more accurate with the present situation, moreover, taking into consideration the advances in pain management that have occurred in the last year.”

-We agree with reviewer #2’s assertion that it is important to include recent studies in order to strengthen our contextualization. In fact, we did include references to two studies that were written in 2013 and 2016 (references 4. and 7.), because we believe they are still very effective in providing context to the current impact of chronic pain; however, it is also referrenced on the same line (line 58) a study published in 2021 on Pain (reference 5.). Furthermore, other recent studies are focused on specific populations and not chronic pain patients in general. Finally, even though we recognise the importance of recent advances in pain management, we believe this is a different topic, which does not pertain to what is being discussed in the mentioned manuscript excerpt, i.e. chronic pain prevalence.

“- In line 64, the authors mentioned that access to care is “somehow restricted” but it is not specified why or where. Are they talking in general in the developed countries? Only in Portugal? Why access to care is restricted and for whom? As this is one of the central pillars to justify the need of implementing the support line, it should be much more elaborated and rationalized.”

-We thank reviewer #2’s constructive remark. We have changed the wording on that sentence, by adding more detail and, thus, making the meaning clearer.

“- In line 76, it is mentioned that there are currently similar systems already implemented in different countries. Please add here references or links to those systems to help both the reviewers and the readers to get an idea. Moreover, authors explain how those lines previously referred, are having a positive impact on user’s lines. However, the reference alludes to a study performed in the US (not even mentioned among the countries listed before).”

-We very much appreciate reviewer #2’s insight. The mentioned excerpt was indeed quite confusing and somewhat incomplete. We have rectified this in the updated version.

“- Taking into consideration the very well know differences between the healthcare systems across countries and how different the access to basic or specialized care could be depending on having public, private or semiprivate health infrastructures, I would appreciate that this issue would have been considering when presenting the effect of a support line. Indeed, the explanation for the expected benefit of such implementation in Portugal should have been based on the results obtained in countries with similar systems.”

-We find reviewer #2’s comment very pertinent and thank them for their insight. In fact, unfortunately it is impossible to reliably predict the impact of a chronic pain help line in Portugal by comparing it to other lines in countries with similar healthcare systems: chronic pain help lines are rare worldwide, and the examples that exist are pro bono initiatives that are not audited and whose efficacy and impact are not evaluated in any meaningful way. This is one of the reasons we believe our project is so promising and innovative: beyond being a chronic pain help line, it is evidence-based, well-founded in scientific research and taking into account various perspectives from stakeholders. Furthermore, a quality control mechanism will be implemented, and the line’s effectiveness and economic impact will be evaluated.

“Concerning the Study design, I would appreciate to see a clearer and more detailed timeline of the implementation of the study, including a more exhaustive description of the study groups (number of groups, number of people participating, distribution of participants according to their profiles, gender, age). How were participants distributed in the groups? Has any participant been rejected?”

-We understand reviewer #2’s concern, however, since this work is a protocol and there are no participants yet, we cannot provide their description. Nevertheless, we have added more information regarding the sample of patients we expect to gather (please read the final sentence of the first paragraph of the Study design and setting section.

“Even if Tables 1 and 2 collect the Major and Specific discussion items, it remains not clear how those aspects were addressed during the meetings.”

-In Tables 1 and 2, the theme guides for both discussion groups are addressed. We understand the reviewer’s request, but, since this work is a protocol, we cannot provide details about how themes were addressed because the meetings have not yet taken place.

“Nowadays, data privacy is one of the major topics when refers to research involving human beings, even if only healthy subjects are recruited. In that direction, authors have not provided any information concerning where the videos from the groups were stored, how they were protected from being accessed by non-authorized staff, how privacy has been secured…”

-We thank reviewer #2’s reminder of the importance of data privacy and security. In our study, as described in this protocol, we will take all necessary precautions to ensure patient data is handled correctly. Moreover, this manuscript strictly complies with all data protection laws in Portugal and the EU. Firstly, as described in detail, all patients will sign consent forms and have the choice to choose an alias and keep their camera turned off during the focus group session, so that they may remain anonymous. Moreover, all data will be anonymized during the transcription process, making it impossible to trace transcribed statements to the individual who said them. Finally, it was written expressly that all data would be saved in a password-protected folder, only accessible to the research team. We have, however, rewritten this last section and made it clearer (please read

“However, as previously mentioned, the main problem of this manuscript is that the authors do not present any results that can be reviewed or contrasted. They mentioned in line 232 a potential limitation due to an over-representation of groups that the reviewers cannot judge because there is no data provided to support any discussion or conclusion.”

-We appreciate reviewer #2’s criticism. However, this manuscript is a study protocol, so it is impossible to present any results by definition. Moreover, the group representation limitations mentioned are predicted limitations inherent to the methodology; we discuss them in an effort to guarantee transparency and guide future conclusions.

Reviewer #3:

(…) “The major concern is a methodological issue that should be better clarified. It is not clear how you have defined the criteria to "balance" chronic non oncological and oncological patients and healthcare providers. This is really important as the two different populations of patients and also of caregiver providers could have different needs.”

-We thank reviewer #3’s insightful criticism. Although we understand the importance of representativity of different patient groups, we aim to develop a general help line and do not want to artificially influence our sample by ensuring some groups are present in a certain amount. In fact, this would add significant obstacles to our methodology, as we would have to ensure other patient groups are also represented, such as patients with neuropathic, post-surgical or degenerative pain, for example, so that biases are minimised. The target population of the help line is the whole chronic pain population. Perhaps in future studies, when the overall project is in a more advance phase, it would be valuable to obtain perspectives from specific groups within that population, to ensure their particular needs are met. However, as a first step of a long project, we would rather have general sample groups.

“Another concern is always related to the selection of your population who will evaluate the "support line". In the text it is not described if the authors have taken in consideration how to avoid bias related to select people only from countryside/city, type of pain, etc etc. Please describe better which are all the parameters that you consider in the evolution of patients and healthcare providers selected. If you have not planned it please describe it better in limitations of the protocol.”

-We very much appreciate reviewer #3’s constructive criticism. Regarding chronic pain types, as mentioned in the previous reply, we deliberately chose not to differentiate them in this phase, and will contact a general chronic pain patient association. As for the population limitations, we accept this as a methodology by-product. We have further explored this issue in the discussion, and believe it is now more clear and detailed (please read the changes on the second paragraph of the discussion section).

“The authors should describe better the protocol in order to permit the possibility to replicate in another country if possible.”

-We thank the reviewer’s remarks and have extensively rewritten the Materials and Methods section, making it clearer and more detailed.

Submitted filename: Response to Reviewers.docx

Click here for additional data file.

5 Aug 2022

Patients and healthcare professionals perspectives on creating a chronic pain support line in Portugal: a qualitative study protocol.

PONE-D-21-35572R1

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Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #3: Yes

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Reviewer #3: Yes

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Reviewer #3: Yes

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Reviewer #3: No

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Reviewer #3: Yes

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Reviewer #3: The authors have satisfactory replied to all concerns previously raised. The text is now clearer and more readable

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Reviewer #3: No

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9 Aug 2022

PONE-D-21-35572R1

Patients and healthcare professionals perspectives on creating a chronic pain support line in Portugal: a qualitative study protocol

Dear Dr. Cruz:

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department.

If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org.

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on behalf of

Dr. Sara Rubinelli

Academic Editor

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Table 1

Patients’ focus group theme guide.

Major themes	Specific discussion themes
Perspectives on the existing and/or lack of support for patients	· Reaching out for support
	· Types of support needed
Perspectives on accessibility of such support methods	· Support accessibility
	· Enhancing accessibility for all
Perspectives on pain medication adherence	· Effectiveness of pain medication
	· Importance of pain medication to pain management
	· Needs for information regarding pain medication
Perspectives on using information technologies as a mean of support	· Perspectives on using information technologies (such as mobile-phones, apps, e-mails, etc) as support methods
	· Utility of these vehicles of support
	· Usage of these support methods when needed
Perspectives on the creation of a telephone line	· Perspectives on the creation of a support telephone line
	· Needs expected to see fulfilled
	· Reaching to this kind of support when trying to manage pain
	· Applicability of such line in the day-to-day life of patients

Table 2

Healthcare professionals’ focus group theme guide.

Major themes	Specific discussion themes
Perspectives on the existing and/or lack of support for patients	· Effectiveness of existing support
	· Support services available in the healthcare system
	· Knowledge of chronic pain patients’ opinions regarding available support
Perspectives on accessibility of such support methods	· Support accessibility
	· Enhancing accessibility for all
Perspectives on pain medication adherence	· Importance of pain medication adherence
	· The real medication adherence of patients
	· Usefulness of a service potentially providing information regarding pain medication
Perspectives on using information technologies as a mean of support	· Perspectives on using information technologies (such as mobile-phones, apps, e-mails, etc) as support methods
	· Usefulness of these vehicles of support
	· Real-life usefulness of these support methods for patients
Perspectives on the creation of a telephone line	· Perspectives on the creation of a support telephone line for patients
	· Needs expected to see fulfilled
	· Integrating this kind of support in the approach to patients’ care