Translation and Validation of the Shoulder Instability Return to Sports Index (SIRSI) and Tampa Scale of Kinesiophobia Shoulder Instability (TSK-SI) Into German
Phase: NA
Conditions: Shoulder Instability
Sponsor: Schulthess Klinik

 
Project plan template 
Human research other than clinical trials 
 
v2.5, 31.08.2022 
Translation and validation of the Shoulder Instability Return to Sports 
Index (SIRSI) and Tampa Scale of Kinesiophobia Shoulder Instability 
(TSK-SI) into German 
 
 
 
Study Type: 
Other Clinical Trial according to ClinO, Chapter 4  
 
Risk Categorisation:  
A 
 
Study Registration: 
 
clinicaltrials.gov 
 
 
 
 
SNCTP 
 
Sponsor: 
 
 
Schulthess Klinik Zürich  
 
 
 
 
Lengghalde 2 
 
 
 
 
8008 Zürich 
 
Prinicpal Investigator: 
Dr. Asimina Lazaridou, PhD 
Head of Research Group Upper Extremities and Hand 
Teaching, Research & Development  
Lengghalde 2 
8008 Zürich 
+41 44 385 79 77 
Asimina.lazaridou@kws.ch 
 
Investigated Intervention:  
Usage of the Shoulder Instability Return to Sports Index and 
Tampa Scale of Kinesiophobia Shoulder Instability Questionnaire 
 
Protocol ID:  
OE-236 SIRSI Validation 
 
Version and Date: 
Version 2 (dated 09/07/2024) 
 
Confidentiality Statement:   
 
The information contained in this document is confidential and the property of the sponsor. The 
information may not be transmitted, reproduced, published, or disclosed to others than the 
applicable Competent Ethics Committee and Regulatory Authorities without prior written 
authorisation from the sponsor except to the extent necessary to obtain informed consent from 
those who will participate in the study. 
 
 

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PROTOCOL SIGNATURE FORM    
 
Study Title 
Translation and validation of the Shoulder Instability Return 
to Sports Index (SIRSI) and Tampa Scale of Kinesiophobia 
Shoulder Instability (TSK-SI) into German 
 
The project leader has approved the protocol version 02 (dated 09.07.2024) and confirms hereby 
to conduct the project according to the protocol, the Swiss legal requirements (Bundesrat, 2013; 
Eidgenossenschaft, 2011), current version of the World Medical Association Declaration of 
Helsinki (World-Medical-Association, 2018) and the principles and procedures for integrity in 
scientific research involving human beings.  
 
Principal Investigator: 
 
Site: Schulthess Klinik Zürich, Lengghalde 2, 8008 Zürich 
 
Name: Dr. Asimina Lazaridou, PhD 
 
Date: 
 _________________________ 
Signature:  ___________________________  
 
 
 
 
Sponsor: 
 
Site: Schulthess Klinik Zürich, Lengghalde 2, 8008 Zürich 
 
 
 

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TABLE OF CONTENTS 
TABLE OF CONTENTS 
3 
GLOSSARY OF ABBREVATIONS 
5 
1 STUDY SYNOPSIS 
6 
2 BACKGROUND AND PROJECT RATIONALE 
9 
3 PROJECT OBJECTIVES AND DESIGN 
9 
3.1 
Primary objective 
9 
3.2 
Primary endpoints 
9 
3.3 
Secondary endpoints 
10 
3.4 
Study Design 
10 
4 PROJECT POPULATION AND STUDY PROCEDURES 
10 
4.1 
Project population 
10 
4.2 
Inclusion criteria 
11 
4.3 
Exclusion criteria 
11 
4.4 
Sample Size 
11 
4.5 
Recruitment, screening and informed consent procedure 
12 
4.6 
Study procedures 
12 
4.7 
Withdrawal and discontinuation 
12 
5 STATISTICS AND METHODOLOGY 
13 
5.1 
Translation plan 
13 
5.2 
Statistical analysis plan 
13 
5.3 
Handling of missing data 
14 
5.4 
Statistical quality considerations 
14 
6 REGULATORY ASPECTS AND SAFETY 
14 
6.1 
Local regulations / Declaration of Helsinki 
14 
6.2 
(Serious) Adverse Events and notification of safety and protective measures 
14 
6.2.1 
Reporting of SAEs (see ClinO, Art. 63) 
15 
6.2.2 
Follow up of (Serious) Adverse Events 
16 
6.2.3 
Notification of safety and protective measures (see ClinO, Art 62, b) 
16 
6.3 
(Periodic) safety reporting 
16 
6.4 
Radiation 
16 
6.5 
Amendments 
16 
6.6 
Notification and reporting upon completion, discontinuation or interruption of the 
study 
16 
6.7 
Insurance 
17 
7 FURTHER ASPECTS 
17 
7.1 
Overall ethical considerations 
17 
7.2 
Risk-Benefit Assessment 
17 
7.3 
Rationale for the inclusion of vulnerable participants 
18 
8 QUALITY CONTROL AND DATA PROTECTION 
18 
8.1 
Quality measures 
18 
8.2 
Data recording and source data 
18 
8.3 
Electronic Data Capture system 
18 
8.4 
Data recording 
18 

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8.5 
Confidentiality and coding 
19 
8.6 
Retention and destruction of project data  
19 
9 FUNDING / PUBLICATION / DECLARATION OF INTEREST 
19 
9.1 
Publication policy 
19 
9.2 
Conflict of interest 
19 
REFERENCES 
20 
10 APPENDIX 
21 
10.1 Appendix 1: Invitation Email 
21 
 
 

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GLOSSARY OF ABBREVATIONS 
 
ACL-RSI 
Anterior Cruciate Ligament – Return to Sports Index 
ADL 
 
Activities of Daily Living 
 
BASEC 
Business Administration System for Ethical Committees 
CI 
 
Confidence Interval 
CRF 
 
Case report form 
eCRF  
Electronic Case Report Form 
HRA  
Human Research Act 
HRO   
Ordinance on Human Research Ordinance 
ICC 
 
Intraclass Correlation Coefficient 
PI 
 
Principal Investigator 
PROM  
Patient Reported Outcome Measure 
REDCap  
Research Electronic Data Capture System 
RTS 
 
Return to Sports 
SIR 
 
Shoulder Instability Registry 
SIRSI  
Shoulder Instability Return to Sport Index 
SIRSI-D  
Shoulder Instability Return to Sport Index - Deutsch 
sSSV  
Sport Subjective Shoulder Value  
SSV 
 
Subjective Shoulder Value  
WOSI  
Western Ontario Shoulder Instability Index 
 
 

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1 STUDY SYNOPSIS 

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Sponsor / 
Sponsor-
Investigator 
Dr. Asimina Lazaridou, PhD 
Head of Research Group Upper Extremities and Hand 
Teaching, Research & Development  
Lengghalde 2 
8008 Zürich 
+41 44 385 79 77 
Asimina.lazaridou@kws.ch 
 
Study Title 
Translation and validation of the Shoulder Instability Return to Sports Index (SIRSI) and 
Tampa Scale of Kinesiophobia Shoulder Instability (TSK-SI) into German 
 
Short Title / 
Study ID 
OE-236 SIRSI TSK-SI Validation 
Protocol Version 
and Date 
Version 2 (dated 09/07/2024) 
Study 
Registration 
Clinicaltrials.gov  
SNCTP 
Study Category 
and Rationale 
Risk Category A 
Background and 
Rationale  
Return to Sports (RTS) is an important outcome measure after shoulder instability treatment. 
The concept of Return to Sport is multifactorial consisting of physical, psychological, and 
social/contextual factors in an interplay with sociodemographic and injury factors. The 
Shoulder Instability Return to Sport Index (SIRSI) measures psychological readiness to 
return to sports in the shoulder instability.  Similarly the Tampa Scale for Kinesiophobia 
(TSK) has been invented to measure an excessive fear of movement due to painful injury in 
chronic low back pain. The Scale was then adapted to the shoulder instability cohort. 
However, both questionnaires are currently not available in German and therefore not 
scientifically available for a German speaking population,  
Risk / Benefit 
Assessment 
Risk / benefit assessment 
Objective(s) 
The aim of the project is to translate the Shoulder Instability Return to Sports Index (SIRSI) 
and Tampa Scale of Kinesiophobia Shoulder Instability (TSK-SI) into a German version and 
assess its validity in a Swiss-German population of patients with shoulder instability treated 
conservatively or surgically and planning to return to sports. 
Endpoint(s) 
Shoulder Instability Return to Sports Index (SIRSI) 
Tampa Scale of Kinesiophobia – Shoulder Instability (TSK-SI) 
Western Ontario Shoulder Instability Index (WOSI) 
Subjective Shoulder Value (SSV) 
Sport Subjective Shoulder Value (sSSV) 
Return to Sports Level  
Study Design 
single centre cross sectional confirmatory analysis to validate a patient reported outcome 
measure.  
Statistical 
Considerations 
Internal consistency, which measures the extent to which items within the questionnaire are 
correlated with one another, will be assessed using Cronbach's alpha coefficient.  
Test-retest reliability will be examined by administering the questionnaire to participants on 
two different timepoints one week apart and calculating the correlation between their scores.  
Content validity will be established by ensuring that the items in the questionnaire adequately 
cover all relevant aspects of the constructs.  
Construct validity will be evaluated through factor analysis to confirm the underlying factor 
structure of the questionnaire and assess its convergent and divergent validity with other 
related measures.  
Criterion validity will be examined through concurrent validity by comparing the scores of the 
SIRSI questionnaire with SSV and WOSI.  
All statistical analyses are conducted in R. 
Inclusion- / 
Exclusion 
Criteria 
Inclusion Criteria 
Had an instability event* within last year 
Provided general consent for local shoulder instability register 
Under the age of 18 years  
 
Exclusion Criteria 
Are at least three months after surgery or instability event  
Must endeavor to return to their sport 

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Have another physical or psychological disorder not related to shoulder instability 
compromising return to sports 
Have a language barrier to complete the questionnaires in German  
Are legally incapable of participating in research studies 
Number of 
Participants with 
Rationale 
The Sample Size was calculated to N=135. This leads to a satisfying precision for the 
aforementioned estimates and includes a 15% dropout rate.  
Study 
Intervention 
Usage of the Shoulder Instability Return to Sports Index (SIRSI) and Tampa Scale of 
Kinesiophobia Shoulder Instability (TSK-SI) 
Control 
Intervention 
Not applicable 
Study 
procedures 
Upon identification in the local instability register at the Schulthess Klinik Zürich, patients 
receive an email with a link to the eCRF containing the German version of the SIRSI the 
TSK-SI, the WOSI, the SSV and sSSV, information on the RTS status and demographic and 
clinical information. Entering the link from the eCRF in the email is considered consent to the 
study which is explicitly explained. Upon completion of the first round eCRF a second round 
eCRF is sent automatically after seven days containing the German version of the SIRSI. 
The Data is stored within the REDCap database.  
Study Duration 
and Schedule 
Planned 01/07/2024 of First-Participant-In 
Planned 31/07/2025 of Last-Participant-Out 
Investigator(s) 
Dr. Asimina Lazaridou, PhD 
Head of Research Group Upper Extremities and Hand 
Teaching, Research & Development  
Lengghalde 2 
8008 Zürich 
+41 44 385 79 77 
Asimina.lazaridou@kws.ch 
 
Jan Schätz, M.Sc. PT 
Research Assistant 
Teaching, Research & Development  
Lengghalde 2 
8008 Zürich 
+41 44 385 7583 
Jan.schaetz@kws.ch 
Study Center(s) 
Schulthess Klinik Zürich, Lengghalde 2, 8008 Zürich, Switzerland 
Data privacy 
Project data will be handled with uttermost discretion and is only accessible to authorized 
GCP trained personnel who require the data to fulfil their duties within the scope of the 
research project. On the CRFs and other project specific documents, participants are only 
identified by a unique participant number. A participant identification list will be managed and 
stored by a designated project staff at Schulthess Klinik. The project leader affirms and 
upholds the principle of the patients’ right to privacy and that they shall comply with 
applicable privacy laws. Exported files will not contain any patient personal data and are 
pseudo-anonymized. The IT Department of the Schulthess Klinik will perform systematic data 
backup to prevent data loss or misuse.  
All materials pertaining to the study, including patient questionnaires, will be documented into 
a Trial Master File by the study coordinator, sorted and kept in closed archives at the 
teaching, research and development department at Schulthess Klinik. All study data must be 
archived for a minimum of 10 years after termination or premature termination of the project. 
Ethical 
consideration 
There is currently no tool available for the German speaking population, hence this part of 
treatment is left to subjective interpretation or related measures like strength, range of motion 
or anamnesis. Once the SIRSI is culturally adapted to the German population meaning 
Switzerland, Germany and Austria, it will help clinicians and researcher to objectively estimate 
the ability to RTS. For patients this means a safer RTS and potentially reduces the risk of re-
injury. No vulnerable patients are planned to be enrolled in this study.  
GCP Statement 
This study will be conducted in compliance with the protocol, the current version of the 
Declaration of Helsinki, the ICH-GCP, the HRA as well as other locally relevant legal and 

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2 BACKGROUND AND PROJECT RATIONALE  
Return to Sports (RTS) is an important outcome measure after shoulder instability 
treatment (Abdul-Rassoul et al., 2019). While the definition of returning to sport is not 
clear (Doege et al., 2021), efforts have been made to provide consensus (Ardern et al., 
2016). The concept of Return to Sport is multifactorial consisting of physical, psychological, 
and social/contextual factors in an interplay with sociodemographic and injury factors. 
Furthermore, different stages of RTS have been defined (Ardern et al., 2016). To take all 
factors into account, outcome measures like the ACL-RSI for anterior cruciate ligament 
ruptures have been invented (Webster et al., 2008). To provide such a measure for the 
shoulder instability cohort have adapted the ACL-RSI to a shoulder instability population 
and named it the Shoulder Instability Return to Sport Index (SIRSI)(Gerometta et al., 2018). 
Since then, this outcome has been frequently used to determine psychological readiness to 
RTS (Rossi et al., 2022). Despite an available German translation, published by a German 
insurance company (Return-to-Competition Schulter: Shoulder Instability-Return to Sport after 
Injury (SIRSI)-Skala (vbg.de), accessed 23.01.2024), the SIRSI is not scientifically available for 
a German speaking population, because this version has never been officially translated 
and validated. Similarly the Tampa Scale for Kinesiophobia (TSK) has been invented to 
measure an excessive fear of movement due to painful injury in chronic low back 
pain(Miller et al., 1991). The Scale was then adapted to the shoulder instability cohort(van 
Iersel et al., 2023). However, it is currently not available in German. Therefore, this project 
seeks to translate the SIRSI and TSK-SI into a German version and validate them in a 
German speaking population in Switzerland.  
3 PROJECT OBJECTIVES AND DESIGN  
3.1 Primary objective  
The aim of the project is to translate the Shoulder Instability Return to Sports Index (SIRSI) 
and Tampa Scale for Kinesiophobia – Shoulder Instability (TSK-SI) into a German version 
and assess its validity in a Swiss-German population of patients with shoulder instability 
treated conservatively or surgically and planning to return to sports.  
3.2 Primary endpoints 
The primary outcomes of interest are the SIRSI and the TSK-SI. The SIRSI has been adapted 
to the shoulder instability cohort from the Anterior Cruciate Ligament Return to Sport 
Index (ACL-RSI) by (Gerometta et al., 2018). It is composed of twelve items that are rated 
on a zero to ten. The single total score is calculated by multiplying the sum of each item and 
dividing it by 120. The worst score then is zero indicating no psychological readiness to 
RTS and 100 the best, indicating full psychological readiness to RTS. The TSK-SI is 
composed of 18 questions scored on a 4 point Likert-Scale from "Strongly agree" to 
"Strongly disagree". The lowest score is 18, indicating no kinesiophobia and 72, indicating 
regulatory requirements. A clinical trial covered by ClinO Chapter 4 may be conducted in 
accordance with other rules than ICH-GCP guidelines, provided that such rules are recognised 
in the specialty in question and the protection of participants and data quality and security are 
guaranteed (ClinO Art. 5, Abs 2). If the clinical trial is not conducted according to ICH-GCP 
guidelines, the paragraph above must be adapted accordingly. 

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highest level of kinesiophobia. The outcomes will be assessed electronically between three 
months and two years after surgery or instability event. 
3.3 Secondary endpoints 
As a secondary outcome the Western Ontario Shoulderinstability Index (WOSI) was 
developed by Kirkley (2003) and is the most prominent PROM in clinic and research for 
shoulder instability. The WOSI consists of 21 items and four domains: Physical symptoms 
(10 items), Sports, recreation, and work (4 items), lifestyle (4 items) and emotions (3 
items). The scale for each item ranges from 0 to 100, allowing for a total score of 0 (best) to 
2100 (worst). A transformed value ranging from 0 to 100 may be calculated by dividing the 
total score by 21 and subtracting it from 100. This allows for the common scale of 0 (worst) 
to 100 (best).  
The subjective shoulder value (SSV) was introduced by Gilbart and Gerber (2007) and 
provides a simple measure to represent shoulder functionality during activities of daily 
living (ADL). The patients are asked " “What is the overall percent value of your shoulder if 
a completely normal shoulder represents 100%?" if difficulties emerge with estimating a 
percentage another possibility is to ask "A completely normal shoulder would cost you 
€1000. How much would you be willing to pay for yours?" (Gilbart & Gerber, 2007). 
Because the standard SSV might lack sport specific context Descamps et al (2023) 
suggested the sport subjective shoulder value (sSSV) with the question "Regarding sports 
practice, what is the overall percent value of your shoulder, if a completely normal 
shoulder represents 100% and a non-functional shoulder represents 0%?". Both scales 
result in a value between zero and 100, where zero means no subjective functionality 
during ADL or Sport respectively (Descamps et al., 2023). 
Ardern et al (2016) defined RTS as that the athlete has returned to his previous sport but 
not necessarily at the same performance level and differentiated it to return to 
participation and return to performance. This spectrum will be assessed using custom build 
questions to determine the RTS level (Ardern et al., 2016).  
3.4 Study Design 
This study is a single centre cross sectional confirmatory analysis to validate two patient 
reported outcome measures.  
4 PROJECT POPULATION AND STUDY 
PROCEDURES 
4.1 Project population 
The targeted population to sample from comprises patients with conservative or operative 
treatment of anterior shoulder instability, who wish to return to sports after a shoulder 
instability event.  
An instability event is defined as a complete dislocation of the glenohumeral joint that 
needs to be repositioned by a health care professional or repositioned itself spontaneously, 
or a subluxation where the shoulder almost dislocates however not completely. Not an 
instability event are voluntarily dislocations or subluxations that can be provoked by the 
patient.  

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4.2 Inclusion criteria 
Patients are included if they had a shoulder instability event within last year, where an 
instability event is defined as a) a complete dislocation of the glenohumeral joint that had 
to be reduced by a clinician or reduced itself spontaneously or b) a subluxation that 
suddenly almost dislocated but not completely. Dislocations or subluxations that can be 
induced by patients voluntarily are not considered an instability event. Patients must be 
above the age of 18 years. Furthermore, they must have signed a general consent for the 
use of data in scope of the local shoulder instability register at the Schulthess Klinik Zürich.  
4.3 Exclusion criteria  
Patients are excluded if they are not at least three months after the last instability event or 
a surgery for shoulder instability, if they do not endeavor to return to their sport, have 
another physical or psychological disorder not related to shoulder instability that 
compromises return to sport, have a language barrier to complete the questionnaires in 
German or are legally incapable of participating in this study.  
 
Table 1: Overview over the inclusion and exclusion Criteria 
Inclusion Criteria 
Exclusion Criteria 
1. Had an instability event within last year 
2. Provided general consent for local shoulder 
instability register 
3. Adult patients aged 18 or older 
1. 
Are at least three months after surgery or 
instability event  
2. 
Must endeavor to return to their sport 
3. 
Have another physical or psychological 
disorder not related to shoulder instability 
compromising return to sports 
4. 
Have a language barrier to complete the 
questionnaires in German  
5. 
Are legally incapable of participating in 
research studies 
4.4 Sample Size  
According to the estimates that Gerometta et al (2018) provided in their validation study 
on the development of the SIRSI, the sample size to detect a Cronbach's alpha of 0.96 with a 
95%-CI width of 0.1 is 9 patients. To detect a Pearson correlation coefficient of 0.71 with a 
CI-width of 0.2 a sample size of 99 is warranted and to detect a difference in means of 22.8 
with a CI-width of 20 a sample size of 117 is necessary. To account for a dropout rate of 
15% in this cohort a final sample size of 135 is needed to perform the below-mentioned 
analysis with a satisfying precision. As the TSK-SI is relatively new, no data is available to 
estimate the mean and standard deviations of the TSK-SI. Therefore, to validate the TSK-SI 
the sample size calculated for the SIRSI is considered sufficient. Sample size calculations 
have been conducted with the help of the presize package (Haynes et al., 2021) and the 
congruent web based application (https://shiny.ctu.unibe.ch/presize/, accessed on 
03.04.2023).  
 
     sample size for Cronbach's alpha  
  calpha  k n conf.width conf.level     lwr       upr 

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1   0.96 12 9        0.1       0.95 0.88588 0.9892657 
 
     sample size for pearson 's correlation coefficient  
     r  n conf.width conf.level       lwr       upr 
1 0.71 99        0.2       0.95 0.5961453 0.7958619 
 
 
     sample size for mean difference with equal variance  
  delta  sd1  sd2       n1      n2 conf.width conf.level  lwr  upr 
1  22.8 26.6 26.6 71.82715 45.2511         20       0.95 12.8 32.8 
   
4.5 Recruitment, screening and informed consent procedure 
The recruiting takes place at the Schulthess Klinik Zürich. Patients who provided consent 
for the further use of health-related personal data for research purposes and were included 
in the local shoulder instability registry (SIR) (BASEC: 2020-01091), are screened for the 
inclusion criteria 1, 2 and 3.  
Those patients will be contacted by email. In the email the study purpose, inclusion- and 
exclusion criteria are explained and a link to the eCRF is provided, as well as a study 
information attached. Furthermore, it is explained, that filling out the eCRF is considered as 
an agreement to participate in this study similar to a written consent. This procedure is 
valid according to the human research ordinance (HRO) Chapter 2 Article 9, when a study 
of risk category A with an adult capable of judgement and a disproportionate effort of 
providing a written informed consent is present. The ethics committee then has to be 
informed of this procedure and the burden of re-sending the written informed consent can 
so be reduced The Email can be found in Appendix 1. Patients will not receive any 
compensation for participating.  
4.6 
Study procedures 
Upon return of written consent, patients receive an email with a link to the eCRF. This is 
composed in REDCap and contains a final check on the inclusion and exclusion criteria, the 
German version of the SIRSI, the German Version of the TSK-SI, the German Version of the 
WOSI, the SSV and sSSV, information on the RTS status and demographic and clinical 
information. If not completed reminders are sent every week for four times. Upon completion of 
the first round eCRF (T1) a second round eCRF (T2) is sent automatically after seven days 
containing another check on exclusion criteria and the German version of the SIRSI. If not 
completed three reminders are sent daily therefore a maximum time of ten days between 
measures (T1 and T2) is not exceeded. The duration to fill out the first round of questionnaires 
should take around 15 minutes and the second round around five minutes. The Data is stored 
within the REDCap database.  
4.7 Withdrawal and discontinuation 
The participation in the study is voluntary and all patients have the right to withdraw 
consent for participation in the study without prejudice. All data collected up to the time of 

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withdrawal will be used in the analysis as appropriate. Should a patient withdraw consent, 
he or she will be further treated and followed-up according to routine practice in the 
Schulthess Klinik Zürich. No further project-specific examinations or questionnaires will be 
performed. Patients are withdrawn from the study, if between T1 and T2 another 
instability event or other physical or psychological pathology that interferes with the RTS 
progress occurs. This information is asked for in the beginning of the second round in the 
eCRF. Lost to follow-up is defined as the subject does not complete questionnaires or 
follow-up visits but has not “officially” withdrawn from the project. To consider a subject 
lost to follow-up, the PI should make all reasonable efforts to locate and establish 
communication with the subject. All attempts should be documented within the source 
documents, indicating date, time, method, and site personnel. Withdrawal has no positive 
or negative consequences for the patient. In such cases, the clinical data already collected 
can continue to be used for regulatory and scientific evaluations. 
5 STATISTICS AND METHODOLOGY 
5.1 Translation plan 
The translation of the SIRSI and TSK-SI into a German follows the guideline of Beaton et al 
(2000) however little adjustments were made. The original SIRSI was translated into five 
German versions. Two by two researchers, one with background in occupational therapy 
and psychology (D.B.) and one with a background in physiotherapy (J.S.). One by a patient 
with a history of shoulder dislocations, conservative therapy, surgery and return to sports. 
One online translation by deepl.com (https://www.deepl.com/translator, accessed on 
20.02.2024) and the available German version by the German insurance company ((Return-
to-Competition Schulter: Shoulder Instability-Return to Sport after Injury (SIRSI)-Skala (vbg.de), 
accessed 23.01.2024). The TSK-SI was translated into four German versions. Two by two 
researchers, one with background in sport science and data management (T.S.) and one 
with a background in physiotherapy (J.S.). One by the same patient described above and 
one again by deepl.com (https://www.deepl.com/translator, accessed on 29.05.2024) 
From these versions a consensus version for the SIRSI was developed by D.B. and J.S. and 
the TSK-SI by T.S. and J.S.. Then a backtranslation was done by an English native speaker. 
The resulting English version was compared to the original SIRSI and TSK-SI and the 
German version was adapted by the respective researchers. Another backtranslation was 
then done to check for successful adaptations. No further adjustments were made. The 
German version of the SIRSI was then named SIRSI-D and TSK-SI was named TSK-SI-D. 
The SIRSI-D and TSK-SI-Dwas pilot tested on 20 patients each, who attend to outpatient 
physiotherapy at the Schulthess Klinik. The SIRSI-D will be handed out on paper alongside 
with a brief feedback sheet. The sheets are returned to the PI and if decided useful by the 
researchers, the suggestions of the patients are incorporated into the final SIRSI-D or TSK-
SI-D version that are used for the further validation process.  
5.2 Statistical analysis plan 
 
The reliability and validity of the German version of the Shoulder Instability-Return to 
Sport after Injury (SIRSI-D) and Tampa Scale of Kinesiophobia-Shoulder Instability (TSK-
SI-D) score will be assessed through rigorous psychometric evaluation procedures. 

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Reliability will be evaluated to ensure the consistency and stability of the questionnaire 
over time. 
Internal consistency, which measures the extent to which items within the questionnaire 
are correlated with one another, will be assessed using Cronbach's alpha coefficient.  
Test-retest reliability will be examined by administering the questionnaire to participants 
on two different timepoints one week apart and calculating the correlation between their 
scores.  
Validity will be assessed to determine the extent to which the questionnaire measures the 
intended constructs of shoulder instability and return to sport after injury.  
Content validity will be established by ensuring that the items in the questionnaire 
adequately cover all relevant aspects of the constructs.  
Construct validity will be evaluated through factor analysis to confirm the underlying 
factor structure of the questionnaire and assess its convergent and divergent validity with 
other related measures.  
Criterion validity will be examined through concurrent validity by comparing the scores of 
the SIRSI-D and TSK-SI-D questionnaire with SSV and  WOSI.  
Overall, these psychometric evaluation procedures will ensure that the German version of 
the SIRSI and TSK-SI-D scores are both reliable and valid for assessing shoulder instability 
and return to sport after injury in a German-speaking population. All statistical analyses 
are conducted in R (R Core Team (2022)).  
5.3 Handling of missing data  
Missing Data is reduced by the "soft required function" in REDCap, where patients are 
reminded if a question is not filled in but proceeding is possible. The exception are the 
checks of the inclusion criteria which are mandatory to proceed. This ensures that patients 
do not drop out completely. In addition, patients will be contacted via mail via a researcher, 
if an item is missing. In the analysis missing items in the WOSI, TSK-SI-D and SIRSI-D will 
be imputed by the means, if missing at random and a sensitivity analysis is performed to 
ensure robustness. Other missing items, not in the WOSI TSK-SI-D or SIRSI-D, will be 
treated as such. If more than 15% of the sample have incomplete questionnaires even after 
email contact, the sampling is extended.  
5.4 Statistical quality considerations 
The statistical analysis plan will be preregistered at clinicaltrials.gov  
(https://clinicaltrials.gov/, accessed at 10.04.2024).  
6 REGULATORY ASPECTS AND SAFETY 
6.1 Local regulations / Declaration of Helsinki 
This research project will be conducted in accordance with the protocol, the Declaration of 
Helsinki (World-Medical-Association, 2018) ,the principles of Good Clinical Practice, the 
Human Research Act (HRA) (Eidgenossenschaft, 2011) and the Human Research Ordinance 
(HRO) (Bundesrat, 2013) as well as other locally relevant regulations. The project leader 
acknowledges his responsibilities as both the project leader and the Sponsor. 
6.2 (Serious) Adverse Events and notification of safety and 

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protective measures 
An Adverse Event (AE) is any untoward medical occurrence in a patient or a clinical 
investigation subject which does not necessarily have a causal relationship with the trial 
procedure. An AE can therefore be any unfavourable or unintended finding, symptom, or 
disease temporally associated with a trial procedure, whether or not related to it. 
 
A Serious Adverse Event (SAE) (ClinO, Art. 63) is any untoward medical occurrence that 
Results in death or is life-threatening, 
Requires in-patient hospitalisation or prolongation of existing hospitalisation, 
Results in persistent or significant disability or incapacity, or 
Causes a congenital anomaly or birth defect  
 
Both Investigator and Sponsor-Investigator make a causality assessment of the event to the 
trial intervention (see table below based on the terms given in ICH E2A guidelines). Any 
event assessed as possibly, probably or definitely related is classified as related to the trial 
intervention. 
 
Relationship 
Description 
Definitely 
Temporal relationship 
Improvement after dechallenge* 
Recurrence after rechallenge 
(or other proof of drug cause) 
Probably 
Temporal relationship 
Improvement after dechallenge 
No other cause evident 
Possibly 
Temporal relationship 
Other cause possible 
Unlikely 
Any assessable reaction that does not fulfil the above conditions 
Not related 
Causal relationship can be ruled out 
*Improvement after dechallenge only taken into consideration, if applicable to reaction 
 
Both Investigator and Sponsor-Investigator make a severity assessment of the event as 
mild, moderate or severe. Mild means the complication is tolerable, moderate means it 
interferes with daily activities and severe means it renders daily activities impossible. 
 
6.2.1 Reporting of SAEs (see ClinO, Art. 63) 
All SAEs are documented and reported immediately (within a maximum of 24 hours) to the 
Sponsor-Investigator of the study. 
If it cannot be excluded that the SAE occurring in Switzerland is attributable to the 
intervention under investigation, the Investigator reports it to the Ethics Committee via 
BASEC within 15 days. 
Recurrent instability events (as defined above) are a common occurrence in treatment of 
shoulder surgery and are not considered as due to the intervention of this study (i.e. usage 
of a questionnaire).  
 

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6.2.2 Follow up of (Serious) Adverse Events 
Any (S)AEs that occur and prolong over the termination of the study will be followed up via 
the treating surgeon according to the routine of the clinic. The research team will be in 
contact with this respective surgeon and evaluate, if the (S)AE interferes with the 
interpretability of the data 
 
6.2.3 Notification of safety and protective measures (see ClinO, Art 62, b) 
If immediate safety and protective measures have to be taken during the conduct of the 
study, the investigator notifies the Ethics committee of these measures, and of the 
circumstances necessitating them, within 7 days. 
6.3 (Periodic) safety reporting 
An annual safety report (ASR) is submitted once a year to the local Ethics Committee by the 
Investigator (ClinO, Art. 43 Abs 1). 
6.4 Radiation 
No radiation expose due to this study is expected.  
6.5 Amendments 
Substantial changes to the study setup and study organization, the protocol and relevant 
study documents are submitted to the Ethics Committee for approval before 
implementation. Under emergency circumstances, deviations from the protocol to protect 
the rights, safety and well-being of human subjects may proceed without prior approval of 
the Ethics Committee. Such deviations shall be documented and reported to the Ethics 
Committee as soon as possible. 
Substantial amendments are changes that affect the safety, health, rights and obligations of 
participants, changes in the protocol that affect study objective(s) or central research topic, 
changes of study site(s) or of study leader and sponsor (ClinO, Art. 29). 
A list of all non-substantial amendments will be submitted once a year to the competent EC 
together with the ASR. 
6.6 Notification and reporting upon completion, discontinuation or 
interruption of the study 
If, during the research project, circumstances arise which could jeopardise the safety or 
health of the participants or lead to a disproportionate relationship between the risks and 
burdens and the benefits, all the measures required to ensure protection are to be taken 
without delay. The project leader is promptly notified (within 24 hours) if immediate 
safety and protective measures have to be taken during the conduct of the research project. 
The Ethics Committee will be notified via BASEC of these measures and of the 
circumstances necessitating them within 7 days. 
The Sponsor-Investigator and any other competent authority may terminate the study 
prematurely according in case of ethical concerns, insufficient recruitment or when the 
safety of the participants is doubtful or at risk. Upon premature study termination or study 
interruption, the Ethics Committee is notified via BASEC within 15 days.  

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Upon project completion or discontinuation, the Ethics Committee is notified within 90 
days. The TMF including the written signed consents are stored in the archives of the 
Schulthess Klinik Zürich, the project database is stored electronically within the REDCap 
database. The data will remain coded. The patient identification will be known only at the 
respective project site by authorized personnel who are bound to confidentiality by 
contract. 
A final report is submitted to the Ethics Committee via BASEC within a year after 
completion or discontinuation of the study. 
6.7 Insurance 
Because this is Category A1 with minimal risk, there is no insurance requirement (Art. 12 
HRO and insurance is through the clinic's liability). 
7 FURTHER ASPECTS 
7.1 Overall ethical considerations 
The participation of patients is voluntary. Withdrawal is possible without justification at 
any time without prejudice for further routine treatment and follow-up. This project and 
related data analyses are conducted in compliance with the protocol, the current version of 
the Declaration of Helsinki, the ICH-GCP or ISO EN 14155 (as far as applicable) as well as 
all national legal and regulatory requirements of the HFG and HFV. Patients have the right 
to know any information derived from participating to this project. In this project, we do 
not foresee any incidental findings that should not be communicated to the concerned 
patients. Upon agreement by a patient, medical information can be provided to the family 
doctor, or other treating physicians to ensure his/her well-being. This project complies 
with the regulatory requirements of the HRA and HRO. The prerequisite for carrying out 
the research project is the approval of the Cantonal Ethics Committee. 
7.2 Risk-Benefit Assessment  
Patients provide time effort of approximately 15 minutes and five minutes to complete two 
rounds of online questionnaires. Health-related risk is negligible. The Patient 
questionnaires may be perceived long by participants and address issues that could be 
embarrassing to respond to (e.g. anxiety, unpreparedness, inadequateness).  
It is considered that these project-specific procedures provide only minimal risk and 
discomfort to the patients. There is no clinical risk identified for the participants associated 
with the data collection described in the protocol. 
Confidentiality risk associated with non-anonymized individual data being published is 
kept to minimum by strict confidentiality rules. No personal individual data will be 
captured into the project database, except the patients’ email address  that will be 
exclusively used to send project questionnaire for electronic data capture. Email addresses 
will not be exported from the REDCap database and therefore remain protected from 
unauthorized access. 
This study provides a questionnaire to measure psychological readiness to return to sport 
after shoulder instability and an analysis of its validity and reliability. There is currently no 
tool available for the German speaking population, hence this part of treatment is left to 
subjective interpretation or related measures like strength, range of motion or anamnesis. 

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Once the SIRSI is culturally adapted to the German population meaning Switzerland, 
Germany and Austria, it will help clinicians and researcher to objectively estimate the 
ability to RTS. For patients this means a safer RTS and potentially reduces the risk of re-
injury. 
The subjects will not benefit directly/explicitly from the participation in this study. 
7.3 Rationale for the inclusion of vulnerable participants  
Not applicable. No vulnerable patients will be enrolled in this study. 
8 QUALITY CONTROL AND DATA PROTECTION 
8.1 Quality measures  
The project team will ensure the completeness and consistency of the collected data.  For 
more details, see section 7.2. For quality assurance the Ethics Committee may visit the 
research sites. Direct access to the source data and all project related files and documents 
must be granted on such occasions. All investigators are trained according to the good 
clinical practice. All patient informed consents will be verified and confirmed. The study 
TMF will be monitored to ensure completeness of study documentation according to GCP 
guidelines.  
8.2 Data recording and source data 
Source data used encompasses the email address which is stored within the clinic 
information system. All other information can be retrieved from the local instability 
register, where patients provided signed written consent for (BASEC: 2020-01091). The 
postal address to sent the informed consent for this study to, is asked for in the invitation 
email (see Appendix 1). The eCRF encompasses the source and collected data as described 
in table 2.  
8.3 Electronic Data Capture system 
Study data will be entered and stored in the REDCap web-based electronic data capture 
system (Harris et al., 2009; REDCap web-based Electronic Data Capture system, 2017) that is 
hosted on a dedicated server within the protected IT environment of the Schulthess Klinik. 
This is a cost-effective and user-friendly system that is used worldwide for clinical 
research. REDCap is designed to limit data entry errors using pop-up menus, pre-specified 
values where applicable, consistency checks, automatic entry checking for implausible 
values and non-allowance for closing relevant data fields without entry specifications. 
REDCap conforms with Good Clinical Practice guidelines providing required features for 
data protection and integrity e.g. using password-protected access and change tracking.  
 
8.4 Data recording 
For this study, questionnaires in the German language were developed to capture all 
variables described in this protocol and are filled out by the participant him- or herself. 
Patients will complete their questionnaire electronically after invitation by email.  

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8.5 Confidentiality and coding 
Project data will be handled with uttermost discretion and is only accessible to authorized 
personnel who require the data to fulfil their duties within the scope of the research 
project. On the CRFs and other project specific documents, participants are only identified 
by a unique participant number. A participant identification list will be managed and 
stored by a designated project staff at Schulthess Klinik. It will be kept in a place (an 
electronic folder or paper-based form) only accessible to authorized staff. The project 
leader affirms and upholds the principle of the patients’ right to privacy and that they shall 
comply with applicable privacy laws. Especially, anonymity of the patients shall be 
guaranteed when presenting the data at scientific meetings or publishing them in scientific 
journals. Study data will be exported from the REDCap system into statistical software for 
statistical analyses. Exported files will not contain any patient personal data and be 
accessible only to authorized staff. Data transformations and analyses will be primarily 
implemented using statistical software and fully documented within programming files. 
Variables required for the analyses are transformed or created after data transfer into 
Stata and saved in the final analysis dataset. This final dataset contains only pseudo-
anonymous data. The IT Department of the Schulthess Klinik will perform systematic data 
backup to prevent data loss or misuse. This project does not collect any biological material.  
8.6 Retention and destruction of project data  
All materials pertaining to the study, including patient questionnaires, will be documented 
into a Trial Master File by the study coordinator, sorted and kept in closed archives at the 
teaching, research and development department at Schulthess Klinik.  
All study data must be archived for a minimum of 10 years after termination or premature 
termination of the project. 
9 FUNDING / PUBLICATION / DECLARATION OF 
INTEREST 
Study costs are paid by the upper extremities research division of the teaching, 
development and research department at the Schulthess Klinik. No further funding is 
available.  
9.1 Publication policy 
The results of this project will be published in peer-reviewed medical journals, 
independent of the results. Data analyses will be performed upon clear formulation of 
clinical questions according to this study protocol.  
The authorship is regulated according to the content of the publication and the guidelines 
of the Swiss Academies of Arts and Sciences. 
 
9.2 Conflict of interest 
No conflict of interest in terms of independence, intellectuality, finance and proprietary 
exist in this project.  
 

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10 APPENDIX 
10.1 Appendix 1: Invitation Email  
 
The Email contains German language, which is not accepted on clinicaltrials.gov therefore this part 
is deleted, and may be requested by the authors.