Studyprotocol Open Access

Download as pdf or txt
Download as pdf or txt
You are on page 1of 9

Serra et al.

BMC Public Health (2019) 19:348


https://doi.org/10.1186/s12889-019-6683-7

STUDY PROTOCOL Open Access

Prevention and management of


musculoskeletal pain in nursing staff by a
multifaceted intervention in the workplace:
design of a cluster randomized controlled
trial with effectiveness, process and
economic evaluation (INTEVAL_Spain)
Consol Serra1,2,3* , Mercè Soler-Font1,2, Ana María García4, Pilar Peña5, Sergio Vargas-Prada6,7
and José María Ramada1,2,3

Abstract
Background: Musculoskeletal pain (MSP) is the leading cause of years lived with disability. In consequence, to
reduce MSP and its associated sickness absence is a major challenge. Previous interventions have been developed
to reduce MSP and improve return to work of workers with MSP, but combined approaches and exhaustive
evaluation are needed. The objective of the INTEVAL_Spain project is to evaluate the effectiveness of a multifaceted
intervention in the workplace to prevent and manage MSP in nursing staff.
Methods: The study is designed as a two-armed cluster randomized controlled trial with a late intervention control group.
The hospital units are the clusters of randomization and participants are nurses and aides. An evidence-based multi-
component intervention was designed combining participatory ergonomics, case management and health promotion.
Both the intervention and the control groups receive occupational health care as usual. Data are collected at baseline, and
after six and 12 months. The primary outcomes are prevalence of MSP and incidence and duration of sickness absence due
to MSP. Secondary outcomes are work role functioning and organizational preventive culture. The intervention process will
be assessed through quantitative indicators of recruitment, context, reach, dose supplied, dose received, fidelity and
satisfaction, and qualitative approaches including discussion groups of participants and experts. The economic evaluation
will include cost-effectiveness and cost-utility, calculated from the societal and the National Health System perspectives.
Discussion: Workplace health programs are one of the best options for the prevention and control of non-communicable
diseases. The main feature of this study is its multifaceted, multidisciplinary and de-medicalized intervention, which
encompasses three evidence-based interventions and covers all three levels of prevention, which have not been previously
unified in a single intervention. Also, it includes a comprehensive quantitative and qualitative evaluation of the intervention
process, health results, and economic impact. This study could open the possibility of a new paradigm for the prevention
and management of MSP and associated sickness absence approach at the workplace.
(Continued on next page)

* Correspondence: [email protected]
1
Centre for Research in Occupational Health, Pompeu Fabra University/
IMIM-Hospital del Mar Medical Research Institute, PRBB-Barcelona Biomedical
Research Park. Dr. Aiguader, 88, 08003 Barcelona, Spain
2
CIBER of Epidemiology and Public Health, Barcelona, Spain
Full list of author information is available at the end of the article

© The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Serra et al. BMC Public Health (2019) 19:348 Page 2 of 9

(Continued from previous page)


Trial registration: Current Controlled Trials ISRCTN15780649 Retrospectively registered 13th July 2018.
Keywords: Musculoskeletal pain, Return to work, Cluster randomized controlled trial, Sick leave, Multifaceted intervention,
Ergonomics, Case management, Health promotion

Background company agents actively participate with the aims to


Musculoskeletal pain (MSP) and associated limitations identify and act over the determinants of MSDs [19, 20].
in mobility and functional capacity are essential charac- Participatory ergonomics programs have been tested in
teristics of musculoskeletal disorders (MSDs) [1]. Upper Spanish companies with promising results [21, 22].
extremity and low back are the most common pain loca- There is scientific evidence that the management of
tions. During the last two decades low back pain has musculoskeletal symptoms through a tailored approach
been the leading cause of years lived with disability, and could be more efficient if individuals are stratified ac-
its global prevalence and incidence still show an increas- cording to certain prognostic profiles in the initial stages
ing trend [2]. Healthcare workers are an occupational of the disorder and after treatment [23, 24]. At tertiary
group at high risk of developing MSP [3–5]. prevention, the available scientific evidence suggests that
In Europe, there is evidence that around 70–80% of case management can reduce the duration of sickness
workers report discomfort due to awkward postures and absence, musculoskeletal symptoms and disability, and
forceful work [2, 3] with an impact not only on health improve work continuity [25–27]. Integrating activities
but also on work and economy, representing 50% of on healthy lifestyles at work is also an important compo-
sickness absence episodes and 60% of permanent disabil- nent of occupational health programs to reduce MSP
ities [6]. This scenario generates new challenges on [28], so different strategies promoting workers’ physical
health systems, requiring new strategies for its preven- activity, emotional wellbeing and healthy diet [29–32]
tion and management [7, 8]. were also included. As for healthcare workers, promoting
International variations of the distribution of MSP in healthy lifestyles should be a priority because of its double
the population support that its onset and persistence are impact on their own health and that of patients, encour-
influenced by a complex and dynamic interaction aging these lifestyles within the general population. In
between biological, psychosocial, cultural and also indi- addition, the World Health Organization considers work-
vidual factors [9–11]. The biopsychosocial model simul- place as one of the best contexts for the prevention and
taneously considers all these factors and their impact on control of non-communicable diseases [33].
health and general well-being [12]. Although this model This paper presents the design of a study that evalu-
has become the dominant framework through which the ates the multifaceted INTEVAL_Spain intervention in
etiology and prognosis of MSDs is conceptualized, its the workplace in nursing staff from two tertiary hospitals
application into practice has not been optimal [13]. to prevent and manage MSP and its associated sickness
Traditionally, the causes of MSDs, and also MSP, have absence. We hypothesize that this intervention will be
been investigated through biomechanics, physiology, effective in terms of reducing the prevalence of MSP
genetics, epidemiology and rehabilitation, but separated and will also reduce the incidence of associated sickness
from other involved relevant disciplines [14]. This frag- absence and the time to return to work in the interven-
mented approach does not offer optimal management. tion group at the end of the study, compared to the con-
Evidence suggests that a combination of several specific trol non-intervention group. In addition, a process
approaches in multi-component interventions that ad- evaluation of the intervention and its association with
dress various determinants of the problem and those the impact on MSP, and an economic evaluation will be
that incorporate a workers’ participatory approach in the carried out.
intervention process can obtain better results [15–17].
The INTEVAL_Spain is an evidence-based interven- Methods
tion and consists of three components: participatory The CONSORT statement and the extension for cluster
ergonomics (primary prevention of occupational risk randomized trials were used to describe the design of
factors), case management (secondary and tertiary pre- the study [34, 35].
vention) and promotion of healthy lifestyles at work.
There is an increasing concern on the so-called partici- Study design and context
patory ergonomics programs because they are both The study is designed as a two-armed cluster random-
multi-factorial and participatory [18] and are defined as ized trial with a late intervention control group (Fig. 1)
interventions in the workplace in which the relevant where clusters are independent hospital units, and
Serra et al. BMC Public Health (2019) 19:348 Page 3 of 9

Fig. 1 Flowchart and overview of the trial

participants are nursing staff (nurses and aides) highly around 60% are nursing staff, and with an experienced
exposed to ergonomic risk factors at work. There is ex- in-house OHS each, that share common methodologies
tensive scientific evidence that incidence and prevalence and good coordination.
of MSP is very high and is the leading cause of sickness
absence in healthcare workers, especially nurses and Recruitment of companies
aides working in hospitals [36], as it is exposure to ergo- Hospitals had to meet the following criteria to guarantee
nomic and other risk factors [37, 38]. It is also well the selection of appropriate clusters and the implemen-
known that other non-occupational, cultural and individual tation of the intervention: (1) workforce of at least 500
factors also play an important role in the incidence and workers, (2) commitment and explicit interest from the
prognosis of MSP [36]. In Spain, as in other European hospital management to carry out the intervention and
countries, all employers are required to organize some kind its evaluation; (3) existence of an in-house OHS that
of occupational health service (OHS) according to exposure maintains routine quality records and is interested in de-
to occupational risks and company size. The tasks of these veloping the intervention and; (4) existence of work
OHS include traditional risk assessment and investigation units with exposure to significant musculoskeletal risks,
of occupational injuries, health surveillance mainly through as assessed by the OHS.
health examinations, prevention, training and information Based on these criteria, two tertiary hospitals with spe-
covering occupational and non-occupational health risks. cialized acute care, psychiatry, long-term and primary
External OHS are usually the main occupational health care were selected.
provider for small and medium size companies, whereas
large companies, including hospitals, usually have an in- Recruitment of participants
house OHS which offer better opportunities for research To recruit participants, informative sessions were per-
and testing new approaches to improve workers‘health. formed at each cluster before disclosing whether they
The study is conducted in two main tertiary hospitals would be allocated to the intervention or control group,
in the cities of Barcelona and Sabadell (Barcelona prov- and informed consent and the baseline questionnaires
ince) with similar level of health care complexity, a were obtained from each participant worker. After these
workforce of around 4000 workers each, of whom documents were filled in and returned, the units were
Serra et al. BMC Public Health (2019) 19:348 Page 4 of 9

randomized and informed about their condition of being Participant workers are voluntarily referred to case man-
intervention or control group, and the intervention agement either by themselves, by proposal of their
started. Follow-up questionnaires are administered at six supervisor or a physician of the OHS. Workers with a
and 12 months. The questionnaires are anonymous to serious underlying organic pathology are excluded from
promote participation and worker’s confidence towards this intervention component and managed according to
the intervention. Anonymized data related to sickness standard medical practice. A trained case manager as-
absence are collected for the period from 1 year before signs participants to three strata of management and
the intervention until the end of the study. treatment, according to their level of risk for persistent
musculoskeletal symptoms: low, medium or high. This
Eligibility criteria profile is obtained by telephone interview using a ques-
The inclusion criteria are nursing staff (nurses and tionnaire made of validated tools to generate a risk pro-
aides), including employees on sickness absence, who file and that assesses the presence of radiated pain,
voluntarily accept to participate. Workers with a tem- comorbidity, limitations to carry out daily activities,
poral contract during a short period, working in several discomfort derived from pain, fear of movement, beliefs
units and on sabbatical leave are excluded. and negative expectations regarding the prognosis of
pain, the presence of anxiety and of other mood disor-
Intervention ders [23, 24, 38, 40–43]. Workers assigned to the
The intervention covers the three levels of prevention low-risk group attend an education session on health be-
(primary, secondary and tertiary prevention), lasts for 1 liefs related to MSP. Workers assigned to the medium
year and is implemented to the control group thereafter. and high-risk groups receive specific and tailored treat-
For primary prevention of occupational risk factors, a ment including rehabilitation, physiotherapy and
standardized procedure of participatory ergonomics cognitive-behavioral therapy. In parallel, cases may be
named ERGOPAR, developed and previously piloted in discussed at the weekly clinical session with members of
Spain is used [39]. A working group (ERGO group) is the OHS to evaluate possible specific needs at work, as
organized for each hospital unit, including a specialist in job adjustments or improvements to help workers to
ergonomics, the unit supervisor/s, one referent worker stay and/or early return to work. The case manager con-
for each shift (morning, afternoon and two night shifts) tacts all workers regularly to carry out a motivational
and one workers’ union representative. This ERGO telephone follow-up, and also coordinates the services
group is responsible for the development and implemen- and plan the sessions.
tation of the intervention, and receive basic training in An evidence-based program to promote healthy life-
ergonomics and participatory methods. The intervention styles at work is also part of the intervention. This pro-
begins with the diagnostic phase, with the distribution of gram is addressed and offered to all nurses and aides of
a previously validated self-completed questionnaire in the participating intervention units, and application is
which data on MSP and exposure to musculoskeletal voluntary and free. It includes: (1) mindfulness training,
risk factors at work are collected using specific risk as- defined as a self-regulation approach to stress reduction
sessment. This information is then analyzed and dis- and emotional management [44], consisting of an
cussed by the ERGO group and a prioritized list of risk adapted course of 4 sessions of 2 h each on MBRS
factors is developed. The next step is the treatment (Mindfulness-based Stress Reduction) training which has
phase, in which the information collected in the ques- been shown to be effective in healthcare workers [29];
tionnaires is shared and discussed with coworkers in the (2) Nordic Walking training, defined as a walking tech-
so-called prevention circles. These circles propose a pri- nique that uses specially designed poles to actively in-
oritized list of preventive measures aimed to avoid or re- volve the upper body and arms with wide scientific
duce the identified ergonomic risk factors. This list may evidence of its benefits on various health outcomes, in-
include structural, technical, organizational, training cluding MSP and MSDs [30], offering a program of 12
and/or information measures for improvement, and sessions of 1.5 h/session during 12 weeks; and (3) healthy
workplace modifications. The OHS coordinates the im- eating based on the Mediterranean diet, as one of the
plementation of these measures along with the corre- healthiest dietary models that currently exist [31, 32]
sponding department managers. Based on the previous consisting on a 3 h session and a web platform.
available experience with the ERGOPAR method [22], Finally, all components of the intervention are inte-
the time required to complete all phases of the interven- grated and require coordination by a champion who acts
tion in each work unit has been estimated from six to as a leader and facilitator of the intervention, organising
12 months. and leading the work to be developed by the study team.
Secondary and tertiary prevention is carried out His/her tasks involve communication, meetings planning
through a tailored case management intervention. (i.e. informative sessions, and research team meetings),
Serra et al. BMC Public Health (2019) 19:348 Page 5 of 9

organization of the health promotion activities (i.e. cal- demands. The score of this questionnaire ranges from 0
endar planning), collection and data processing and writ- to 100, being 100 the maximum score (having 100% of
ing of reports. your functional capacity).

Occupational health care as usual Organizational preventive culture


During the intervention period, the OHS of each partici- Organizational preventive culture is measured by the In-
pating hospital keeps providing the standard occupa- stitute for Work & Health Organizational Performance
tional health practices for both the intervention and Metric (IWH-OPM) [50]. The IWH-OPM is an
control units. These practices include usual occupational evidence-based, eight-item questionnaire used to help
risk assessments, investigation of occupational injuries, organizations assess and improve their health and safety
health surveillance, smoking cessation, training, informa- performance and is measured at baseline, six and
tion and expert assessment in occupational health at all 12-month follow up.
levels in the hospital (i.e. managers, supervisors,
workers), as well as the usual support program for re- Process evaluation
turn to work mainly focused on interventions related to The intervention process will be evaluated based on
workplace adaptations, clinical support and management previous evidence and indicators for process evaluation
of permanent disability. [51, 52]: recruitment, context, reach, dose delivered,
dose received, fidelity and satisfaction. Additionally, the
Measurements and procedure stakeholder’s role will also be included (implementation
Data are collected by standardized, validated ques- strategy). Process evaluation data will be collected by
tionnaires, processed in registers and a sample was means of questionnaires, the champion registries and
double-checked to identify inconsistencies and errors. qualitative approaches (discussion groups with re-
Self-reported questionnaires are administered at base- searchers and participants). Recruitment, context and
line, six and 12-month follow-up. Details on process reach indicators will be available in the intervention and
evaluation are also stored in standardized registers, control group; dose delivered, dose received, fidelity and
and double-checked. Data of sickness absence will be satisfaction will only be available for the intervention
extracted from the company registries. group since these indicators refer to various aspects of
the intervention itself.
Primary outcomes Context information will be collected through discus-
Prevalence of musculoskeletal self-perceived pain sion groups and also, at six and 12-month follow-up
The Spanish adaptation of the Nordic Questionnaire with three questions related to the aspects that affect
from the ERGOPAR Method [45] is used to measure their usual workload (improvement in the manual
self-perceived MSP in the neck, shoulders and upper mobilization of patients, technical aids, and load hand-
back, low back, elbows, hands, legs, knees, and feet, ling). Recruitment, reach, dose delivered and dose re-
through the dichotomous question “Do you have dis- ceived, and fidelity (of the intervention and adherence of
comfort or pain in this area?”. Data are collected at base- the participants) data will be extracted from the cham-
line, six and 12-month follow-up. pion registers. Recruitment refers to the procedures used
to approach and attract prospective program partici-
Sickness absence pants, as defined as the proportion of possible workers
Data on episodes and duration of sickness absence due who agreed to participate in the study signing the in-
to a musculoskeletal condition (MSP or MSDs) are col- formed consent at baseline. Reach can be defined as the
lected from the company registries and the OHS during proportion of the intended target audience that partici-
the study period and 1 year before the intervention. pates in an intervention, according to the intervention
and control group reach and will be calculated consider-
Secondary outcomes ing the proportion of people who answered the ques-
Work functioning tionnaires from those who signed the informed consent.
Work functioning is measured at baseline, six and For each component of the intervention, reach will be
12-month follow-up using the Work Role Functioning calculated as the proportion of people who have partici-
Questionnaire-Spanish Version (WRFQ-SpV) [46–48]. pated in each one. Dose delivered will be calculated as
This tool is a self-administered questionnaire that mea- the number of hours of offered services, and dose
sures perceived difficulties in performing one’s job due received as the extent to which participants have actively
to health problems [49] and consists of 27 items divided participated in each component of the intervention. The
into five subdomains: work scheduling demands, output intervention and participants fidelity will also be
demands, physical demands, mental demands, and social assessed. We operatized the fidelity of the intervention
Serra et al. BMC Public Health (2019) 19:348 Page 6 of 9

as a ratio between the planned and the developed one, Data analysis
and the fidelity of the participants as adherence through Statistical analyses adapted for cluster-randomized con-
the proportion between their attendance and the dose trolled trials will be conducted. Descriptive analyses of
delivered. Questions on satisfaction are self-administered the participants’ characteristics and comparisons be-
at the end of each component of the intervention and at tween the intervention and control clusters will be per-
the 12-month follow-up questionnaire, through the formed. The generalized estimation equations (GEE)
questions “Have you met your expectations?” and “in procedure will be used for the analysis of the MSP, work
general, what is your satisfaction?” on a scale of 1 to 10, functioning and organizational preventive culture com-
being 10 the maximum satisfaction. Qualitative data paring the difference from the baseline to the 12-month
from the discussion groups will be used to identify the follow-up of the intervention group, with the difference
key points and the possible improvements, as the imple- from the baseline to the 12-month follow-up of the con-
mentation strategy indicator. trol group. The models will be adjusted by the cluster
design and by the potential confounders. The incidence
Economic evaluation of sickness absence will be analyzed through a logistic
A cost-utility and cost-effectiveness analysis will be regression model, taking as a reference the episodes
performed from the societal and the National Health started the year before the intervention and the control
System perspectives. The cost-utility analysis will be group. A Cox proportional hazard model will estimate
conducted to analyze changes in quality-adjusted life the hazard ratio of returning to work earlier after the
years (QALYs) measured by EQ-5D-3 L [41], and the intervention in the intervention group compared to the
corresponding costs for each perspective. Moreover, the control group.
cost-effectiveness analysis will compare changes in MSP Statistical analyses will be performed with STATA 13
to the costs for each perspective. The national health (StataCorp, 2013. Stata Statistical Software: Release 13.
system perspective will include the direct costs of the College Station, TX: StataCorp LP).
Spanish public health services (direct costs of the dis-
ease: visits to the GP, specialists, diagnostic tests and Statistical power
medication) and the costs of the intervention; the soci- The sample size estimation is based on the prevalence
etal perspective will include all these costs and also the MSP estimated at 80% for healthcare workers [3], the
loss of production (indirect costs). Direct costs will be impact of the intervention expecting a reduction of a
estimated based on administrative data from the clinical 20% in the prevalence of musculoskeletal pain [53, 54],
registers. Indirect costs will be estimated using the human alpha values (type I error) = 0.05, statistical power = 0.80
capital approach from sick leave (company registries). and interclass correlation coefficient (ICC) = 0.05. Apply-
Costs of the intervention (i.e. time of experts) will be ob- ing these criteria, we obtained a minimum sample of
tained from the study register and will become unit costs 164 subjects, 82 in each group. The units of the partici-
according to the corresponding collective agreements. pating hospitals have a varied number of workers (20 to
60). Taking into account the sample size calculations, 8
Randomization units have been randomized.
Nursing staff (nurses and aides) of the hospital units
with higher exposure to musculoskeletal risk due to Discussion
ergonomic risk factors at the hospital unit and the type A multifaceted intervention on MSP in hospital nursing
of patients (medium and high dependency) are selected. and aide staff has been designed and described. The im-
An independent researcher assigns the clusters to the pact on MSP in the population shows that this is one of
intervention group or to the control group by simple the main health challenges that must be addressed in
randomization stratified by center. Spain and similar countries in terms of health, work and
economy [2, 3, 6].
Blinding
In this cluster randomized trial blinding was not pos- Methodological considerations
sible. The condition of being included in the interven- The randomized controlled trial (RCT) is the basic
tion or the control group cannot be blinded but the methodological paradigm for the evaluation of health
clusters are randomized after signing informed consent interventions. Randomization guarantees that the assign-
and completing the baseline questionnaire. The services ment of a work unit to the intervention or control group
provided and the participating OHS professionals cannot is exclusively due to chance, thus avoiding effects of
be blinded because they are involved in the implementa- confounding and selection biases. The availability of a
tion of the intervention. control group makes it possible to distinguish between
Serra et al. BMC Public Health (2019) 19:348 Page 7 of 9

epidemiological and/or statistical associations and occupational health specialists, taking advantage of the
cause-effect relations. strengths and potentials of each of these agents and is
The INTEVAL_Spain has some strengths that make it carried out in close collaboration between the participat-
unique in occupational health. First, it is a multifaceted ing companies. This condition is both an opportunity
intervention that includes the three preventive levels and a challenge. An opportunity, since the direct inter-
(primary, secondary, tertiary) simultaneously to reduce action with the company’s agents in the development of
MSP in workers. Secondly, it has a multidisciplinary, the research strengthens the relationships among re-
de-medicalized and participatory approach, as it requires search centers, researchers themselves and the company,
the involvement of the main agents in the company and facilitates the transfer of results to their direct users
(managers, workers, technicians). And third, this study and targets. It is also a common challenge in occupa-
places special emphasis on the evaluation of results, tional health intervention studies, as it is necessary to
process, and economics, and uses quantitative and quali- achieve the adjustment between the methodological re-
tative methods for collecting data to achieve a compre- quirements of the research and times, expectations and
hensive and accurate assessment at all levels of the needs of the productive activity in the company.
intervention. In addition, this study places special em- This study aims to promote a change of orientation
phasis on the evaluation of results, process and econom- and a new paradigm for the prevention and management
ics, and consists of mixed methods of collecting data of MSP and associated sickness absence. The idea of
(qualitative and quantitative) to achieve a comprehensive implementing these combined and non-medicalized in-
and accurate assessment at all levels of the intervention. terventions in the OHS in a sustainable way over time
Our study has also potential limitations that we need could facilitate access for an early management of MSP
to consider. There may be a participation bias, since at work, improve their health and be cost-effective.
workers with MSP could be more interested in partici-
pating, and otherwise, workers with good health could Abbreviations
not feel the need of participating. Therefore, a sensitivity MSDs: Musculoskeletal disorders; MSP: Musculoskeletal pain;
analysis comparing the sociodemographic variables of OHS: Occupational Health Service
the participants and non-participants of each cluster will
be carried out in order to quantify it. Moreover, there Acknowledgements
could be contamination, which could result in an under- We want to thank all healthcare workers and their representatives, referents,
managers and supervisors from the hospital clusters of Parc de Salut Mar
estimation of the effectiveness. However, clusters are dif- (PSMar) and Corporació Sanitaria Parc Taulí (CSPT) who agreed to participate
ferent units located in different buildings and/or in the trial. Especially, PSMar: Pilar Pastor (Ward manager), Isabel Aranega,
different floors, and therefore may not have much con- Noemí Cajete, Raúl Martín, Dolores Rincón, Nuria Saavedra (UH30); Rosa
Balaguer (ward manager), Sonia Advíncula, Nuria Esteban, Montse Regordosa,
tact between them. Also, as it is a specific population Cristina Salvat, Ana Uribe (Intensive Care Unit); Isabel Egea (ward manager),
(nurses and aides of public hospitals), the external valid- Ana Delgado, M Ángeles Fernández, Josefa García, Susana Margalef,
ity of the results concerning the working population Alexandra Morales, Ana M Rodríguez, Isabel Rodríguez (Llevants 3,4); Montse
Sitges, Txell Gumà (ward managers), Rosa Elias, Lucía Fernández, Ana M
may be limited. Finally, questionnaires are anonymous Luque, Nuria Morillas, Carlos Perez, Sandra Vives (Surgical area); Elena Maull,
and an identifier is not available. The research team Desirée Ruiz (ward manager), Alberto Gonzalez, Antonia Rincón, Bernat
made this decision to encourage participation and make Sarrió, Gina Shakya (UH04); Beatriz Fernández (ward manager), Mª
Encarnación Avilés, Miriam Hernández, Naza Martinez, Carme Pellín, Nenita
sure that participants were feeling comfortable with the de los Santos, Sergio Taibo, Chari Villanueva (Acute geriatrics unit). Rosa
study, since the questionnaires were self-completed in Aceña, Cuca Esperanza and Núria Pujolar (Nursing Coordinators); Mercedes
the workplace and included some personal questions, as Calvo, Miguel Celada, Lluisa Cosp, Eugenio Gurrea, Montse Sallés, Pilar
Serrano (Nurse Supervisors); and Vicky Abad, Pilar González, Francisco Martos
well as questions about the relationship with the super- (Prevention Delegates). CSPT: Isabel Simó (ward manager), Mª Goretti
visors. However, we are aware that this decision could Gelonch, Elisabeth Mérida, Sara Purcalla, Mónica Sianes (UH06); José Mª
limit the statistical power and entail an underestimation Barradas (ward manager), Judith Camps, M José González, Verònica Gómez,
Victoria Plaza, Estefanía del Pino (UH08); and Elena Polo (Prevention
of the results. Delegate).
We also want to thank the contribution of Toni Merelles (University of
Possible impact of results Valencia) for taking the lead of the funding coordination, Chelo Sancho
(specialist in participatory ergonomics), Rocío Villar (occupational physician,
The preventive intervention evaluated in the INTE- PSMar); Victòria Lopez (occupational nurse, CSPT); Cristina Cervantes, Ferran
VAL_Spain project is characterized by its flexibility, effi- Escalada and the physiotherapists team (Rehabilitation Service, PSMar);
ciency and capacity to adapt to different companies’ Fernanda Caballero and physiotherapists team (Rehabilitation Service, CSPT);
Gemma Salvador (Agència de Salut Pública de Catalunya) and Ada Parellada
needs. In addition, it is designed to optimize and make (Chef); Anna Amat (champion and case manager), Carmen de la Flor
most of existing prevention resources in companies (champion), Montserrat Fernandez (CiSAL, UPF); Cristina Giménez
cost-effective. The whole project, in fact, is based on the (Psychologist); Antonio Brieba (Nordic walking instructor); Georgina Badosa
and Mónica Astals (Mindfulness instructors).
sum of capacities of the different participants: managers, We would like to acknowledge Mireya Jaramillo for providing a grammatical
workers and their representatives, researchers, and revision of the text.
Serra et al. BMC Public Health (2019) 19:348 Page 8 of 9

Funding and carrying among female healthcare workers. Int Arch Occup Environ
The study is funded by the Instituto de Salud Carlos III-FEDER (reference Health. 2013;86–4:463–70.
numbers PI14/01959, December 2014; and PI17/00779, October 2017) and 5. Wang S, Liu L, Lu M, Koo M. Comparisons of musculoskeletal disorders
Fundación Prevent (December 2016). The funders had no role in the study among ten different medical professions in Taiwan: a nationwide,
design, data collection and analysis, decision to publish, or preparation of population-based study. PLos One. 2015;10–4:1–10.
the manuscript. 6. Okunribido O, Wynn T. Aging and work-related musculoskeletal disorders: a
review of the recent literature. Norwich: Health and Safety Executive; 2010.
Availability of data and materials p. RR799.
Data sharing is limited to the study research team and all analyses will be 7. Murray CJL, Vos T, Lozano R, et al. Disability-adjusted life years (DALYs) for
carried out internally. 291 diseases and injuries in 21 regions, 1990-2010: a systematic analysis for
the global burden of disease study 2010. Lancet. 2012;380:2197–223.
Authors’ contributions 8. Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, et al. Years
CS is the current project leader, co-author of the original version of the lived with disability (YLDs) for 1160 squealed of 289 diseases and injuries
protocol for the provision of funding, is the field work coordinator of Parc de 1990–2010: a systematic analysis for the Global Burden of Disease Study
Salut Mar (Barcelona) and co-drafted the manuscript. MS contributed to the 2010. Lancet. 2012;380–9859:2163–96.
study design and measurements, and drafted the first version of this manu- 9. National Research Council. Steering Committee for the Workshop on Work-
script. AMG wrote the original version of the protocol for the provision of Related Musculoskeletal Injuries. Work-Related Musculoskeletal Disorders:
funding as a project leader, and contributed to the manuscript. PP is the field Report, Workshop Summary, and Workshop Papers. Washington: National
work coordinator of Corporació Parc Taulí (Sabadell), participated in the de- Academy Press; 1999.
sign and implementation of the study and contributed to the manuscript. 10. Coggon D, Ntani G, Vargas-Prada S, Martinez JM, Serra C, Benavides FG,
SVP randomized the clusters, contributed to the planning of different scales Palmer KT. Members of CUPID Collaboration International variation in
for the diverse outcome measurements, and contributed to the manuscript. absence from work attributed to musculoskeletal illness: findings from the
JMR participated in the design, planning and implementation of the study, CUPID study. Occup Environ Med. 2013;70:575–84.
and contributed to the manuscript. All authors have read and approved the 11. Bernal D, Campos-Serna J, Tobias A, Vargas-Prada S, Benavides FG, Serra C.
final version. Work-related psychosocial risk factors and musculoskeletal disorders in
hospital nurses and nursing aides: A systematic review and meta-analysis.
Ethics approval and consent to participate Int J Nurs Stud. 2015;52:635–48.
Ethical approval was obtained from the Clinical Research Ethical Committee 12. Engel G. The need for a new medical model: a challenge for biomedicine.
of the Parc de Salut Mar, reference number: 2014/5714/1. Informed written Science. 1977;196–4286:129–36.
consent is obtained from all participants. The written and oral information 13. Carnes D, Homer K, Underwood M, Pincus T, Rahman A, Taylor S. Pain
that given to the participants, stresses that their participation is voluntary management for chronic musculoskeletal conditions: the development of
and that they may withdraw at any time without having to give a reason. an evidence-based and theory-informed pain self-management course. BMJ
Open. 2013;3–11:e003534.
Consent for publication 14. Marras WS. State-of-the-art research perspectives on musculoskeletal
Not applicable. disorder causation and control: the need for an intergraded understanding
of risk. J Electromyogr Kinesiol. 2004;14–1:1–5.
Competing interests 15. Hoefsmit N, Houkes I, Nijhuis FJ. Intervention characteristics that facilitate
The authors declare that they have no competing interests. return to work after sickness absence: a systematic literature review.
J Occup Rehabil. 2012;22–4:462–77.
16. Cullen KL, Irvin E, Collie A, Clay F, Gensby U, Jennings PA, et al. Effectiveness
Publisher’s Note of workplace interventions in return-to-work for musculoskeletal, pain-
Springer Nature remains neutral with regard to jurisdictional claims in related and mental health conditions: an update of the evidence and
published maps and institutional affiliations. messages for practitioners. J Occup Rehabil. 2018;28–1:1–15.
17. Rasmussen CDN, Holtermann A, Bay H, Sogaard K, Jorgensen MB. A multi-
Author details faceted workplace intervention for low back pain in nurses’ aides: a pragmatic
1 stepped wedge cluster randomised controlled trial. Pain. 2015;156:1786–94.
Centre for Research in Occupational Health, Pompeu Fabra University/
IMIM-Hospital del Mar Medical Research Institute, PRBB-Barcelona Biomedical 18. Silverstein B, Clark R. Interventions to reduce work-related musculoskeletal
Research Park. Dr. Aiguader, 88, 08003 Barcelona, Spain. 2CIBER of disorders. J Electromyogr Kinesiol. 2004;14:135–52.
Epidemiology and Public Health, Barcelona, Spain. 3Occupational Health 19. Van Eerd D, Cole D, Irvin E, Mahood Q, Keown K, Theberge N, et al. Process
Service, Parc de Salut Mar, Barcelona, Spain. 4Department of Public Health, and implementation of participatory ergonomic interventions: a systematic
University of Valencia, Valencia, Spain. 5Occupational Health Service, review. Ergonomics. 2010;53–10:1153–66.
Corporació Sanitària Parc Taulí, Sabadell, Spain. 6Healthy Working Lives 20. García AM, Gadea R, Sevilla MJ, Genís S, Ronda E. Participatory ergonomics:
Group, Institute of Health and Wellbeing, College of Medical, Veterinary and a model for the prevention of occupational musculoskeletal disorders. Rev
Life Sciences, University of Glasgow, Glasgow, UK. 7Salus Occupational Esp Salud Pública. 2009;83:509–18.
Health, Safety and Return to Work Services, NHS Lanarkshire, Hamilton, UK. 21. García AM, Sevilla MJ, Gadea R, Casañ C. Intervención de ergonomía
participativa en una empresa del sector químico. Gac Sanit. 2012;26–4:383–6.
Received: 14 December 2018 Accepted: 20 March 2019 22. García AM, Boix P, Benavides FG, Gadea R, Rodrigo F, Serra C. Participación
para mejorar las condiciones de trabajo: evidencias y experiencias. Gac
Sanit. 2016;30-S1:87–92.
References 23. Hill JC, Dunn KM, Lewis M, Mullis R, Main CJ, Foster NE, Hay EM. A Primary
1. World Health Organization. Occupational health. Musculoskeletal conditions. Care Back Pain Screening Tool: Identifying Patient Subgroups for Initial
WHO. 2018. http://www.who.int/mediacentre/factsheets/musculoskeletal/en. Treatment. Arthritis Rheum. 2008;59–5:632–41.
Accessed 1 May 2018. 24. Hill JC, Whitehurst DGT, Lewis M, Bryan S, Dunn KM, Foster NE, et al. Comparison
2. GBD 2016. Disease and Injury Incidence and Prevalence Collaborators. of stratified primary care management for low Back pain with current best
Lancet. 2017;390:1211–59. practice (STarT Back): a randomized controlled trial. Lancet. 2011;378:1560–71.
3. Pinilla García J, Almodóvar Molina A, Galiana Blanco ML, Hervás Rivero P, 25. Demou E, Gibson I, Macdonald EB. Identification of the factors associated
Zimmermann Verdejo M. Encuesta Nacional de Condiciones de Trabajo. with outcomes in a condition management Programme. BMC Public Health.
2015 6ª EWCS – España. Madrid (Spain): Instituto Nacional de Seguridad e 2012;12:927.
Higiene en el Trabajo; 2017. 26. Kamper SJ, Apeldoorn AT, Chiarotto A, Smeets RJ, Ostelo RW, Guzman J,
4. Holtermann A, Clausen T, Aust B, Mortensen OS, Andersen LL. Risk for low et al. Multidisciplinary biopsychosocial rehabilitation for chronic low back
back pain from diferent frequencies, load mass and trunk postures of lifting pain. Cochrane Database Syst Rev. 2014;9:CD000963.
Serra et al. BMC Public Health (2019) 19:348 Page 9 of 9

27. Brown J, Mackay D, Demou E, Craig J, Frank J, Macdonald EB. The EASY 49. Amick BC III, Lerner D, Rogers WH, Rooney T, Katz JN. A review of health-
(Early Access to Support for You) sickness absence service: a four-year related work outcome measures and their uses, and recommended
evaluation of the impact on absenteeism. Scand J Work Environ Health. measures. Spine. 2000;25:3152–60.
2015;41–2:204–15. 50. Organizational Indices Committee of the Occupational Health and Safety
28. The National Institute of Occupational Safety and Health (NIOSH). NIOSH Council of Ontario. Benchmarking organizational leading indicators for the
Total Worker Health. Webinar Series. https://www.cdc.gov/niosh/twh/. prevention and management of injuries and illnesses. Toronto: Institute for
Accessed 21 Mar 2018. Work & Health; 2011.
29. Zeller JM, Levin PF. Mindfulness interventions to reduce stress among 51. Linnan L, Steckler A. Process evaluation for public health interventions and
nursing personnel: An occupational health perspective. Workplace Health research. An overview. San Francisco: Jossey-bass; 2002.
Saf. 2013;61–2:85–9. 52. Wierenga D, Engbers LH, van Empelen P, Hildebrandt VH. The design of a
30. Tschentscher M, Niederseer D, Niebauer J. Health benefits of Nordic real-time formative evaluation of the implementation process of lifestyle
Walking: a systematic review. Am J Prev Med. 2013;44–1:76–84. interventions at two worksites using a 7-step strategy (BRAVO@work). BMC
31. Martínez-González MA, Corella D, Salas-Salvadó J, Ros E, Covas MI, Fiol M Public Health. 2012;12:619.
et al. Cohort Profile: design and methods of the PREDIMED study. Int J 53. Best ML. An ecology of text: using text retrieval to study a life on the net.
Epidemiol. 2012;41–2:377–85. Artif Life. 1997;3–4:261–87.
32. Saulle R, Semyonov L, La Torre G. Cost and cost-effectiveness of the 54. Evanoff BA, Bohr PC, Wolf LD. Effects of a participatory ergonomics team
Mediterranean diet: results of a systematic review. Nutrients. 2013;5–11: among hospital orderlies. Am J Ind Med. 1999;35–4:358–65.
4566–86.
33. World Health Organization. Occupational health. Workplace health
promotion. 2018. http://www.who.int/occupational_health/topics/
workplace/en/. Accessed 1 Oct 2018.
34. Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gotzsche
PC, Lang T. The revised CONSORT statement for reporting randomized trials:
explanation and elaboration. Ann Intern Med. 2001;134:663–94.
35. Campbell MK, Piaggio G, Elbourne DR, Altman DG. Consort 2010 statement:
extension to cluster randomised trials. BMJ. 2012;345:e5661.
36. Vargas-Prada S, Serra C, Martínez JM, Ntani G, Delclos GL, Palmer KT,
Coggon D, Benavides FG. Psychological and culturally-influenced risk factors
for the incidence and persistence of low back pain and associated disability
in Spanish workers: findings from the CUPID study. Occup Environ Med.
2013;70:57–62.
37. Occupational health and safety risks in the healthcare sector. Guide to
prevention and good practice. Luxembourg: European Union. 2011. file:///
C:/Users/U10052/Downloads/New-EUL14157_Healthcare_Sector_web.pdf.
Accessed 10 Sept 2018.
38. Vargas-Prada S, Martínez JM, Coggon D, Delclos G, Benavides FG, Serra C.
Health beliefs, low mood, and somatizing tendency: contribution to
incidence and persistence of musculoskeletal pain with and without
reported disability. Scand J Work Environ Health. 2013;39:589–98.
39. Gadea R, Sevilla M, García A. ERGOPAR 2.0. Un procedimiento de ergonomía
participativa para la prevención de trastornos musculoesqueléticos de
origen laboral. Madrid: Instituto Sindical de Trabajo, Ambiente y Salud
(ISTAS); 2014.
40. Sánchez-López P, Dresch V. The 12-Item General Health Questionnaire
(GHQ-12): reliability, external validity and factor structure in the Spanish
population. Psicothema. 2008;20–4:839–43.
41. Williams A. EQ-5D concepts and methods. Eds. Kind P, Brooks R, Rabin R.
Dordrecht: Springer. 2005:1–17.
42. Schwarzer R, Jerusalem M. Generalized Self-Efficacy scale. In: Weinman J,
Wright S, Johnston M, editors. Measures in health psychology: A user’s
portfolio. Causal and control beliefs. Windsor: NFER-NELSON; 1995. p. 35–7.
43. Bayliss EA, Ellis JL, Steiner JF. Seniors’ self-reported multimorbidity captured
biopsychosocial factors not incorporated into two other data-based
morbidity measures. J Clin Epidemiol. 2009;62–5:550–7.
44. Bishop SR. What do we really know about mindfulness-based stress
reduction? Psychosom Med. 2002;64:71–84.
45. García AM, Gadea R, Sevilla MJ, Ronda E. Validación de un cuestionario para
identificar daños y exposición a riesgos ergonómicos en el trabajo. Rev Esp
Salud Pública. 2011;85:331–40.
46. Ramada JM, Serra C, Amick BC III, Castano JR, Delclos GL. Cross-Cultural
Adaptation of the Work Role Functioning Questionnaire to Spanish Spoken
in Spain. J Occup Rehabil. 2013;23–4:566–75.
47. Ramada JM, Serra C, Amick BC III, Abma FI, Castano JR, Pidemunt G, et al.
Reliability and Validity of the Work Role Functioning Questionnaire (Spanish
Version). J Occup Rehabil. 2014;24–4:640–9.
48. Ramada JM, Delclos GL, Amick BC III, Abma FI, Pidemunt G, Castano JR,
et al. Responsiveness of the Work Role Functioning Questionnaire (Spanish
Version) in a General Working Population. J Occup Environ Med. 2014;56–2:
189–94.

You might also like