Open access Protocol Proactive and systematic multidimensional needs assessment in patients with advanced cancer approaching palliative care: a study protocol Denise Pergolizzi ‍ ‍,1 Iris Crespo,2 Albert Balaguer,1,3 Cristina Monforte-­Royo,4 Alberto Alonso-­Babarro,5 Maria Arantzamendi,6 Alazne Belar,6 Carlos Centeno,6,7 Blanca Goni-­Fuste,4 Joaquim Julià-Torras,8 Marina Martinez,6 Dolors Mateo-­Ortega,9 Luis May,10 Deborah Moreno-­Alonso,11 Maria Nabal Vicuña,12 Antonio Noguera,6,7 Antonio Pascual,13 Encarnacion Perez-­Bret,14 Javier Rocafort,14 Andrea Rodríguez-­Prat ‍ ‍,15 Dulce Rodriguez,16 Carme Sala,9 Judith Serna,17 Josep Porta-­Sales4,18 To cite: Pergolizzi D, Crespo I, Abstract Balaguer A, et al. Proactive and Strengths and limitations of this study Introduction The benefits of palliative care rely on how systematic multidimensional healthcare professionals assess patients’ needs in the needs assessment in patients ►► This study intends to use guidance from the de- initial encounter/s; crucial to the design of a personalised with advanced cancer velopment of complex interventions, employing therapeutic plan. However, there is currently no evidence-­ approaching palliative care: stages for informed development and subsequent a study protocol. BMJ Open based guideline to perform this needs assessment. We implementation of a needs assessment in the first 2020;10:e034413. doi:10.1136/ aim to design and evaluate a proactive and systematic encounter of palliative care, to establish a valid and bmjopen-2019-034413 method for the needs assessment using quality guidelines reliable method for the evaluation of patients. for developing complex interventions. This will involve ►► Prepublication history for ►► Data will be collected from patients, relatives and patients, their relatives and healthcare professionals in all this paper is available online. professionals throughout to ensure representative phases of the study and its communication to offer clinical To view these files, please visit integration of all stakeholders invested in palliative the journal online (http://​dx.​doi.​ practice a reliable approach to address the palliative needs care outcomes. org/​10.​1136/​bmjopen-​2019-​ of patients. ►► Both qualitative and quantitative methods are used 034413). Methods and analysis To design and assess the to inform theory and describe feasibility for use in feasibility of an evidence-­based, proactive and systematic Received 18 September 2019 actual palliative care clinical practice. Multidimensional needs Assessment in Palliative care Accepted 09 January 2020 ►► A feasibility trial will evaluate the needs assessment (MAP) as a semistructured clinical interview guide in clinical practice using mixed methods as well as for initial palliative care encounter/s in patients with report a process evaluation to inform both refine- advanced cancer. This is a two-­phase multisite project ment for future clinical trial and palliative care re- conducted over 36 months between May 2019 and May search of benefits and challenges involved. 2022. Phase I includes a systematic review, discussions ►► The study is limited to being carried out throughout with stakeholders and Delphi consensus. The evidence regions of Spain, which may not generalise to other gathered from phase I will be the basis for the initial clinical contexts and/or professional culture, as does versions of the MAP, then submitted to Delphi consensus only recruiting patient with advanced cancer and to develop a preliminary guide of the MAP for the their families, which limits generalisability to other training of clinicians in the feasibility phase. Phase II is palliative populations. a mixed-­methods multicenter feasibility study that will © Author(s) (or their assess the MAP’s acceptability, participation, practicality, employer(s)) 2020. Re-­use adaptation and implementation. A nested qualitative study permitted under CC BY-­NC. No will purposively sample a subset of participants to add by the results obtained and communication will occur commercial re-­use. See rights preliminary clues about the benefits and barriers of the throughout. and permissions. Published by BMJ. MAP. The evidence gathered from phase II will build a MAP user guide and educational programme for use in clinical For numbered affiliations see practice. Introduction end of article. Palliative care (PC) was originally conceived Ethics and dissemination Ethical approval for this Correspondence to study has been granted by the university research ethics to address the suffering of those dying from Dr Cristina Monforte-­Royo; committee where the study will be carried out (approval advanced disease such as cancer,1 2 but has ​cmonforte@​uic.​es reference MED-2018-10). Dissemination will be informed evolved to providing early PC from diagnosis Pergolizzi D, et al. BMJ Open 2020;10:e034413. doi:10.1136/bmjopen-2019-034413 1 Open access of advanced cancer, and through the trajectory including stunted by the lack of analytical studies that can inform bereavement.3–5 It is estimated that 69%–82% of cancer practice guidelines. deaths would benefit from PC,6 which can improve The current protocol seeks to overcome the abovemen- quality of life,7 patient8 and caregiver distress9 and even tioned limitations and challenges, aiming to develop and survival.10 As a result, there have been multiple calls for test the feasibility of an evidence-­based proactive multi- the integration of PC into standard oncology care to dimensional efficient needs assessment in the initial achieve best outcomes.11–14 With this greater demand for encounter/s with PC. The goal is to design comprehen- PC to improve cancer care throughout the disease trajec- sive and individualised care plans that will ensure equity tory, it is crucial to ensure clinical practice is prepared to in healthcare. We seek to guide and to advance clinical understand and address the palliative needs of patients practice and therefore call this approach ‘MAP: proactive with cancer and their families. and systematic Multidimensional needs Assessment in The WHO defines the success of PC to improve Palliative care’. In addition, the knowledge gathered from quality of life ‘by means of early identification and the research programme will be the basis for an educa- impeccable assessment’. 15 An assessment of needs tional programme on needs assessment in PC that will be at the initial palliative encounter is therefore para- offered to the PC oncology community. This study will lay mount, yet there are no guidelines or evidence-­b ased the groundwork for a future randomised controlled trial standards for this critical aspect of care. Without (RCT). evidence to guide PC practice, healthcare providers often defer to anecdotal or professional experience, 16 Objective which ultimately undermines equitable and compre- This multicenter study aims to design and implement a hensive patient care. 17 18 Clearly, a better approach complex intervention that will proactively and systemat- to the comprehensive assessment of PC needs is ically assess the multidimensional needs of patients with urgently required, using evidence-­ b ased methods advanced cancer and their families when first assessed by that are supported by standards of high-­q uality cancer a PC team. care. 17 19 Evidence suggests providers lack consensus on the Study setting multiple dimensions that appropriately assess PC needs Nine different centres will participate and recruit according to patient and family member perspectives. patients. Five are public health university hospitals, two According to the WHO, minimum goals of PC include concerted-­public health university hospitals, one private assessment of physical, psychosocial and spiritual prob- university hospital and a concerted-­public health long-­ lems.15 Meanwhile, a review of PC literature showed term hospital. 62% of studies in the field limited their focus to phys- ical or psychosocial symptoms.20 Given that unmet needs are associated with increased healthcare costs21 and Patient and public involvement increased distress, which can reduce survival,7 22 the goals Patients and the public were not involved in the of PC should be to ensure that all possible dimensions are design of the complex intervention; however, patients assessed in an efficient way. and their relatives will be involved throughout both Current research also overwhelmingly shows that assess- phases to inform the development and feasibility of ments are based on tools,23 that are neither personalised the MAP. The nature of the MAP is to explore and nor implemented for practice. Tools focus on merely address the needs of patients, thus patient feed- identifying needs, but cannot permit the patient or family back is likewise included to assess the burden of the to express and explore issues with provider, nor replace a MAP, rating its acceptability and that it is not time-­ meaningful initial encounter that builds the therapeutic consuming, during phase II. Plans to communicate alliance.24 Self-­ report tools place the burden on the project goals and findings are aimed at engaging patient, but the patient cannot always communicate what the public with the study objectives and preliminary their care priorities are without empathic feedback.25 results through a website along with a twitter account What is needed is evidence for a feasible and efficient with specific hashtag designed to communicate prog- (being thorough in an acceptable amount of time) semi- ress throughout the development of MAP. structured clinical interview guide for the comprehen- sive needs assessment that providers can implement in practice. A further issue is with the quality of evidence in service Methods and analysis of clinical guidelines for PC. In 2009, the topic of PC was The study is guided by an established framework for covered by <1% of cancer research.20 The level of research developing complex interventions,28 and is divided into evidence has been deemed as low-­ quality evidence in two phases (figure 1): phase I will gather evidence to various aspects of PC.26 27 And two systematic reviews inform the design of the proactive and systematic MAP. highlighted that palliative research is overwhelmed with Phase II will test the feasibility and acceptability of the surveys and descriptive studies.20 27 Thus, the field is MAP in a mixed-­methods prospective cohort study. The 2 Pergolizzi D, et al. BMJ Open 2020;10:e034413. doi:10.1136/bmjopen-2019-034413 Open access summarises similarities or patterns between data derived from different methodologies (ie, quantitative, quali- tative, mixed methods). Because the goal is to use this Figure 1 Study design phases of development and method to look for similarities according to the needs evaluation of the MAP toward a future intervention to be reported and assessed in the literature, the analysis will tested in a RCT. MAP, Multidimensional needs Assessment in inform the interview guide with open-­ended questions Palliative care; RCT, randomised controlled trial. that probe the broad areas of need (eg, specific physical or psychological symptoms) found to be relevant from study will be conducted over 36 months from May 2019 the review. The aim will be to explore the key issues that to May 2022. appear in the literature, to allow participants to define how these needs relate to their perceived needs and Phase I—gather evidence to inform the design of the develop an understanding of their care priorities in an proactive and systematic MAP open discussion. Objectives To define, develop and reach consensus on the design of Stage 2: developing theory the MAP in three stages: Objective: To engage discussions with key stakeholders 1. Stage 1—identifying the evidence base. (individual semistructured interviews with patients and 2. Stage 2—developing theory. their relatives, a nominal group with healthcare profes- 3. Stage 3—modelling process and outcomes. sionals) to develop knowledge and build a framework of how to proactively and systematically assess the needs of Stage 1: identifying the evidence base patients in PC. Objective: To perform an integrative systematic review of the methods used in the PC literature for the assessment Eligibility criteria of needs and whether they correspond to all multidimen- Eligibility criteria for all participants, as well as pertaining sional needs reported by patients. specifically to the patients, relatives and professionals, are Procedure: An integrative systematic review of the summarised in table 1. literature began in May 2019 according to the require- ments of the Preferred Reporting Items for Systematic Sample size review and Meta-­Analysis Protocols guidelines.29 Details Semistructured interviews with patients and relatives are submitted as a protocol in PROSPERO (International PC teams from participating centres will offer consecu- prospective register of systematic reviews). Following data tive patients participation in the study, who will be asked extraction from the full-­ text stage, and an integrative if they have a family member interested in participating. method of analysis by the team,30 a semistructured inter- Individual in-­depth interviews will be carried out with view guide will be developed for Stage 2. This integrative 10–12 patients with cancer and 10–12 relatives, separately. review uses a data reduction method, clustering original The number of participants is estimated based on recom- articles according to a developed coding scheme that mendations in the qualitative literature to focus not on Table 1 Study population criteria for phase I, stage 2 Inclusion Exclusion All participants Age ≥18 Age <18 Speak and understand Spanish or Catalan   Cognitive capacity to communicate clearly   Freely accept participation in the study and sign informed consent   Patients Advanced illness   Receiving PC   ECOG status 0–3   Inpatient or outpatient Patients receiving PC at home Without cognitive failure ≥5 fails on Pfeiffer questionnaire52 Relatives Caregiver responsible for patient   Present at initial visit of patient from PC   Familiar with diagnosis and prognosis of patient   Professionals PC doctors or nurses with an active role in the assessment of the   patient in PC ECOG, Eastern Cooperative Oncology Group; PC, palliative care. Pergolizzi D, et al. BMJ Open 2020;10:e034413. doi:10.1136/bmjopen-2019-034413 3 Open access number of participants but the adequacy of information relevance of the preliminary version according to obtained from interviews.31 Thus, this sample size reflects experts in PC. a range that is recommended as adequate to achieve Procedure: By means of the information from the semi- data saturation; that is, the point where themes from any structured interviews and nominal group with patients, further participant would be redundant.32 33 relatives, PC professionals, a preliminary version of the MAP will be developed. The focus of development of the Nominal group with healthcare professionals MAP will be to create a semistructured interview guide In November 2018, in the context of a workshop we for clinical practice, which will provide a systematic way formed a work group with PC expert clinicians and to ensure inquiry into the necessary topics that are most researchers from 12 institutions throughout Spain (Barce- relevant for the patient. lona, Girona, Lleida, Madrid, Pamplona and Tarragona). To develop the interview guide that those in the The nominal group will be constituted of, among others, field of PC would use in clinical practice, we will seek these PC experts from various disciplines: nurses, physi- consensus from a larger group of 30 to 40 national cians, psychologists and social workers. All experts who experts about the contents of the MAP using the Delphi participate will have (1) more than 5 years of experience technique.38 Participants in the Delphi process will be in PC and/or (2) be hospital service chiefs of PC. The selected by means of intentional sampling from partici- group size of 12 is consistent with the literature using the pating centres with at least one of the following criteria: nominal technique (for review see McMillan et al34), and health professionals with clinical experience in the is sufficient in this context given it exceeds recommenda- field of PC, and/or researchers with knowledge and/ tions of only seven per group.35 or experience related to the patients’ assessment in PC. In order to achieve a high-­quality Delphi process, Procedure a heterogeneous group of experts will be recruited, Researchers trained in qualitative methods will lead the selected from across various geographical regions and interviews and nominal groups. To maintain objectivity, from different professional fields. Potential participants these researchers will not be involved in patient care will be contacted by email and informed about the aims nor study design. Furthermore, the participants will be of the study, the tasks involved and the estimated neces- encouraged to comment on any aspect relevant to them, sary time commitment. The experts who agree to partic- acknowledging there are no right or wrong responses ipate will provide responses through sequential online expected from the interviewer. Finally, results will be anal- questionnaires completed individually and anony- ysed by a team including researchers not involved in data mously until consensus is reached. The key strengths of collection to avoid possible bias. this approach are the anonymity of participants, struc- turing of the information flow and provision of regular Individual semistructured interviews feedback coordinated by the research team. The ques- Two researchers will lead individual interviews using a tionnaire will be formed by using statements that break- semistructured interview guide focusing on multidimen- down each of the topics and questions that comprise sional needs of patients receiving PC. Opinions will be this preliminary version of the MAP. explored through a guided discussion about the needs For each statement, each participant has to rate assessment they experienced and what ways they felt satis- their agreement on a five-­ p oint scale (5=strongly fied or would make recommendations for improvement. agree to 1=strongly disagree). Space is also provided for participants to make comments and/or suggest an Nominal group alternative. We will carry out a number of rounds until Face-­to-­face discussions will occur after the following four a consensus is reached (approximately 2–3). In the stages of the nominal group: (1) generating ideas, (2) first round, each concept must achieve a rating of ≥4, discussion, (3) summary and conclusions and (4) ranking which according to established methods, 34 must reach or individual prioritisation.34 a consensus of 80% to be accepted and included in the second round for rerating of items. The first round Data analysis also serves to determine if any changes to wording The semistructured interviews will be audio-­ recorded of statements are required for re-­e valuation. In the and transcribed verbatim. Thematic analysis of the data second round, each participant receives only the will be performed.36 37 Scores based on rankings from statements that reached consensus, along with person- the nominal group will be recorded into Microsoft Office alised information regarding their previous rating for Excel (version 16.31) spreadsheets. We will calculate the each statement and the comments provided by others sum of the scores for each idea and frequency of votes to for reference. If all statements do not achieve 80% create a list of priorities in order of highest frequency. agreement, this step is repeated in a third round for further and final consensus on what statements will be Stage 3: modelling process and outcomes included in the version of the MAP that professionals Objective: To draft the MAP as a semistructured clin- will receive training on for feasibility testing in the ical interview guide for PC practice and evaluate the next phase. 4 Pergolizzi D, et al. BMJ Open 2020;10:e034413. doi:10.1136/bmjopen-2019-034413 Open access whom often have had prior contact with PC teams during Table 2 Intervention eligibility criteria previous hospital visits. Inclusion Exclusion A nested qualitative study will be carried out, in which 13 Advanced cancer data-­ rich participants will be purposively sampled for Age ≥18 years Age <18 years interviews, to add preliminary clues about the benefits ECOG performance status 0–3 and barriers perceived by patients with advanced cancer Inpatients or outpatients Home care patients who have been assessed with the MAP, one relative of No cognitive failure ≥5 fails on Pfeiffer’s the patient and PC health professionals in charge of questionnaire52 conducting the MAP (table 3). All will be informed of Referred to PC the study to obtain verbal and written consent prior to participation. ECOG, Eastern Cooperative Oncology Group; PC, palliative care. Intervention This is a mixed-­ methods phase II multicenter cohort Data analysis study on the use of the MAP in patients with advanced Data will be analysed by two members of the research cancer. It is conceived as an implementation feasibility team. Questionnaire responses will be entered into study to be carried out in the initial clinical encounter/s spreadsheets and will be calculated using the algo- with a specialised PC team. rithm proposed by Tastle & Wierman.39 This calcula- tion provides the weighted targeted agreement for each Quantitative procedures statement, meaning statements rated as ‘4’ (ie, ‘agree’) PC teams will implement the MAP defined and agreed and above are assigned higher weights and summarised on from development in phase I. The MAP may be as a percentage that are dispersed within that range of integrated with standard oncological care or where responses for each statement. PC is a main attending service. The PC team members Once the MAP preliminary semistructured clinical conducting the MAP will introduce themselves as per interview guide is developed, the coordinators from each usual, and will explain the nature of the procedure participating clinical centre, as well as the teams of PC and its goals. Patients who give their consent to assess professionals that will participate in the next phase of the feasibility of the MAP will be referred to a clinical implementation of the MAP, will receive the appropriate encounter using the MAP (note that the final time training to homogenise its practice. assigned to the encounter will be decided as part of the Phase II: a mixed-methods prospective cohort study consensus process of phase I). Some critically ill or frail Objectives patients could require to split the time into two evalua- To implement a multicenter complex intervention tions. Patients who do not give consent receive the usual testing the feasibility of the newly designed MAP among assessment of PC. PC patients, their families and healthcare professionals. Sample size Eligibility criteria It is an accepted standard in the literature that feasi- Eligibility criteria are defined in table 2. Consecutive participants will be offered participation. All participants bility studies, as trial runs, do not require power calcu- will have the study explained to them and we will obtain lations.40 41 A sample size between 24 and 50 has been both verbal and written informed consent. Patients with recommended.42–44 We will plan to recruit 34–35 eligible advanced cancer are as defined by the American Society of consecutive patients per center (total of 9 centers). This Clinical Oncology: distant metastases, late-­stage disease, will provide a total sample size of 312 patients, and a 15% cancer that is life limiting and/or with prognosis of 6 attrition rate based on the research teams’ experience, to 24 months.13 Because we are interested in the initial which estimates a final sample of approximately 265 encounter/s, we will not include home care patients, patients to exceed recommended sample sizes. Table 3 Participant selection for the nested qualitative component of the intervention Patients Purposively sampled from the feasibility trial considering different sociodemographic characteristics, health status, family support, etc, in order to achieve maximum variability. Relatives The palliative healthcare professional will identify the relative who has been present during the MAP to participate. PC health professionals Members of the PC services involved in carrying out the MAP will participate in focus groups. MAP, Multidimensional needs Assessment in Palliative care; PC, palliative care. Pergolizzi D, et al. BMJ Open 2020;10:e034413. doi:10.1136/bmjopen-2019-034413 5 Open access Table 4 Quantitative outcomes and analyses to assess the feasibility of the MAP intervention Outcomes Definition Measurement Criteria Analysis Acceptability Patient’s opinions of the Likert scale (0 completely ≥75% patients score ≥2* Participants with appropriateness of the inappropriate; 3 extremely rating ≥2 coded as ‘1’; MAP appropriate). else ‘0’. =(∑‘1’/N) *100 Participation Proportion of eligible Number of patients who ≥75% of eligible patients are Eligibility rate: patients with cancer who completed assessment via assessed # eligible (I); # are assessed following the MAP divided by the consented (C) = (I/C) the MAP total number recruited and *100 consented Practicality Time for execution Time elapsed in minutes ≥75% of the MAP completed =Total min to in the agreed on time from complete MAP/ phase I finalised agreed on time in minutes Adaptation Clinician’s perceived Likert scale (0 completely ≥75% clinicians score ≥2 Participants with acceptability for clinical useless; 3 highly useful) rating ≥2 coded as ‘1’; utility else ‘0’. =(∑‘1’/N) *100 Implementation The success of execution Researchers will check ≥80% of the dimensions of =Completion score a standardised template the MAP are covered in the from template *100; of the encounter9 for clinical encounters must be ≥80% completeness *Patient and relative’s acceptability will be reported (relative’s score will be considered as a secondary outcome). MAP, Multidimensional needs Assessment in Palliative care. Outcomes having finished the MAP; and the relative interview as soon Outcomes to assess feasibility are explained in table 4. as possible after having conducted the patient interview to These outcomes were chosen to explore feasibility as avoid data contamination through patient–family conver- recommended by the literature.45 sations. Interviews will be audio-­recorded and transcribed verbatim. Statistical analysis PC health professionals’ perspectives will be gathered Analyses are outlined in table 4. Descriptive statistical anal- through focus groups that will be conducted in participating yses done for feasibility data will be compared with feasi- settings by an expert in qualitative research. In total three bility criteria values (eg, ≥75%) and reported as success or focus groups will be carried out. Participants will be anony- failure to meet criteria proposed. A subanalysis will provide mised by assigning them a code. Focus groups will explore a centre-­by-­centre comparison, with Analysis of variance strengths and weaknesses of the MAP, with reference to (ANOVA) performed per criterion value between centres both their view on patients’ and relatives’ reactions, and to determine statistically significant differences. Bonferroni their own role within the study including the MAP delib- post-­hoc comparisons between centres will be carried out if eration and integration within available resources (practi- an overall significant difference is observed. cality) and setting context (adaptation). Focus groups will Qualitative procedures be audio-­recorded and transcribed verbatim. Participants who have participated in the quantitative portion of the feasibility study will be informed about Sample size the specific objectives of the qualitative interviews. Partic- Qualitative interviews ipants’ attitudes towards participation in this additional Patients. Data will be collected until saturation is reached. phase of data collection will be queried. Sample size is estimated to be approximately 15–20 Individual semistructured interviews will be carried out patients, a documented sample size range that allows us to with patients and relatives separately. An interview guide explore as many possible themes that arise as possible.46 will be developed aligning with the feasibility criteria to Relatives. Data will be collected until saturation is explore acceptability, perceived benefits and concerns and reached. Sample size is again estimated to be approxi- adaptation in the form of reactions to the content and mately 15–20 relatives (one for each patient). process of the MAP. During the interview, the participants Healthcare professionals. As PC services usually consist of will be encouraged to comment on any aspect relevant to a limited number of health professionals, we expect that him. Interviews will be conducted by experts in qualitative there will not be need to sample, as the whole sample research in three settings; three types of hospitals (public, will participate. Data will be collected until saturation private, concerted) in separate autonomous regions. The is reached. In cases where there is a team that has many patient interviews will be conducted with 24–48 hours after health professionals, different health professionals will be 6 Pergolizzi D, et al. BMJ Open 2020;10:e034413. doi:10.1136/bmjopen-2019-034413 Open access purposefully selected up to a maximum of 10 participants Maintenance (REAIM) model (table 5).48 Outcomes in each setting. will be incorporated back into the development of the Analysis. Thematic analysis36 37 of transcribed individual intervention by explaining whether or what changes to interviews and focus groups data will be conducted. To the MAP may be needed for a feasible use in practice. ensure the validity and reliability of the results, the data will The process data will be reported with trial outcomes be analysed independently by a qualitative expert familiar to generate hypotheses and research questions to be with the context of the data collection centre and another addressed for the future RCT. researcher. During data analysis, a consensus process between the researchers at the separate sites will devise a Ethics and dissemination coding framework to review and guide the analysis of data Findings from the feasibility study and process evaluation and direct the thematic presentation of findings. Two will be used to inform appropriate dissemination strate- workshops will be conducted during the analysis process gies. We will use an Evidence-­based Model for the Transfer to enhance adequate analysis process between researchers. and exchange of Research Knowledge ‘EMTReK’,49 which The draft of the results will be shared across with the PC is specifically designed to support knowledge transfer and professionals involved on the MAP for their inputs and to exchange given the challenges of working with vulnerable ensure external validity. A 2-­day workshop will be conducted populations in PC research. with all the partners to reach a final agreement on the anal- ysis results themes and culminate in the final reports. Discussion Timeline This project aims to offer clinicians a proactive and Data collection for the mixed-­methods cohort study will systematic method for a multidimensional needs assess- occur over 26 months, from March 2020 through May 2021. ment in the initial encounter/s, deemed acceptable by The design of MAP will occur over months 1–10, training of all its stakeholders. The development and evaluation of professionals will occur between months 8 and 10, along- the MAP is guided by standards on how to build evidence side recruitment from months 8 to 16, followed by data towards long-­ term implementation of complex inter- analysis and preparation of manuscripts from months 16 ventions.28 Given existing evidence alongside evidence to 26. collected from stakeholders, we anticipate the content of the MAP will adhere to other consensuses of best Process evaluation methods for a needs assessment in PC. This will include In addition to feasibility study outcomes, and given calls assessing multiple symptoms from multiple domains,50 to combine evaluation of outcomes with an evaluation of and allowing for open-­ended questions that practitioners intervention process,47 we will perform a process evalua- can flexibly adjust to each patient’s needs51 within a tion using the Reach, Efficacy, Adoption, Implementation, feasible and practical time frame. We will implement the Table 5 Process evaluation definition, outcomes and analyses Acronym Focus Definition Measurement Analysis R Reach Participation Consent rate defined as number Analysis of variance on consent rate of participants recruited/number to determine differences between of participants approached for each centre* participation E Efficacy Positive and Negative Interview questions probing positive Qualitative analysis according to Reactions and negative responses to methods themes of benefits or issues arising used from all stakeholders during intervention A Adoption Different Settings’ Success rate defined as Analysis of variance on success ease of integration proportion=total number of patients rates by centre to determine if any who completed intervention/ significant regional differences across intended N settings exist* I Implementation Adherence to Professional responses in Qualitative sub-­analysis for themes protocol qualitative interviews probing if any that arise according to question aspects were unclear or difficult to regarding difficulties in use of the MAP implement the intervention M Maintenance Intervention sustained Mean recruitment rates (N per Analysis of variance on mean over time month) across centres for each recruitment rate, analysing differences month in recruitment rate over time* *Bonferroni post-­hoc analysis carried out if significance observed. MAP, Multidimensional needs Assessment in Palliative care. Pergolizzi D, et al. BMJ Open 2020;10:e034413. doi:10.1136/bmjopen-2019-034413 7 Open access MAP in a small-­scale study to examine feasibility that will ORCID iDs allow us to evaluate and refine content towards evalua- Denise Pergolizzi http://​orcid.​org/​0000-​0002-​8357-​9462 Andrea Rodríguez-­Prat http://​orcid.​org/​0000-​0001-​6382-​243X tion in a future RCT. In turn, this project aims to provide structured teaching courses on a multidimensional needs assessment in PC in the near future. References We propose that development of the MAP will respond 1 Clark D. From margins to centre: a review of the history of palliative to an urgent need to investigate the most effective but care in cancer. Lancet Oncol 2007;8:430–8. 2 Saunders C. The evolution of palliative care. J R Soc Med time-­efficient method to assess multidimensional needs 2001;94:430–2. of patients with cancer. 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Hospital Universitari Vall d’Hebron, Barcelona, Spain 18 15 World Health Organization. WHO definition of palliative care, 2016. Institut Català d’Oncologia Girona, Girona, Spain Available: Http://www.Who.Int/Cancer/Palliative/Definition/En/# 16 Krouse RS, Rosenfeld KE, Grant M, et al. Palliative care research: Contributors DP drafted the manuscript. IC provided critical review and revisions. issues and opportunities. Cancer Epidemiol Biomarkers Prev ABa, CM-­R and JP-­S contributed the conception of study design as well as 2004;13:337–9. 17 Bowles EJA, Tuzzio L, Wiese CJ, et al. Understanding high-­ methodology and analysis alongside AA-­B, MA, AB, CC, JJ, MM, DM-­O, LM, DM-­A, quality cancer care: a summary of expert perspectives. Cancer MNV, AN, AP, EP-­B, JR, DR, CS, JP-­S. DP, IC, BG-­F and AR-­P contributed intellectual 2008;112:934–42. content and development of the protocol. All authors reviewed and revised the 18 Snyder CF, Dy SM, Hendricks DE, et al. Asking the right questions: manuscript before submission and approved its content. investigating needs assessments and health-­related quality-­of-­life questionnaires for use in oncology clinical practice. Support Care Funding This work was supported by Instituto de Salud Carlos III, Fondo Europeo Cancer 2007;15:1075–85. de Desarrollo Regional (FEDER) grant number PI19/01901. 19 Kaasa S, Caraceni A. Palliative cancer care research. Palliat Med Competing interests None declared. 2010;24:259–60. 20 Hui D, Parsons HA, Damani S, et al. Quantity, design, and scope of Patient consent for publication Not required. the palliative oncology literature. Oncologist 2011;16:694–703. 21 Balboni T, Balboni M, Paulk ME, et al. Support of cancer patients' Ethics approval Full ethical approval for this study has been obtained from the spiritual needs and associations with medical care costs at the end university ethics committee leading the study (approval reference MED-2018-10). of life. 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