key: cord-1007038-4qz1xw87
authors: Ambrosio, Leire; Hislop‐Lennie, Kelly; Barker, Hannah; Culliford, David; Portillo, Mari Carmen
title: Living with Long term condition Scale: A pilot validation study of a new person centred tool in the UK
date: 2021-03-15
journal: Nurs Open
DOI: 10.1002/nop2.859
sha: c81061e747caee3d74e6322aecd12fcddb002460
doc_id: 1007038
cord_uid: 4qz1xw87

AIM: To cross‐culturally adapt and determine the preliminary psychometric properties of the English version of the LwLTC Scale in people living with long‐term conditions in the UK. DESIGN: Cross‐cultural adaptation and cross‐sectional study. METHODS: Forty‐nine patients with five long‐term conditions were included in the pilot study. Patients completed the English version of the LwLTC Scale and a bespoke questionnaire related to the scale. Feasibility/acceptability, internal consistency and construct validity were analysed. RESULTS: 59.2% of participants were female, with an average age of 65.9 (SD = 12.30). Cronbach's alpha coefficient ranged between 0.50 and 0.84. Content validity showed that the English version of the LwLTC Scale was useful even negative items were identified. CONCLUSION: These preliminary psychometric properties are satisfactory and promising. Further psychometric analyses are needed to verify them in a larger and more representative sample size during the main validation study, which is now in process.

Nowadays, health care and policy attention are changing the focus from the illness to the person and how he/she lives with a LTC (World Health Organization (WHO), 2020). In this regard, the phenomena "living with an LTC" has gain a meaning that goes beyond the biomedical features, integrating the psychosocial and spiritual individual experience (Ambrosio, Senosiain, et al., 2015; Department of Health, 2012) . Living with one or more LTCs is understood as a complex and unique process that involves key elements, namely Acceptance, Coping, Self-management, Integration and Adjustment (Ambrosio et al., 2016; Ambrosio, Senosiain, et al., 2015; Navarta-Sánchez et al., 2017; Portillo et al., 2012; Zaragoza et al., 2014) .

Living with one or more LTCs is a personal experience that can be influenced by several factors, such as previous life experiences, personality types, values and beliefs, and social support (Ambrosio, Senosiain, et al., 2015; Portillo et al., 2012; Zaragoza et al., 2014) .

Therefore, considering personal factors related with the person's and his/her daily living is paramount to achieve a positive living and promoting a better quality of life and psychosocial well-being (Ambrosio et al., 2019; Ambrosio, Senosiain, et al., 2015; Haahr et al., 2010; Kang & Ellis-Hill, 2015; May et al., 2016; Navarta-Sanchez et al., 2016 Prizer & Browner, 2012) .

Existing care guidelines and pathways reflect the complexity of the process of living with LTCs and put people at the centre of the decision-making process (Lim et al., 2017; Navarta-Sanchez et al., 2016; Pemberton, 2014) . However, the design of these care pathways is limited by the lack of comprehensive assessment tools that clearly represent personal needs and daily routines and life with LTCs (Kang & Ellis-Hill, 2015; Navarta-Sánchez et al., 2017; Prizer & Browner, 2012; Soundy et al., 2014) . Most relevant available instruments measure specific aspects related to LTCs (social support, symptoms, severity of conditions, coping skills) or outcomes of the process of living with LTCs (quality of life, satisfaction with life) leading to a fragmentation of the assessment of needs and consequently, care plans (Ambrosio & Portillo, 2018; Martinez-Martin et al., 2014; Mendes, 2015) . Tools such as the Long-Term Conditions Questionnaire (Potter et al., 2017) , the Survey on living with chronic diseases in Canada (Public Health Agency of Canada, 2009) or the Minnesota Living with heart failure questionnaire (Rector et al., 1987) are measures that have been developed potentially to evaluate the process of living with an LTC from the patient perspective. However, these instruments do not accurately evaluate the process of living with an LTC because they assess other related constructs like quality of life Ambrosio & Portillo, 2018) . The Long-Term Conditions Questionnaire (Potter et al., 2017) is the only measure that actually evaluates how people live with/manage their LTCs. This measure is a patient-reported outcome tool that has been validated in a wide and representative sample of patients living with LTCs in three regions of England (Potter et al., 2017) . Despite the potential relevance of the Long-Term Conditions Questionnaire in clinical practice and research, there is no clarity about the interpretation and utility of its general punctuation for referral processes and implementation of care pathways and the omission of items to assess the levels of acceptance of LTCs (Ambrosio, Senosiain, et al., 2015) , which are essential in this process.

Based on this to our knowledge, the Living with Long term condition Scale (LwLTC Scale) could become the only available personcentred tool that captures the individual perception of daily living with LTCs (Ambrosio & Portillo, 2018) cross-culturally. Until now, the LwLTC Scale has only been available in Spanish and has been successfully validated in several prototypical LTCs, such as Parkinson's disease, chronic heart failure, chronic obstructive pulmonary disease, diabetes mellitus type 2, rheumatoid arthritis and hypertension (Ambrosio et al., , 2016 . However, the English version has not been developed yet leaving an important gap related to reliable and valid person-centred tools to evaluate the process of living with LTCs in English-speaking countries.

Based on this, the aim of this study is to produce an English version of the LwLTC Scale and establish if it can be useful and applicable to an English-speaking population with LTCs in the UK. More concretely, two specific aims were proposed: a) to cross-culturally adapt the Spanish version of the LwLTC Scale to an English-speaking population and b) to determine the preliminary psychometric properties of the English version of the LwLTC Scale in a pilot study before the main validation.

A pilot observational and cross-sectional study was carried out in the Wessex Area of the UK.

The aim of this process was to translate and cross-culturally adapt the original LwLTC Scale (Spanish language) to make it suitable for an English-speaking population living with LTCs. According to international standardized protocols for cross-cultural adaptation (International Test Commission, 2010; Sousa & Rojjanasrirat, 2011; Wild et al., 2009 ) and after obtaining written permission from the original author of the LwLTC Scale, the translation and cross-cultural adaptation process were conducted by a panel of four experts. Those experts were native English speakers from different countries and ensured that the English version of the LwLTC Scale was acceptable for all English-speaking countries and not just for British English speakers. In addition, approval of the English version was sought from the original author of the LwLTC Scale in Spanish language. The translation and cross-cultural adaptation process are described in Figure 1 .

A group of PPI representatives including 8 people living with rheumatoid arthritis (RA), Parkinson's disease (PD), diabetes mellitus type 2 (DM2), chronic heath failure (CHF) and chronic obstructive pulmonary disease (COPD) and multimorbidity, in several cases, was organized in order to consult them and gather their feedback in relation to the project plan and the LwLTC Scale. The dynamic of the session followed thus a) presentation of the research team and the project; b) material facilitation and brief period to review it; c) discussion in groups and in pairs about the material, regarding questions such as the relevance and usefulness of the scale in clinical practice and for their daily living, the appropriateness of the length, or misunderstanding items; d) summary of the main ideas; and e) further collaboration at a later stage in the project. The PPI event was totally voluntary and without economic remuneration.

A consecutive case sampling (Bowling, 2014; Peduzzi et al., 1996) was applied to participant identification in the community from the Wessex Area in England. The sample was composed of people living with RA, PD, DM2, CHF and COPD that meet the following inclusion criteria: having been diagnosed with one or more of the LTC by a GP or consultant (RA, PD, DM2, CHF and COPD); being able to read, understand and answer written questionnaires; living in the community and not being hospitalized in moment of the study; being a native English speaker;

and being able to provide written informed consent. Exclusion criteria were as follows: having cognitive deterioration and/or current psychiatric disorders, or any other disorder that could interfere with or impede the study, such as answering self-reported scales, and not meeting established inclusion criteria.

Payo, 2006), a sample size of minimum five and a maximum of ten patients per condition was established. Thus, for this pilot study a sample size of 25-50 patients living with at least one of the LTCs was sought.

Mirroring 

shielding and lockdown measures were implemented during the data collection of this project. Therefore, we needed to introduce a new procedure for data collection that aligned to the lockdown and social distancing measures instructed by the UK Government and prioritized the safety and vulnerability of the participants. The new procedure for data collection was as follows: a) an email invitation was sent to potential participants; b) those interested in the study were asked to send an email to the project generic email address; c) a member of the research team related to this study, replied with a standard email asking to complete the electronic informed consent form and arranging an interview appointment. During the telephone interview, the participant read their own questionnaires and then told the researcher their answers. The telephonic data collection took shorter time than face to face, with an average of 30 min per participant.

Socio-demographic data such as age, gender, marital status, ethnicity, employment, economical situation and educational level were collected. Also, LTC historic data were collected, including age at diagnosis, duration of LTC, treatment or surgery for LTC, and multimorbidity.

The LwLTC Scale is a self-reported measuring instrument to evaluate the complex process of living with LTCs with a personcentred approach . It is a 26-item Scale grouped in five domains: 1-Acceptance (4 items), 2-Coping (7 items), 3-Self-management (4 items), 4-Integration (5 items) and 5-Adjustment (6 items). Items are scored on a 5-point Likert Scale ranging from 0 (never/nothing) to 4 (always/a lot), except for domain 1-Acceptance that ranges in the opposite direction (4: never/nothing to 0: always/a lot). Total score ranges from 0 (most negative living with PD) to 104 (most positive living with PD) . The results from the first validation study in Spanishspeaking population living with Parkinson's disease showed satisfactory psychometric properties (Cronbach's alpha values ranged between 0.68 and 0.88 and internal validity correlations ranged from 0.46 to 0.78) (Ambrosio et al., 2016) .

In addition to the scales and socio-demographic form described above, participants were asked to complete a bespoke questionnaire related to the adequacy and relevance of the LwLTC Scale and format aspects in the target population. This was used to understand the adequacy and relevance of the scale and format aspects in the target population.

The aim of every pilot study is to replicate the formal validation study in a small sample size in order to identify necessary modifications (misunderstanding words, procedure problems, etc.) and

consequently achieve an instrument that is as clear and concise as were used to determine the socio-demographic and clinical characteristics of the participants. Main data were ordinal or did not fit normal distribution; therefore, non-parametric statistics were used.

In order, the following psychometric attributes were tested:

Feasibility and acceptability. Quality of data was considered satisfactory if 95% of the data were computable. The limit for missing data was < 5% (Smith et al., 2005) and floor and ceiling effect were deemed acceptable if they were < 15% (McHorney & Tarlov, 1995) .

Cronbach's alpha coefficient (criterion value > 0.60) (Aaronson et al., 2002) , item-total correlation (corrected for overlap; criterion value, r s ≥ 0.30) (Hobart et al., 2004) and item homogeneity (criterion value > 0.20) (Eisen et al., 1979) .

The following types of validity were evaluated: content, internal and known-groups validity. Content validity was established through a bespoke questionnaire related to the LwLTC Scale and the PPI group. Data were qualitative and were analysed by the research team. Internal validity between the LwLTC Scale dimensions was measured using the standard r s = 0.30-0.70 (Hobart et al., 2004; van der Linden et al., 2005) and known-groups validity was also evaluated for gender, marital status, educational level, employment status and type of LTC (Fayers & Machin, 2007) .

Mann-Whitney and Kruskal-Wallis tests were used for group's comparison.

Data analysis was undertaken with the software package SPSS 25.0.

The study was approved by the Ethics Committee of the University of Southampton (ERGO) (reference number 53,537) and by all the voluntary organizations participating in the study. All participants gave their signed consent to participate in a voluntary way in the study after receiving the pertinent written and verbal information.

All data, including information on the participants' identity, were handled in full confidentiality throughout the research process.

Is it important to highlight that every change and/or modification carried out in the study methodology, as for example data collection procedure due to the COVID-19, were newly approved by the pertinent ethics committee after sending amendments to meet governance requirements and ensure researchers and participants safety.

A total sample of 49 patients living with RA, PD, DM2, CHF and COPD was included in this pilot study of the LwLTC Scale English version.

TA B L E 1 Socio-demographic characteristics of the total sample and historical data of the long-term conditions (n = 49) Abbreviations: CHF, chronic heart failure; COPD, chronic obstructive pulmonary disease, SD, standard deviation; DM2, diabetes mellitus type 2; PD, Parkinson's disease; RA, rheumatoid arthritis.

As shown in Table 1 , from the total sample 59.2% were female, and 71.4% were married, with an average age of 65.9 (SD = 12.30). More than the 50% of the sample had primary and secondary level education and 65.3% were retired. The mean duration of the LTC was 15.6 (SD = 14.3) years. See Table 1 for further detail of the total sample and specificities for each LTC.

Regarding feasibility and acceptability, there were no missing data, except in item 23 (domain 5-Adjustment). Results for the domains of the LwLTC Scale English version did not show floor or ceiling effects (2.0% and 4.1%, respectively) and all items reached the maximum score range, except for item 14 (domain 3-Self-management). For further information, see Table 2 .

As shown in Table 3 , results related to internal consistency of the total sample show that Cronbach's alpha coefficient ranged between 0.50 (domain 3-Self-management) and 0.84 (domain 2-Acceptance).

Item homogeneity index values were higher than 0.20 for all domains and item-total corrected correlation values ranged from −0.14 to 0.80.

See Table 3 for further detail of internal consistency for the total sample.

Regarding internal validity of the LwLTC Scale, as shown it 

The overarching aim of this pilot study was to produce an English Internal consistency was also adequate for the domains of the scale, although domain 3-Self-management was the only one that presented results slightly below the established criteria for the total sample. Various studies (Kang & Ellis-Hill, 2015; Zaragoza et al., 2014) show the suitability of the items contained in the selfmanagement domain and, therefore, this result could be considered acceptable. Item homogeneity was over the minimal standard threshold for all domains, and the domains 3-Self-management and 4-Integration, did not show adequate coefficient values according to the standards. This means that some of the items grouped in domains 3-Self-management and 4-Integration may be wrongly grouped, measuring perhaps other related concepts. This has not been found in previous pilot or validation studies carried out in other countries, like Spain (Ambrosio, Navarta-Sanchez, Meneses, et al., 2020; Ambrosio et al., 2016) and were considered surprising because the LwLTC Scale was developed based on important conceptual and empirical work, (Ambrosio, Senosiain, et al., 2015; Portillo et al., 2012; Zaragoza et al., 2014) .

Nevertheless, this should be interpreted with caution because of the size of the study sample (n = 49). Therefore, further analyses will be needed in the main validation of the scale to confirm or discard this.

In relation to the preliminary results related to the validity of the LwLTC Scale, overall, results were satisfactory. Regarding content validity, participants described the LwLTC Scale as a useful tool that helped them to express their daily concerns about the disease. The usefulness and adequacy of the scale have also been highlighted in previous pilot studies carried out in a Spanishspeaking population (Ambrosio, Navarta-Sanchez, Meneses, et al., 2020; . However, due to the cultural differences between countries (Spain and UK) some of the participants in the present study expressed their disagreement with some items regarding the ambiguity of the meaning like the use of the word "fight." Due to this cultural discrepancy, and following the cross-cultural adaptation of the Spanish version of the LwLTC Scale to the English culture, the verb "fight" was replaced by the verb "face." This change was made in accordance with the original author of the scale.

Regarding the internal validity, a strong correlation was identified among the five domains of the scale, except in one of the items values regarding domain 1-Acceptance (0.20). This low value is coherent and could be explained by previous conceptual and empirical studies carried out in the living with LTC field (Ambrosio, Navarta-Sanchez, Meneses, et al., 2020; Ambrosio, Senosiain, et al., 2015; Portillo et al., 2012; Zaragoza et al., 2014) where Acceptance is considered an internal, illnessindependent process through which the person with LTCs recognizes and assumes that presents an LTC. Moreover, accepting the disease is always the starting point for living successfully with an LTC (Ambrosio, Senosiain, et al., 2015) . Thereby, for this pilot study we Chronic heart failure 47.0 ± 13.9

Chronic obstructive pulmonary disease 74.1 ± 8.3

Note: Mean ± standard deviation. Mann-Whitney test for gender, Kruskal-Wallis test with Bonferroni correction for the rest of variables.

*p <.05 statistically significant.

Taking into account emerged results in this pilot study, the English version of the LwLTC Scale is a potential clinical measure to be used by nurse professionals. Apart from apparently presenting satisfactory psychometric results as it was identified in this study, the LwLTC Scale is a short, easy and comprehensive measure to use in everyday practice. Through this scale, nurses could quickly identify how the person is living with one or more than one LTC and consequently prevent further complications and unnecessary use of resources and services. In particular, nurses could provide the patients with specific and individualized choices, such as coping skills and/or adjustment strategies in order to achieve a positive living with the LTC (Ambrosio, Senosiain, et al., 2015) . Consequently, patients will become more autonomous and will know how to face with the LTC and deal with complications it and reducing nurses' workload. This study also presents several strengths such as the prototypical and diversity of LTCs selected, the reach of participants through a community approach instead of just through the healthcare system, and a strong PPI strategy and input. Besides, the general approach of this study was to develop one language version of the LwLTC Scale that could be used in all countries in which English is spoken. The benefit of this approach is that the final translations should not require further adaptation for other countries although testing with patients in new countries would be recommended. Finally, even the recruitment process during the lookdown of COVID-19 was a challenge, through this pilot study we had the opportunity to identify the versatility in the use of the LwLTC Scale, which could be applied face to face or remotely through telephone interview.

The preliminary psychometric properties of the English version of the LwLTC Scale are satisfactory and promising. However, these results do not automatically guarantee the success of the LwLTC Scale in clinical practice and research in the UK. This pilot study is just a first approximation of the scale in a small sample size of Englishspeaking people living with LTCs in the UK. Therefore, cautious interpretation is needed and high expectations are in place for the main validation study, which is now in process.

The authors would like to thank the NIHR Applied Research

Collaboration Wessex for the financial support in the development of this project. Besides, the authors really appreciate FACIT services for the transcultural adaptation of the scale. The authors also would like to acknowledge the collaboration of people with long-term conditions in the project.

The authors declare having no conflict of interests.

Ambrosio L is principal author of the original scale in Spanish, interpreted the results, drafted the whole article and approved the final version for publication. Hislop-Lennie K contributed to project conception, data collection, critical revision and substantial contribu- the precision, transparency and honesty of the data and information contained in the study; additionally that none of the relevant information has been omitted and that all discrepancies among the authors have been adequately solved and described.

The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.

https://orcid.org/0000-0002-9450-7210

Mari Carmen Portillo https://orcid.org/0000-0003-1583-6612

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