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Development and content validation of a self-reported functional mobility assessment instrument for older adult patients

Abstract

Objective

To develop and validate the content of the Composite Score for Mobility (COSMO) for assessing self-reported functional mobility in older adults postoperatively after hip fracture.

Methods

A methodological study was carried out involving an expert panel of 30 healthcare professionals with experience treating older patients hospitalized after hip fracture surgery and a user panel of 30 older patients hospitalized after hip fracture surgery. The COSMO was developed as a patient-reported outcome measure (PROM) instrument. Content validity was evaluated by applying the Delphi technique to the panel of judges, and a content validity index (CVI) was determined for each instrument item.

Results

The CVI for the 45 questions answered by the expert judges on the relevance and scope of the COSMO was 100% on 31 questions, 96.7% on 11 questions, 93.3% on one question, and 90% on two questions. Of the 85 questions on the scope, relevance, and understanding of COSMO answered by the 30 user judges, a CVI of 100% was attained for 83 questions and 93.3% on two questions.

Conclusions

The COSMO is a relevant, comprehensive, understandable and valid instrument for assessing self-reported functional mobility in older adult inpatients after hip fracture surgery.

Keywords
Validation Study; Geriatric Assessment; Hip Fractures

Resumo

Objetivo

Desenvolver e validar o conteúdo do Composite Score for Mobility (COSMO) para avaliar a mobilidade funcional autorreferida de pessoas idosas no pós-operatório de fratura de quadril.

Métodos

Um estudo metodológico foi conduzido envolvendo um painel de especialistas composto por 30 profissionais de saúde com experiência com pacientes idosos hospitalizados após cirurgia de fratura de quadril e um painel de usuários composto por 30 pacientes idosos internados após cirurgia de fratura de quadril. O COSMO foi desenvolvido como um instrumento de medida de resultados relatados pelo paciente (PROM). A validade de conteúdo do COSMO foi avaliada pela técnica Delphi e aplicada aos painéis de juízes, sendo calculado o índice de validade de conteúdo (IVC) para cada questão do instrumento.

Resultados

A partir das 45 questões respondidas pelos juízes especialistas sobre a relevância e abrangência do COSMO, foi alcançado IVC de 100% em 31 questões, 96,7% em 11 questões, 93,3% em uma questão e 90% em duas questões. Das 85 questões sobre escopo, relevância e compreensão do COSMO respondidas por cada um dos 30 juízes usuários, foi alcançado um IVC de 100% em 83 questões e um IVC de 93,3% em duas questões.

Conclusão

O COSMO é um instrumento relevante, abrangente, compreensível e válido para avaliar a mobilidade funcional autorreferida em pacientes idosos internados após cirurgia de fratura de quadril.

Palavras-Chave:
Estudo de Validação; Avaliação Geriátrica; Fraturas do Quadril

INTRODUCTION

Hip fractures pose a major challenge for public health worldwide11 Guerra MTE, Vargas MWA, Galia CR. Baixos níveis séricos de vitamina D aumentam significativamente o risco de morte em idosos com fraturas de quadril: coorte prospectiva. Rev Col Bras Cir 2022;49. Disponível em: https://doi.org/10.1590/0100-6991e-20223054
https://doi.org/10.1590/0100-6991e-20223...
,22 Guerra MTE, Viana RD, Feil L, Feron ET, Maboni J, Vargas AS-G. One-year mortality of elderly patients with hip fracture surgically treated at a hospital in Southern Brazil. Rev Bras Ortop. 2017;52:17-23. Disponível em: https://doi.org/10.1016/j.rboe.2016.11.006
https://doi.org/10.1016/j.rboe.2016.11.0...
given their negative impact on mobility, psychosocial factors and quality of life (QoL) in older adults33 Konstantinos IA, Andreas R, Sokratis EV, Konstantinos NM. Quality of life and psychological consequences in elderly patients after a hip fracture: a review. Clin Interv Aging. 2018;(24)13:143-150. Disponível em: https://doi.org/10.2147/CIA.S150067
https://doi.org/10.2147/CIA.S150067...
. This type of fracture can compromise patient gait and lead to potentially fatal complications, such as pneumonia, thromboembolic disease or rhabdomyolysis, particularly in patients who experience long periods of imobility44 Rocha KNS, Delicato LS, de Oliveira NHG, et al. Principíos gerais de gerenciamento de fraturas: Complicações precoces e tardias. Braz J Health Rev. 2022;5(1):304-314. Disponível em: https://doi.org/10.34119/bjhrv5n1-027
https://doi.org/10.34119/bjhrv5n1-027...
.

Validated accurate tools that help define the physical rehabilitation process of patients postoperatively after hip fracture are essential55 Neto F, Lopes M, de Oliveira F, de Vasconcelos Alves F, Melo M, de Souza C. Translation and transcultural adaptation of the Hip Fracture Recovery Score assessment tool. Rev Bras Ortop. May-Jun 2016;51(3):353-65. Disponível em: https://doi.org/10.1016/j.rboe.2015.08.020
https://doi.org/10.1016/j.rboe.2015.08.0...
. However, assessing the physical status of patients postoperatively does not suffice66 Lee KJ, Um SH, Kim YH. Postoperative Rehabilitation after Hip Fracture: A Literature Review. Hip Pelvis. Sep 2020;32(3):125-131. Disponível em: https://doi.org/10.5371/hp.2020.32.3.125
https://doi.org/10.5371/hp.2020.32.3.125...
, since pre-surgical physical-functional independence has a major influence on functional outcome and the post-operative recovery process22 Guerra MTE, Viana RD, Feil L, Feron ET, Maboni J, Vargas AS-G. One-year mortality of elderly patients with hip fracture surgically treated at a hospital in Southern Brazil. Rev Bras Ortop. 2017;52:17-23. Disponível em: https://doi.org/10.1016/j.rboe.2016.11.006
https://doi.org/10.1016/j.rboe.2016.11.0...
. Moreover, instruments based on patient performance and on health professional judgments fail to capture the subjective experience of these patients. By contrast, Patient-Reported Outcome Measures (PROMs) can detect subjective perceptions of these individuals77 Carrozzino D, Patierno C, Guidi J, et al. Clinimetric criteria for patient-reported outcome measures. Psychother Psychosom. 2021;90(4):222-232. Disponível em: https://doi.org/10.1159/000516599
https://doi.org/10.1159/000516599...
and allow shared decision-making that enables patients to be more actively involved in the rehabilitation process88 Hoffmann T, Bakhit M, Michaleff Z. Shared decision making and physical therapy: What, when, how, and why? Braz J Phys Ther. 2022;26:100382. Disponível em: https://doi.org/10.1016/j.bjpt.2021.100382.

One way of determining the validity of an instrument is by content validation, which ensures the research tool captures the phenomenon of interest accurately and comprehensively, while guaranteeing the reliability and validity of results obtained from questionnaires. Content validation also ensures the instrument is both understandable and suitable for the target audience. The content validation stage is fundamental to guarantee that the instrument in question is able to provide accurate predictions in studies of prognostic validity99 Terwee CB, Bot SD, de Boer MR, et al. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. Jan 2007;60(1):34-42. Disponível em: https://doi.org/10.1016/j.jclinepi.2006.03.012
https://doi.org/10.1016/j.jclinepi.2006....
.

Additionally, instruments measuring physical-functional characteristics during the time period between fracture and surgery can be used to produce a score reflecting self-reported mobility. This type of tool can also improve communication among professionals involved in physical-functional recovery, with self-reported disabilities having a bearing on shared decision-making.

At the time of writing, no instruments of this kind assessing both pre and post-operative functional mobility based on self-reports of older patients undergoing surgery for hip fractures were available. Developing and investigating the content validity of a self-report functional assessment tool for older adults hospitalized after hip surgery can be valuable for clinical practice. Therefore, the objective of the present study was to develop and validate the content of the Composite Score for Mobility (COSMO) tool for assessing self-reported functional mobility in older adults after surgery for hip fracture.

METHODs

This methodological quali-quantitative study was conducted at the orthopedics ward of the Teaching Hospital of the Universidade Federal do Vale do São Francisco (HU-UNIVASF), administrated by the Empresa Brasileira de Serviços Hospitalares (EBSERH). The study was performed in accordance with resolutions 466/2012 e 510/2016 of the National Health Board and with the precepts of the Declaration of Helsinki, and approved by the Research Ethics Committee of the Amaury de Medeiros Integrated Health Center (CISAM-UPE) (Permit number 4.673.367). All participants signed the Free and Informed Consent Form previously approved by the local Research Ethics Committee.

The expert panel included health professionals with at least 5 years of clinical practice involving older adult patients hospitalized after surgery for hip fracture. Respondents who failed to complete 100% of the electronic questionnaire were excluded.

Eligibility criteria for inclusion in the user panel were older adults aged ≥60 years, of both sexes, and hospitalized in the orthopedic clinical ward of the HU-UNIVASF with a diagnosis of hip fracture. Exclusion criteria were patients with >4 years of formal education scoring ≤ 24 points on the Mini-Mental State Exam (MMSE) or those with <4 years of formal education scoring 18 points on the MMSE1010 Bertolucci PHF, Brucki SMD, Campacci SR, Julian Y. O mini-exame do estado mental em uma população geral: impacto da escolaridade. Arquivos de neuro-psiquiatria. 1994;52(1):7. Disponível em: https://doi.org/10.1590/S0004-282X1994000100001
https://doi.org/10.1590/S0004-282X199400...
. Patients with clinically-diagnosed Alzheimer Disease, senile dementia or dementia with Lewy bodies, hearing loss or aphasia, were also excluded. The performance of users regarding postural balance, gait and muscle strength of lower limbs was assessed using the Brazilian Short Physical Performance Battery (SPPB), adapted transculturally for older adults1111 NAKANO, MM. Versão brasileira da Short Physical Performance Battery SPPB: adaptação cultural e estudo da confiabilidade. 2007. Dissertação (mestrado) - Universidade Estadual de Campinas, Faculdade de Educação, Campinas, SP. Disponível em: https://hdl.handle.net/20.500.12733/1604495.

The COSMO was developed in accordance with the Consensus-based Standards for selecting health Measurement Instruments (COSMIN)1212 Terwee CB, Prinsen C, Chiarotto A, et al. COSMIN methodology for assessing the content validity of PROMs–user manual. Qual Life Res. 2018;27:1159–1170. Disponível em: https://doi.org/10.1007/s11136-018-1829-0
https://doi.org/10.1007/s11136-018-1829-...
,1313 Terwee CB, Prinsen CAC, Chiarotto A, et al. COSMIN methodology for evaluating the content validity of patient-reported outcome measures: a Delphi study. Qual Life Res. May 2018;27(5):1159-1170. Disponível em: https://doi.org/10.1007/s11136-018-1829-0
https://doi.org/10.1007/s11136-018-1829-...
. Firstly, a review of the relevant literature was carried out to define which items to consider for developing this instrument. Two existing instruments for assessing functional mobility were considered: the de Morton Mobility Index (DEMMI)1414 de Morton N, Davidson M, Keating J. The de Morton Mobility Index (DEMMI): an essential health index for an ageing world. Health Qual Life Outcomes. Aug 19 2008;6:63. Disponível em: https://doi.org/10.1186/1477-7525-6-63
https://doi.org/10.1186/1477-7525-6-63...
, transculturally adapted for Brazilian Portuguese1515 Silva VZM, Lima AS, Alves HNS, Pires-Neto R, Denehy L, Parry SM. Versão Brasileira do teste da Função Física em Unidades de Terapia Intensiva e do De Morton Mobility Index: tradução e adaptação transcultural e propriedades clinimétricas. J Bras Pneumol 2020;46. Disponível em: https://doi.org/10.36416/1806-3756/e20180366
https://doi.org/10.36416/1806-3756/e2018...
, and the New Mobility Score for Predicting Mortality after Hip Fracture1616 Parker M, Palmer C. A new mobility score for predicting mortality after hip fracture. J Bone Joint Surg Br. Sep 1993;75(5):797-8. Disponível em: https://doi.org/10.1302/0301-620X.75B5.8376443
https://doi.org/10.1302/0301-620X.75B5.8...
, used for assessing prior functional mobility of patients.

The first part of the COSMO, containing 8 items, should be answered for the period 1 week prior to the fracture. To this end, patients were asked to describe difficulties a week before the fracture for: 1) going from a lying to sitting position; 2) going from a sitting to lying position; 3) standing from a sitting position; 4) sitting from a standing position; 5) walking to the restroom (around 5 meters from start point); 6) walking around the house or condominium; 7) going out to stroll in their street; and 8) going out to do the shopping.

The second part of the instrument pertains to the post-operative stage and contains 5 items. These items must be assessed daily (preferably at the same time of day) throughout the hospital stay after surgery. This functional information yields a final COSMO score. In this second part of the questionnaire, patients were probed about their current difficulties performing the following tasks:

1) going from lying to sitting position; 2) going from sitting to lying position; 3) standing from sitting position; 4) sitting from standing position; and 5) walking to restroom (around 5 meters from start point). The degree of difficulty self-reported by the patient should be classified as: none (when patient can perform the activity independently); 2) moderate (when the patient can perform the activity with the assistance of another person, or the aid of crutches, walker or wheelchair); 3) intense (when patient can perform the activity with great difficulty i.e., only with the assistance of 2 or more people); and 4) very intense (when patient cannot perform the activity).

Scores for the questions from the first and second parts of the COSMO range from 3 to 0 in descending order representing the sequence between “none” and “very intense”, respectively. Points are summed after completion of the first two parts of the instrument.

The third part of the COSMO involves calculating mobility scores. The partial score is first calculated by adding the “before fracture” and “post-operative” sections together. Subsequently, the number of days the patient was hospitalized prior to undergoing surgery is deducted from the value of the partial score, yielding an absolute final score. The absolute final score is then divided by 39 if the patient was discharged on the 1st post-operative day (POD), by 54 if discharged on the 2nd POD, or by 69 if discharged on the 3rd POD. This allows the relative final score on the COSMO to be calculated.

The maximum score on the first part of the COSMO is 24 points. The scores on the second part are calculated as follows: The maximum score on the 1st, 2nd and 3rd POD are 15, 30 and 45 points, respectively. Also, the number of days the patient was hospitalized from date of admission to day of surgery must be calculated.

The final score on the COSMO is calculated according to the following steps: 1st – Points for functional difficulty before fracture and after surgery are summed; 2nd – Number of days patient was hospitalized is deducted (from date of hospital admission to date of surgery); 3rd – Relative score on COSMO is calculated.

The original version of the instrument in Brazilian Portuguese is shown in Chart 1.

Chart 1
Original Brazilian version of Composite Score for Mobility (COSMO). Petrolina, Pernambuco state, 2024.

Two panels of judges were used in the study to contend validity of COSMO: one comprising experts and the other with users (patients). Interviews were based on a questionnaire containing questions for each domain of the COSMO.

The expert panel was made up of physiotherapists, nurses, orthopedic doctors and occupational therapists chosen based on the importance and diversity of perception of these professions regarding what is relevant or otherwise during the process of self-reported evaluation of this type of patient. These professionals were recruited in a non-probabilistic manner via letter of invitation, followed by the Free and Informed Consent Form, sent via e-mail, instant messaging apps and social networks, between June and September 2021.

The content validity of the COSMO was tested using the Delphi technique, based on data obtained from a panel of 30 expert judges1717 Mokkink LB, De Vet HC, Prinsen CA, et al. COSMIN risk of bias checklist for systematic reviews of patient-reported outcome measures. Qual Life Res. 2018;27(5):1171-1179. Disponível em: https://doi.org/10.1007/s11136-017-1765-4
https://doi.org/10.1007/s11136-017-1765-...
. The Delphi method is a powerful quali-quantitative investigation technique that enables the opinion of geographically distal experts to be pooled1818 Marques J, de Freitas D. The delphi method: characterization and potentialities for educational research. Pro-Posições. 2018;29(2):389. Disponível em: https://doi.org/10.1590/1980-6248-2015-0140
https://doi.org/10.1590/1980-6248-2015-0...
.

After signing the consent form, all of the 30 experts answered a structured questionnaire via Google Forms containing 45 questions on the scope and relevance of the COSMO items. The response options for the questions were: 1) Fully agree; 2) Agree; 3) Neither agree, nor disagree; 4) Disagree; and 5) Totally disagree.

The user panel was made up of patients recruited between September and December 2021 after hospital admission for hip fracture surgery. The patients were asked to perform the specific activities contained in the COSMO. The patients then reported the degree of difficulty performing each task.

After application of the COSMO, users completed a questionnaire based on a paper and pencil interview containing 85 questions on the relevance, comprehensibility and score of the items in the preliminary version of the COSMO. This questionnaire consisted of response options on a Likert-type scale, similar to that used with the panel of experts. The questionnaire was applied by the same physiotherapist (E.A.L) with over 8 years of experience in assessments and therapeutic interventions involving older adult patients hospitalized in an orthopedic clinic for post-operative rehabilitation of hip fractures.

The items from the qualitative analysis were read out aloud by the researcher. Users were then asked to explain what they understood by each item in their own words. If the level of understanding of the COSMO was unsatisfactory, the item was explained and flagged for reworking to improve its comprehension.

For statistical analysis, continuous variables were expressed as mean and standard deviation, whereas categorical variables were expressed as summary measures of absolute and relative frequency. Content validity was rated using the Delphi technique applied qualitatively to the panels of judges. The content validity index (CVI)1919 Shrotryia VK, Dhanda U. Content Validity of Assessment Instrument for Employee Engagement. SAGE Open. 2019;9(1). Disponível em: https://doi.org/10.1177/2158244018821751
https://doi.org/10.1177/2158244018821751...
was subsequently used to quantitatively analyze agreement between the judges. A level of agreement between judges of 85% was adopted as the criterion for good content validity of the instrument devised1212 Terwee CB, Prinsen C, Chiarotto A, et al. COSMIN methodology for assessing the content validity of PROMs–user manual. Qual Life Res. 2018;27:1159–1170. Disponível em: https://doi.org/10.1007/s11136-018-1829-0
https://doi.org/10.1007/s11136-018-1829-...
.

The CVI was calculated using the mean number of valid responses2020 Júnior VAC, Neto SS, Cabral DS, Chermont AG, dos Santos Trindade CBJR, Criação e validação de aplicativo para avaliação de dor infantil. Res Soc Dev. 2021;10(10):e529101017721-e529101017721. Disponível em: http://dx.doi.org/10.33448/rsd-v10i10.17721 obtained by panels of experts and users, as shown in Equation 1.

C V I = Number of “1” or “2” responses Total responses (Equation 1)

RESULTS

Experts were predominantly female, aged 30-39 years, physiotherapists practicing in Pernambuco state, had graduated as professionals 11 years ago or earlier, had over 8 years of experience treating older adult inpatients with hip fractures in hospital wards, and held specialist qualifications (lato sensu) (Table 1).

The data in Table 2 shows that over half of the user panel participants (patients) were female and most aged 60-69 years. Almost half of the participants of this panel had no formal education, while the other half reported having incomplete primary education.

Table 1
Sociodemographic and professional characteristics of participants on expert panel (N=30). Petrolina, Pernambuco state, 2021.

The results in Table 3 show that the majority of the sample were able to walk independently and had good cognitive performance, as measured by the MMSE. Femoral neck fractures and falls from height predominated among these participants. Final score on the COSMO obtained by patients was just over 50%.

Table 2
Sociodemographic characteristics of participants on user panel. (N=30). Petrolina, Pernambuco state, 2021.

Respondents who failed to complete 100% of the pen and paper questionnaire were excluded from the user panel.

As shown in Table 4, for the total 45 questions answered in the first round of analysis by the 30 expert judges on the relevance and scope of the COSMO, a CVI of 100% agreement was attained for most questions and CVI of around 90% for two questions. This percentage CVI was the lowest obtained by the analysis for the expert panel. Thus, no changes to the questions from the questionnaire were necessary, since the minimum level of quantitative and qualitative agreement (80%) was reached in the first round of analysis.

Table 3
Clinical and functional characteristics of participants on user panel. (N=30). Petrolina, Pernambuco state, 2021.
Table 4
Content validity index based on judgment of panel of experts (N=30) and users (N=30). Petrolina, Pernambuco state, 2021.

Also, as shown in Table 4, of the total of 85 questions on scope, relevance and comprehension of the COSMO answered by the 30 judges on the user panel, a CVI of 100% was obtained on more than 80 questions and CVI of over 90% on 2 questions. None of the CVIs among participants in the user panel were below 93.3%. This lower agreement (93.3%) occurred for questions 27 (“Considering the timepoint one week before the fracture, there is no end of key concepts”) and 45 (“Considering the post-surgical timepoint, there is no end of key concepts”).

The CVIs calculated for each item of the instrument, applied to the expert and user panels, can be found in the tables of Supplementary Material 1 and 2, respectively, available from https://doi.org/10.6084/m9.figshare.25726710.v2.

DISCUSSION

The objective of the present study was to develop and validate the content of the Composite Score for Mobility (COSMO) for assessing self-reported functional mobility in older adult inpatients after surgery for hip fracture. The main results of the study reveal that the content of the COSMO exhibited over 96% scope and relevance on more than 90% (42/45) of the items, as rated by the expert panel. Analysis of the user (patient) perceptions showed that the scope, relevance and comprehension of the instrument yielded 100% content validity for 97% (83/85) of the items. Given that none of the questions had an CVI below the 85% agreement threshold established in this study1212 Terwee CB, Prinsen C, Chiarotto A, et al. COSMIN methodology for assessing the content validity of PROMs–user manual. Qual Life Res. 2018;27:1159–1170. Disponível em: https://doi.org/10.1007/s11136-018-1829-0
https://doi.org/10.1007/s11136-018-1829-...
, no changes were made to the final version of the instrument.

Different measures of outcomes assessed and reported by physicians (Clinician Reported Outcome Measures, CROMs) (or other health professionals) and outcomes reported by patients about their perceptions (Patient Reported Outcome Measures, PROMs) are routinely employed to monitor the effects of treatment and post-operative performance results2121 Bily W, Jauker J, Nics H, Grote V, Pirchl M, Fischer MJ. Associations between Patient-Reported and Clinician-Reported Outcome Measures in Patients after Traumatic Injuries of the Lower Limb. Int J Environ Res Public Health. Mar 7 2022;19(5). Disponível em: https://doi.org/10.3390/ijerph19053140
https://doi.org/10.3390/ijerph19053140...
. However, it is important to note that only a moderate association exists between results of PROMs and CROMs, demonstrating that these two types of measure provide different clinical information on the functional status of patients2222 Maly MR, Costigan PA, Olney SJ. Determinants of self-report outcome measures in people with knee osteoarthritis. Arch Phys Med Rehabil. Jan 2006;87(1):96-104. Disponível em: https://doi.org/10.1016/j.apmr.2005.08.110
https://doi.org/10.1016/j.apmr.2005.08.1...
. While the PROM provides information on the experience related to task execution, CROM type instruments yield information about ability for task completion2323 Stratford PW, Kennedy D, Pagura SM, Gollish JD. The relationship between self-report and performance-related measures: questioning the content validity of timed tests. Arthritis Rheum. Aug 15 2003;49(4):535-40. Disponível em: https://doi.org/10.1002/art.11196
https://doi.org/10.1002/art.11196...
.

Of a total 11 instruments identified in a systematic review for assessing mobility of hospitalized older adults, none were of the PROM type or evaluated functional status before hip fracture2424 Menezes KVRS, Auger C, Menezes WRS, Guerra RO. Instruments to evaluate mobility capacity of older adults during hospitalization: A systematic review. Arch Gerontol Geriatr. Sep 2017;72:67-79. Disponível em: https://doi.org/10.1016/j.archger.2017.05.009
https://doi.org/10.1016/j.archger.2017.0...
. Such instruments capture the subjective perception of these individuals77 Carrozzino D, Patierno C, Guidi J, et al. Clinimetric criteria for patient-reported outcome measures. Psychother Psychosom. 2021;90(4):222-232. Disponível em: https://doi.org/10.1159/000516599
https://doi.org/10.1159/000516599...
and enable shared decision-making that helps patients play a more active role in the rehabilitation process88 Hoffmann T, Bakhit M, Michaleff Z. Shared decision making and physical therapy: What, when, how, and why? Braz J Phys Ther. 2022;26:100382. Disponível em: https://doi.org/10.1016/j.bjpt.2021.100382. This kind of instrument can be used to improve perioperative care, by accounting for pre-operative functional impairments, as well as post-operative follow-up2525 Kim S, Duncan PW, Groban L, Segal H, Abbott RM, Williamson JD. Development and Implementation of a Tool to Assess Patient-Reported Outcome Measures (PROM) in Preoperative Setting. Glob J Perioper Med. 2017;1:017-21. Disponível em: https://doi.org/10.17352/gjpm.000005
https://doi.org/10.17352/gjpm.000005...
. Against this backdrop, the present study results confirming the content validity of the COSMO reveal this to be a promising approach for self-reported functional assessment of this clinical goal. The fact that patients do not need to perform any physical-functional test at the post-fracture and post-surgical stages renders COSMO a safe instrument for obtaining data on physical-functional mobility in the hospital setting.

Also, it is noteworthy that surgery wait times after hip fracture can impact 30 and 90-day survival rates2626 Beaupre LA, Khong H, Smith C, et al. The impact of time to surgery after hip fracture on mortality at 30- and 90-days: Does a single benchmark apply to all? Injury. Apr 2019;50(4):950-955. Disponível em: https://doi.org/10.1016/j.injury.2019.03.031
https://doi.org/10.1016/j.injury.2019.03...
. Older patients appear to be at greater risk of death due to surgical delays than younger patients. Hence, two patients with the same pre-fracture functioning may have very different prognoses at hospital discharge, depending on the length of time awaiting surgery and length of post-operative hospital stay2626 Beaupre LA, Khong H, Smith C, et al. The impact of time to surgery after hip fracture on mortality at 30- and 90-days: Does a single benchmark apply to all? Injury. Apr 2019;50(4):950-955. Disponível em: https://doi.org/10.1016/j.injury.2019.03.031
https://doi.org/10.1016/j.injury.2019.03...
. Therefore, the COSMO was devised to provide a cumulative composite tool for assessing functional status before surgery and during hospital stays pre and postoperatively. PROM-type instruments can be used to improve pre-operative care by providing an assessment of pre-operative functional impairments and post-operative follow-up of patients2525 Kim S, Duncan PW, Groban L, Segal H, Abbott RM, Williamson JD. Development and Implementation of a Tool to Assess Patient-Reported Outcome Measures (PROM) in Preoperative Setting. Glob J Perioper Med. 2017;1:017-21. Disponível em: https://doi.org/10.17352/gjpm.000005
https://doi.org/10.17352/gjpm.000005...
. Taken together, these attributes render the COSMO a promising self-report functional assessment for use in routine clinical practice of hospitals.

Another strength of the study was the diversity of the professionals on the expert panel. The physiotherapists, for example, were directly involved with patients from pre-operative rehabilitation through to discharge2727 Hartman J, Duttine A. Rehabilitation 2030: a collective call that requires individual action. Braz J Phys Ther. 2022;26(2). Disponível em: https://doi.org/10.1016/j.bjpt.2021.06.004
https://doi.org/10.1016/j.bjpt.2021.06.0...
. The nurses play an important role in changing decubitus, mobility for washing, and changing clothes or diapers2828 Soares AB, Silva AM, da Silva GD, et al. A assistência de enfermagem ao paciente submetido à artroplastia total de quadril e a importância dos cuidados no período pós operatório. Rev Recien. 2013;3(7):11-18. Disponível em: 10.24276/rrecien2177-157X.2013.3.7.11-18. Orthopedic doctors are responsible for surgical treatment and therefore engage in shared decision-making on subsequent therapeutic approaches to improve the physical mobility of these patients2929 Luthi F, Pereira LC, Jolles BM. Os 12 pontos-chave da reabilitação após artroplastia total do joelho. Rev Soc Bras Clin Med. 2015;13(4):303-309. Disponível em: http://files.bvs.br/upload/S/1679-1010/2015/v13n4/a5192.pdf. Occupational therapists are responsible, among other duties, for assessing the functional independence of these patients3030 Loureiro HA, Silva KL, Braga MAF. A prática da terapia ocupacional junto ao idoso com alterações ortopédicas em um hospital de urgência e emergência. Rev Ter Ocup Univ São Paulo. 2019;30(1):53-61. Disponível em: https://doi.org/10.11606/issn.2238-6149.v30i1p53-61
https://doi.org/10.11606/issn.2238-6149....
.

The lowest level of agreement among the experts was 90% (for question 45). The first expert (nurse) in disagreement cited that the concepts described in this instrument did not rule out the possibilities of other key concepts, while the second expert (occupational therapist) was unable to expand on their reasoning for disagreement with this specific question. Among the 30 user judges, the lowest level of agreement was 93.3%, obtained for question numbers 27 and 45, reported by 2 users. One of the users cited that questions on post-stroke complications should have been included, while the other stated there should have been a question asking whether the patient had Parkinson´s disease. These suggestions were not incorporated into the final version of the COSMO because the aim of the study was to determine difficulties experienced by patients for performing functional mobility activities after surgery for hip fracture, irrespective of pre-existing health conditions. Thus, given the high level of agreement found in the study, no further adaptations to the final COSMO version were necessary.

To the best of our knowledge, the methodological procedures of this study allowed the development and content validation of the first Brazilian PROM-type instrument for functional assessment based on self-reporting of older adult inpatients after surgery for hip fracture in a hospital setting. The content validation process entailed critical examination of the basic structure of the instrument by patients as well as experts, based on a review of the procedures used for developing the questionnaire and of the applicability to the phenomenon of research interest3131 Venancio SI, Bortoli MC, Frias PG, Giugliani ER, Alves CRL, Santos MO. Development and validation of an instrument for monitoring child development indicators. J Pediatr (Rio J). 2020;96:778-789. Disponível em: https://doi.org/10.1016/j.jped.2019.10.008
https://doi.org/10.1016/j.jped.2019.10.0...
.

However, assessment of the reliability of the COSMO was not possible due to the dynamic of the hospital where patients were assessed. Typically, patients are discharged by the 2nd POD, largely to reduce the risk of nosocomial infections in the hospital environment. According to COSMIN guidelines1212 Terwee CB, Prinsen C, Chiarotto A, et al. COSMIN methodology for assessing the content validity of PROMs–user manual. Qual Life Res. 2018;27:1159–1170. Disponível em: https://doi.org/10.1007/s11136-018-1829-0
https://doi.org/10.1007/s11136-018-1829-...
,3232 Mokkink LB, Boers M, van der Vleuten C, et al. COSMIN Risk of Bias tool to assess the quality of studies on reliability and measurement error of outcome measurement instrument. BMC Med Res Methodol. 2020. Disponível em: https://doi.org/10.1186/s12874-020-01179-5
https://doi.org/10.1186/s12874-020-01179...
, the time interval between measurements should be sufficiently long to prevent memory bias regarding previous scores as they relate to intra-examiner reliability, yet sufficiently short so as to ensure patients do not present changes in the construct being measured3232 Mokkink LB, Boers M, van der Vleuten C, et al. COSMIN Risk of Bias tool to assess the quality of studies on reliability and measurement error of outcome measurement instrument. BMC Med Res Methodol. 2020. Disponível em: https://doi.org/10.1186/s12874-020-01179-5
https://doi.org/10.1186/s12874-020-01179...
. Consequently, the test of repeatability of data obtained by the COSMO was not possible because of the hospital discharge dynamic recommended for this type of patient. The second limitation of this study and, hence, of the COSMO tool, is that all PROM-type instruments require unimpaired cognitive functioning of participants1212 Terwee CB, Prinsen C, Chiarotto A, et al. COSMIN methodology for assessing the content validity of PROMs–user manual. Qual Life Res. 2018;27:1159–1170. Disponível em: https://doi.org/10.1007/s11136-018-1829-0
https://doi.org/10.1007/s11136-018-1829-...
. Therefore, application of COSMO should be limited to cognitively-healthy older adults.

This study was limited to verifying the content validity of the COSMO. Content validity assures the instrument is understandable and suitable for the target audience99 Terwee CB, Bot SD, de Boer MR, et al. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. Jan 2007;60(1):34-42. Disponível em: https://doi.org/10.1016/j.jclinepi.2006.03.012
https://doi.org/10.1016/j.jclinepi.2006....
. Thus, it is important to reiterate that content validation is a key step, for example, in studies of prognostic validity99 Terwee CB, Bot SD, de Boer MR, et al. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. Jan 2007;60(1):34-42. Disponível em: https://doi.org/10.1016/j.jclinepi.2006.03.012
https://doi.org/10.1016/j.jclinepi.2006....
. While content validation is fundamental, other measures for assessing the validity and reliability of the COSMO are now warranted.

CONCLUSION

The COSMO proved a relevant, comprehensive, understandable instrument with valid content for assessing functional mobility self-reported by older adult inpatients during the hospital stay after surgery for hip fracture. The functional mobility results obtained by COSMO can help inform decision-making by health professionals during hospital discharge of older adults after surgery for hip fracture, and also aid physical rehabilitation professionals in the hospital setting. A special feature of the COSMO is that it can be used to evaluate, in a composite cumulative manner, functional status before fracture and surgery, as well as physical-functional performance after surgery, taking account of the length of hospital stay pre and postoperatively.

ACKNOWLEDGMENTS

The authors extend their thanks to the University Hospital of the Universidade Federal do Vale do São Francisco (HU - UNIVASF), administrated by the Empresa Brasileira de Serviços Hospitalares (EBSERH), for providing the infrastructure and operational logistics required to conduct this study.

  • There was no funding for the execution of this work.
  • DATA AVAILABILITY

    The anonymized dataset underpinning the results of the present study are available on Figshare using the digital object identifier (DOI): https://doi.org/10.6084/m9.figshare.25726710.v2.

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    » https://doi.org/10.1186/s12874-020-01179-5

Edited by

Edited by: Larissa Neves Quadros

Data availability

The anonymized dataset underpinning the results of the present study are available on Figshare using the digital object identifier (DOI): https://doi.org/10.6084/m9.figshare.25726710.v2.

Publication Dates

  • Publication in this collection
    26 Aug 2024
  • Date of issue
    2024

History

  • Received
    11 Nov 2023
  • Accepted
    21 June 2024
Universidade do Estado do Rio Janeiro Rua São Francisco Xavier, 524 - Bloco F, 20559-900 Rio de Janeiro - RJ Brasil, Tel.: (55 21) 2334-0168 - Rio de Janeiro - RJ - Brazil
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