The effect of an occupation-based intervention in patients with hand-related disorders grouped using the sense of coherence scale: Study protocol

Abstract

Introduction

High-quality rehabilitation is required if patients with hand-related disorders are to achieve high levels of functioning. Occupation-based interventions are effective in stroke, hip fractures, and for elderly people, but there is limited knowledge of their effect in hand therapy. Sense of coherence may affect rehabilitation outcome, since patients with weak sense of coherence experience lower functioning, are less satisfied with their occupational performance, have inferior quality of life and more pain compared to patients with stronger sense of coherence .

Method

Following SPIRIT guidelines, we present a randomized, controlled, parallel-grouped trial. It investigates the effect of an occupation-based intervention for outpatients with hand-related disorders and whether sense of coherence influences the outcomes. Patients are stratified into three groups (weak, medium and strong sense of coherence) and randomized to occupation-based or exercise-based hand therapy. Sample size calculation indicates that 70 patients are required in each intervention in each separate sense of coherence group. With an expected drop-out of 20%, a total of 504 participants will be randomized. Primary analysis is score change in functioning measured by the Disabilities of the Arm, Shoulder and Hand from start of rehabilitation to three months’ follow-up. Secondary outcomes are self-evaluated occupational performance and satisfaction with occupational performance.

Conclusion

This study will add valuable knowledge to the field of hand therapy regarding the therapeutic use of occupations that patients find meaningful. Moreover, it may show which patients will benefit the most from an occupation-based intervention in relation to their sense of coherence.

Keywords

Hand therapy hand injury randomized controlled trial SOC-13 occupational performance

Introduction

Hand-related disorders are common and can have a significant impact on patients’ domestic, paid work and leisure activities.^1–3 High-quality rehabilitation is needed to achieve the highest possible level of functioning. Functioning is defined by the International Classification of Functioning, Disability and Health (ICF) as the outcome of a complex and dynamic interaction between the components body functions, activity, participation, environmental factors and personal factors.⁴ When the hands are used in daily occupations, some body functions are essential, such as range of motion, grip strength, dexterity and absence of pain that affect performance. However, these physical factors are poor predictors of the ability to perform daily occupations.^5–7 Physical exercises to increase range of motion and grip strength do not seem to be sufficient to enable a high level of functioning.⁵ Results from the existing literature support this by indicating that personal, social or environmental factors also have an impact on rehabilitation outcomes for hand-related disorders.^5,7,8 This supports the argument for an increased focus on further components from the ICF.

In Denmark, the majority of hand therapists are occupational therapists (OTs). The purpose of occupational therapy is to improve and enable patients’ occupational performance.⁹ Occupational performance is the dynamic interaction between a person, occupation and environment.⁹ Occupation-based interventions or activity-based interventions are very effective in stroke, hip fractures, and for elderly people.^10–13 The term occupation-based intervention refers to an intervention in which meaningful occupations are performed.¹⁴ In hand therapy, only a few studies have focused on occupation-based intervention and investigated their effect in intervention outcomes.¹⁵ Guzelkucuk et al.¹⁶ found that patients with hand-related disorders who undertook physical exercises combined with therapeutic activities that simulated daily occupations showed a significant increase in body function and functioning, compared with patients who undertook only physical exercises. However, more evidence is needed.¹⁵

In clinical settings, it is well known that patients with identical hand disorders who receive the same intervention sometimes recover very differently. Patients with severe hand injuries sometimes have better rehabilitation outcomes than patients with minor injuries. In ICF terms, this could be due to, among others things, personal factors, e.g. gender, age, race, lifestyle, education and coping styles, etc. To measure coping style, the sense of coherence (SOC) scale¹⁷ can be used. Antonovsky, who developed the theory of SOC, stated that a person’s ability to cope in a stressful situation such as crises, troubles or illness is reflected in their SOC.¹⁷ A strong SOC is characterized by the ability to continue to do well, both mentally and physically, in spite of stressful situations. SOC consists of three dimensions: comprehensibility, manageability and meaningfulness of one's life.^17,18 The theory is supported by research showing that a person’s SOC affects how a person deals with disease.^17,19 Patients with hand-related disorders and a weak SOC had a lower level of body function, were less satisfied with occupational performance, had inferior quality of life and more pain, compared with patients with a strong SOC.^2,20–22 Antonovsky developed a questionnaire to measure SOC that included 26 items¹⁷ and, later, a shortened version with 13 items (SOC-13).¹⁷

A randomized clinical trial has therefore been chosen to study the effect of occupation-based intervention for patients with hand-related disorders and to analyse if the level of SOC makes a difference to patients’ recovery.

The objective of this study is to investigate the effect of an occupation-based intervention on patients with hand-related disorders and to investigate whether the SOC-13 score can give an indication of the anticipated effects.

Hypotheses

Patients with hand-related disorders will benefit in functioning from an occupation-based intervention compared with an exercise-based intervention.

Patients with hand-related disorders and weak SOC-13 score (<52) achieve the best functioning, if their rehabilitation programme is occupation based.

Patients with hand-related disorders and medium SOC-13 scores (52–71) achieve the best functioning, if their rehabilitation programme is occupation based.

Patients with hand-related disorders and strong SOC-13 scores (72–91) will not benefit in functioning, if their rehabilitation programme is occupation based.

Methods

The study design is a randomized controlled, parallel-grouped trial, designed to identify the superiority of an occupation-based intervention in patients with hand-related disorders stratified by the SOC-13 scale. Randomization will be performed as block randomization with a balanced 1:1 allocation. This study protocol and subsequent trial reporting will adhere to the consolidated standards of reporting trials (CONSORT)²³ and the SPIRIT²⁴ guidelines.

Participants

The study will be carried out at the outpatient hand therapy clinic at Odense University Hospital in Denmark, from February 2014 to the end of 2016. Odense University Hospital has a highly specialized hand surgery department referring patients to the outpatient hand therapy clinic. In Denmark, patients with hand-related disorders can be referred to specialized outpatient hand therapy at a hospital or to general rehabilitation in the community.

Participants eligible for the study must comply with the following inclusion criteria at randomization: (i) diagnosed with a hand-related disorder (after acute injuries or elective surgeries), (ii) age ≥ 18, (iii) referred to specialist outpatient occupational therapy rehabilitation course, (iv) able to understand, speak and read Danish. Exclusion criteria: (i) shoulder disability (less than 100° of shoulder flexion), (ii) impaired extension in fifth finger of the non-dominant hand as the only disability, (iii) burn injury, (iv) epicondylitis, (v) operated ad modum Swanson in CMP-joints, (vi) hyper sensitivity of a scar as the only disability, (vii) not considered medically or therapeutically safe to allow the patient to be included in the randomization process, (viii) diagnosed with depression, dementia or cognitive impairments (orientation-memory-concentration test < 18), and, (ix) with no described or prioritized occupational performance problems. Patients with a rehabilitation period of fewer than four weeks or fewer than three intervention sessions, or a re-operation for the same disorder within a year will be excluded from the analyses after enrolment. Participants with a new injury in the hand will be excluded from the date of the new injury.

Enrolment will be consecutive at referral to rehabilitation at the outpatient hand therapy clinic. To make sure information about the study is given to all relevant patients by the hand surgeon, a reminder text message about the study will be sent on a daily basis, to all hand surgeons seeing outpatients in the hand clinic that day. Medical records of patients referred to the outpatient clinic will subsequently be checked to verify if patients who meet the eligibility criteria have been informed about the study. If not, information will be posted to the patient.

Intervention

Participants will be randomly assigned to receive an occupation based or a physical exercise-based intervention. The Canadian Taxonomic Code of Occupational Performance (TCOP)⁹ is used to describe the multiple levels of human occupational activities, and will clarify the differences in the study interventions. The definitions from TCOP are used to define occupation, activity, task and action. TCOP is hierarchically arranged and consists of five levels: at the lowest level are voluntary movements, then action, task, activity and occupation. Each level includes all the characteristics of the levels below.²⁵ Occupation is defined as an activity or set of activities that is given value and meaning by the patient.⁹ Furthermore, an activity is a set of tasks with a specific end point or outcome that is greater than the outcome of a single task.⁹ Even though TCOP is hierarchically arranged, it is not necessary to first practise voluntary movements before practising actions, etc. It is possible to achieve better voluntary movements by practising activities or occupations. Enabling occupational performance can be performed in all levels.²⁵ The experimental occupation-based intervention in this study consists of performance at all five levels of the TCOP. In the control group, i.e. the physical exercise-based intervention, only voluntary movements are performed. Both interventions are client-centred and goal-oriented and have a specific focus on enabling patients to participate in their everyday activities. In this study, a client-centred intervention concurs with the following definition:

Client-centred practice refers to collaborative approaches aimed at enabling occupation with clients who may be individuals, groups, agencies, governments, corporations or others. Occupational therapists demonstrate respect for clients, involve clients in decision-making, advocate with and for clients in meeting clients’ needs, and otherwise recognize clients’ experience and knowledge.²⁶

The goal-oriented approach is promoted using the Canadian Occupational Performance Measure (COPM),²⁷ in which patients identify occupational performance problems and these problems then become the goals of the interventions. In both interventions, comprehensibility, manageability and meaningfulness (SOC) will be incorporated in instructions about: risk factor modification, how to make everyday activities manageable and how to meet the challenges that arise because of the hand-related disorder.

Experimental intervention

In this study, the term occupation-based intervention refers to elements of the intervention in which meaningful occupations, activities or tasks are performed.

The term occupation-based intervention is inspired by Fisher.¹⁴ The intervention in this study is considered to be occupation based when the participants perform occupational skills training by conducting occupations, activities or tasks that they find meaningful and that they performed prior to their hand-related disorder. Secondly, compensatory and adaptive strategies learned while performing the activity or occupation are also occupation-based. An individual home exercise programme with 5–10 small occupations, activities or tasks will be individually designed by the participant and the OTs. Each activity or task is to be repeated 5–10 times; it should be challenging but achievable. The occupations, activities or tasks will be identified after a COPM interview. If technical aids are required to perform activities, patients will practise using the aids before they borrow them. The occupation-based intervention will be performed 33% of the time, both in the therapy setting and in the home exercise programme.

Communication and evaluation will be occupation focused, meaning that occupations are the objective and not the means to an end.¹⁴

In addition to the occupation-based and occupation-focused intervention, participants will also undertake physical exercises such as joint mobility and strength exercises, and desensitization and pain management appropriate for their disorder. In performing physical exercises, participants will be aware that the purpose is increased occupational performance. The participants will receive written instructions for both the physical exercise-based and occupation-based interventions (see Table 1).

Table 1.

Description of the interventions.

Intervention	Experimental intervention	Control intervention
Occupation-based intervention in specific meaningful occupations or activities, which they performed prior to their hand-related disorder	✓	−
Home exercise programme with 5–10 small occupations, activities or tasks is designed individually	✓	−
COPM interview	✓	✓
Occupation-focused communication and evaluation	✓	✓
Physical exercise-based intervention, such as joint mobility, strength exercises, desensitization and pain management appropriate to the disorder	✓	✓
Home exercise programme with physical exercises, such as joint mobility and strength exercises, etc. appropriate to the disorder	✓	✓
Before borrowing technical aids, practice their use to performing activities	✓	−
Possibility of borrowing technical aids	✓	✓

Control intervention

All participants in the control intervention will undergo a physical exercise-based intervention in accordance with usual standards of care and special needs. They will perform joint mobility exercises and strength exercises, desensitization and pain management, both in the therapy setting and as a home exercise programme. If necessary, they can also borrow technical aids, but without practising them in the clinic beforehand. All instructions will be given verbally and in writing. Communication and evaluation will be occupation focused (see Table 1).

The number of intervention sessions in both groups will be determined by the individual participants’ needs. Experienced OTs, who have pre-trial experience in delivering both occupation-based and physical exercise-based interventions to patients with hand-related injuries, will deliver both interventions. At each session, OTs and participants will discuss adherence to the intervention. Rehabilitation will end when the patient and the rehabilitation team (OT and hand surgeon) find that the patient is able to finish the rehabilitation on their own or when the recovery has reached a plateau.

In monitoring adherence to the experimental intervention, OTs will make entries in a diary after each session, to make sure each intervention is occupational based and at least one third of the intervention is occupation-based across three sessions. To determine the majority of activities to be performed at the outpatient hand therapy clinic, occupational performance problems experienced by 40 patients with hand-related disorders were ascertained before the study started, and the most frequent occupation, activity or task problems were made available for the interventions.

Primary outcome

Outcome measures will be gathered at baseline (FU-0), at one month follow-up (FU-1), at two months’ follow-up (FU-2), at three months’ follow-up (FU-3), at six months’ follow-up (FU-4) and at one year (FU-5) (Figure 1).

Figure 1.

CONSORT Flowchart.

The primary outcome is the score change in the self-administered Disabilities of the Arm, Shoulder and Hand (DASH)²⁸ questionnaire from baseline to three months. DASH is a relevant outcome measure because it monitors the functioning and symptoms associated with any condition in the upper extremity.²⁹ DASH consists of 30 items. Twenty-one items are about functioning, six items are about physical symptoms, and three are about social or role function. All items refer to the situation in the past week. The DASH questionnaire uses a five-point Likert scale, ranging from ‘no difficulty’ to ‘unable’, from ‘none’ to ‘extreme’ or from ‘no impact’ to ‘high impact’. The raw score will be converted to a score ranging from 1 to 100. One is interpreted as no disability and 100 as severe disability.²⁸ The DASH questionnaire is valid, reliable and responsive to all disabilities in the upper limb.^30,31 The Danish version of DASH is validated by Herup et al.,³¹ who found excellent reliability. A difference of 10 points in DASH scores is considered to be clinically relevant.³² DASH will be measured at FU-0 to FU-5 (see Figure 1 and Table 2).

Table 2.

Data collection.

	Baseline (FU-0)	1 month (FU-1)	2 months (FU-2)	3 months (FU-3)	6 months (FU-4)	12 months (FU-5)
DASH	✓	✓	✓	✓	✓	✓
EQ5D	✓			✓
SOC	✓			✓		✓
COPM	✓	✓	✓	✓
Overall occupational performance	✓	✓	✓	✓	✓	✓
Satisfaction with overall occupational performance	✓	✓	✓	✓	✓	✓
Satisfaction with occupational therapy		✓	✓	✓	✓	✓
Satisfaction with treatment effect		✓	✓	✓	✓	✓
Satisfaction with adherence		✓	✓	✓	✓	✓

COPM: Canadian Occupational Performance Measure; SOC: sense of coherence; DASH: disability of the arm, shoulder and hand.

Secondary outcomes

Subjective evaluation of current overall occupational performance and satisfaction with current overall occupational performance will be measured as score change. Satisfaction with occupational therapy intervention, treatment effect and adherence will be measured as a final value. These five elements are measured with five items – one item for each statement. The items have a 10-point numeric rating scale with an anchor at both ends, ranging from ‘not able to perform any daily activities at all’ to ‘able to do all daily activities extremely well’ and ‘not satisfied at all’ to ‘extremely satisfied’ for the subsequent four items. The items are custom-designed and inspired by the COPM.²⁷ They are tested in cognitive interviews before use in patients with hand-related disorders.^33,34 Subjective evaluation of current overall occupational performance and satisfaction with current overall occupational performance will be measured at FU-0 to FU-5 (Table 2). Satisfaction with occupational therapy intervention, treatment effect and adherence will be measured at FU-1 to FU-5 (Table 2).

Change in self-evaluation of specific occupational performance issues and satisfaction with current performance will be measured by the COPM.²⁷ The COPM is an individualized measure designed to detect change in the areas of self-care, productivity and leisure.²⁷ COPM contains a semi-structured interview. Participants have to define occupational performance problems and rate their importance on a numeric rating scale from 1 to 10, where 1 = ‘not important’ and 10 = ‘extremely important’.²⁷ It must relate to occupations they want to do, need to do or are expected to do. Then they have to select the three to five most important occupations of daily living, which are problematic to perform, due to their hand injury. Subsequently, they rate these occupations for performance and satisfaction with actual performance on a scale from 1 to 10, where 1 = ‘not able to do it at all’/‘not satisfied at all’ and 10 = ‘able to do it extremely well’/‘extremely satisfied’. Total performance and satisfaction scores are calculated individually by dividing the sum of the scores by the number of problems identified. Change in performance and satisfaction are measured by rescoring the prioritized problematic occupations. COPM is valid, reliable and responsive in a wide variety of samples,^35–38 including samples with patients with upper limb disorders.^39–42 To investigate differences in occupational performance between groups at different points in time, COPM will be measured at FU-0 and re-evaluated monthly until three months’ evaluation (FU-3) or for as long as they are treated at the outpatient clinic, if less than three months.

Health-related quality of life will be measured by the EQ-5D.^43,44 A health profile is given as categorical and continuous variable. EQ-5D^43,44 will be used to describe the three SOC groups at baseline and to investigate differences between the interventions from FU-0 to FU-3. EQ-5D is a standardized and generic, self-administered questionnaire developed by the EuroQol Group.^43,44 EQ-5D consists of two parts: a descriptive system and a visual analogue scale (EQ VAS). The EQ-5D descriptive system has five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has three levels: no problems, some problems, and severe problems.^43,44 The participant indicates the current state of his/her health by marking the most appropriate statement in each of the five dimensions. This becomes a one-digit number expressing the level selected for that dimension. The number for the five dimensions can be combined in a five-digit number describing the respondent’s health profile, e.g. 11111 would indicate full health. The health profiles can also be converted to a single EQ-5D index value between−0.59 and 1.0, with 1.0 corresponding to no health problems. This can be compared to the general population.^45,46 The EQ VAS records the participants’ self-rated health on a vertical, visual analogue scale from 0 to 100, where the endpoints are labelled ‘best imaginable health state’ (= 100) and ‘worst imaginable health state’ (= 0).⁴⁴ The reliability and validity of the EQ-5D have been shown in patients with an upper extremity disorder.⁴⁷ EQ-5D will be measured at baseline FU-0 and at three months (FU-3) (Table 2), to describe the population and investigate change in quality of life between follow-ups.

At baseline (FU-0), demographic data about age, gender, education, income and members of household will be obtained. To describe the population, the diagnosis, days since the injury or onset of symptoms and operation codes will be collected from medical records.

The Modified Hand Injury Severity Score (MHISS)⁴⁸ will classify the severity of the acute injuries. MHISS is a descriptive severity scoring system that quantifies injuries in the hand, wrist and forearm into four categories: minor <20, moderate 21–50, severe 51–100 and major >100.⁴⁸ The MHISS will be calculated retrospectively by the first author at enrolment using the patient’s admission notes and operation notes.

The SOC-13 questionnaire measures the SOC using a seven-point Likert scale. The score is summed into a total score ranging from 13 to 91 points. A high score is analogous to a strong SOC, indicating better coping capacity.¹⁷ The Danish SOC-13 was translated and validated in The Danish Longitudinal Health Behaviour Study.⁴⁹ SOC-13 is considered to be a valid and reliable tool to measure how people manage stressful situations and stay well.^50–52 In a study with patients with hand-related disorders, it has been found to be stable and reliable.⁵³ SOC-13 is reprinted and used with the permission of the copyright holders. SOC-13 will be completed at FU-0, FU-3 and FU-5, to measure stability of the SOC score during rehabilitation (Table 2).

Data collection

Baseline questionnaires will be handed out at the hand clinic or posted prior to the start of rehabilitation. The questionnaires will be completed on the first day of rehabilitation. As long as the participants receive rehabilitation, follow-up questionnaires will be completed at the clinic. Participants will complete the questionnaires by themselves and deliver them to the first author in sealed envelopes. After discharge, questionnaires will be posted to the participants with a stamped addressed envelope. Follow-up data will be collected (× months) ± 3 days from the enrolment date, e.g. FU-1 will be collected one month ± 3 days from the enrolment date. A reminder will be sent to the participant by mobile phone text message if the questionnaire is not returned within a week.

Participants excluded from the study after randomization because of a new operation or less than one month’s rehabilitation will be followed for drop-out analysis at FU-1, FU-3 and FU-5, if possible.

Sample size

A difference of 10 points in DASH scores between the experimental and the control intervention is deemed to be clinically relevant.³² Based on the literature, a standard deviation of 18 in the DASH score is estimated.⁵⁴ With a P = 0.0166 significance level and a power of 80%, a sample size of 70 patients for each group is necessary in each of the three SOC groups (weak, medium and strong). A 20% drop-out rate is expected; therefore, each of the six groups will contain 84 patients (in total 504 participants). Based on pre-examination of the population studied, 300 patients will meet the eligibility criteria annually, and it is estimated that 80% – approximately 240 patients – will be included per year.

Randomization

Enrolment and randomization will be conducted just before the start of rehabilitation by the first author or one of four OTs specially trained to enrol and assign participants to interventions. An OT will not enrol patients for whose care and treatment s/he will be responsible.

To ensure sufficient and balanced variation in patients in relation to pre-rehabilitation SOC, a balanced randomization principle has been implemented. In practice, patients will be balanced in six strata. Patients are blocked with group size of 10 in each strata. To ensure allocation, concealment allocation sequences are computer-generated in EpiData before project start by the first author and stored in sequentially numbered, sealed, invisible envelopes. The envelope will not be opened until the patient has given informed consent to participate and has completed the baseline questionnaires. This information will then be stored in a locked cabinet, to which only the first author has access.

Blinding

Because of the nature of the intervention, neither participants nor OTs can be blinded to allocation; however, they are blinded to SOC score. Because the questionnaires are self-administrated, outcome measurements are not blinded. The statistician will be blinded to group allocation.

Analysis

The DASH score change in the experimental occupation-based intervention will be compared with the DASH score change in the control physical exercise-based intervention for all primary analysis (hypotheses 1–4). We will use the chi-squared test for binary outcomes, Wilcoxon for ordinal outcomes and t-test for continuous outcomes in analysis of secondary outcomes. For subgroup analyses, we will use regression methods with appropriate interaction terms.

Reasons for withdrawal and exclusion for each randomization group will be compared qualitatively and by chi-squared tests.

P-values will be reported to four decimal places with P-values less than 0.001, reported as P < 0.001. Up-to-date versions of STATA will be used to conduct analyses. For all tests, we will use two-sided P-values with alpha 0.05 level of significance. When appropriate, the P-value will be adjusted by the Bonferroni method.

Data monitoring and data management

An interim analysis will be performed on the primary endpoint when 50% (=252) of the participants have been randomized and have completed FU-3. The study will end if a statistical significance of < 0.001 is found between interventions.

There will be double data entry in EpiData, with range check for all variables. The project is accepted by the Danish Data Protection Agency, Id.: 14/1845. Study-related information will be stored in accordance with the applicable rules.

Adverse events

No adverse events are expected in this study. Adverse events discovered during the study will be reported to the Danish Ethics Committee.

Auditing

OTs’ diaries will be audited continually, to review adherence to the interventions. The OTs will be instructed in use of the protocol bi-annually to ensure adherence. A detailed protocol manual will be drawn up, and all OTs will be regularly instructed in use of the manual.

Ethics and dissemination

The Regional Scientific Ethical Committee for Southern Denmark has approved this protocol, the informed consent forms and recruitment materials, Project-ID 20120123. The Ethical Committee has to approve any amendment prior to implementation.

Consent or assent

Qualified surgeons will introduce the study to patients at referral to rehabilitation for a hand-related disorder. The introduction to the study and explanation that they can withdraw without any consequences for their further treatment, approval and anonymity will be given both orally and in writing. Before enrolment, trained OTs will discuss the trial with patients in light of the information provided and obtain written consent from patients willing to participate. Patients not willing to participate will be asked to give written consent to allow the first author to make a medical records audit about injury severity and rehabilitation received. Participants are allowed to withdraw from the project at any time; they will then be offered a physical exercise-based intervention.

Access to data

Relevant primary data will be made available when main results are published.

Ancillary and post-trial care

None.

Dissemination policy

The trial will follow the CONSORT guidelines, for design, execution and reporting.²³ The results will be submitted to international rehabilitation peer-reviewed journals for publishing. Information about the results and implications for future rehabilitation will be posted to the participants.

Conclusions

This study will add valuable knowledge to the field of hand therapy regarding the therapeutic use of occupations from everyday life that patients find meaningful. Moreover, it may show which patients will benefit most from an occupation-based rehabilitation programme in relation to their SOC.

Footnotes

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work is supported by: the University of Southern Denmark, The Region of Southern Denmark, The Danish Occupational Therapist Association, Bevica Foundation and Odense University Hospital. Trial registration number: ClinicalTrials.gov: NCT02098564. Trial status: Recruiting. This funding source has no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results.

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