Author's response to reviews

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1 Author's response to reviews Title: Evaluation of an internet-based aftercare programme to improve vocational reintegration after inpatient medical rehabilitation: study protocol for a cluster-randomised controlled trial Authors: Ruediger Zwerenz (ruediger.zwerenz@unimedizin-mainz.de) Katharina Gerzymisch (katharina.gerzymisch@unimedizin-mainz.de) Jens Edinger (j.edinger@kreiskliniken-dadi.de) Martin Holme (Dr.Martin.Holme@drv-bund.de) Rudolf J Knickenberg (Rudolf.Knickenberg@psychosomatische-klinik-bad-neustadt.de) Sieglinde Spoerl-Doench (Sieglinde.Spoerl-Doench@frankenklinik-bad-neustadt.de) Ulrich Kiwus (Dr.Ulrich.Kiwus@drv-bund.de) Manfred E Beutel (manfred.beutel@unimedizin-mainz.de) Version: 2 Date: 21 December 2012 Author's response to reviews: see over

2 Department of Psychosomatic Medicine and Psychotherapy Prof. John Norrie Associate Editor / Reviewer Trials Director: Univ.- Prof. Dr. med. Dipl.-Psych. Manfred E. Beutel Dr. biol. hom. Dipl.- Psych. Rüdiger Zwerenz Geb. 601, 9.OG, Zi. 907 Telefon:+49 (0) Telefax: +49 (0) ruediger.zwerenz@unimedizin-mainz.de Mainz, Subj: Revision of MS , entitled "Evaluation of an internet-based aftercare programme to improve vocational reintegration after inpatient medical rehabilitation: study protocol for a cluster-randomised controlled trial" Dear Prof. Norrie, we appreciate the opportunity to resubmit our manuscript Evaluation of an internet-based aftercare programme to improve vocational reintegration after inpatient medical rehabilitation: study protocol for a cluster-randomised controlled trial (MS: ) for review and publication to Trials. We also like to thank you for your constructive comments in your reviewer s report and for granting extra time to make our revision. We thoroughly revised the manuscript, following your suggestions as seen in our comments below: Comments 1 & 2 Response: In principle, our trial determines the efficacy of an add-on to inpatient rehabilitation. By law, inpatient rehabilitation aims at restoring work capacity and promoting return to work, regardless of the specific medical field (e.g. psychosomatic, cardiological and orthopaedic). Thus, coping with workrelated stress is a mandatory part of rehabilitation. By introducing the treatment modules we attempted to standardize this part of medical rehabilitation as much as possible. When patients are admitted to medical rehabilitation, there is plenty of interaction between consecutive cohorts of patients. The purpose of the clustering is to avoid conflicts and contamination between patients getting resp. not getting the aftercare intervention, although they are in treatment at the same time in the same rehabilitation center. We have added comments in the text (page 8). The actual intervention in aftercare indeed rests upon an individually based access to the internet. UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz. Körperschaft des öffentlichen Rechts Vorstand: Univ.-Prof. Dr. med. Guido Adler (Vorsitzender und Medizinischer Vorstand), Norbert Finke (Kaufmännischer Vorstand), Evelyn Möhlenkamp (Pflegevorstand), Univ.-Prof. Dr. med. Dr. rer. nat. Reinhard Urban (Wissenschaftlicher Vorstand) Vorsitzende des Aufsichtsrates: Doris Ahnen Langenbeckstr Mainz. Telefon +49 (0) Bankverbindung: Sparkasse Mainz BLZ Konto-Nr. 75

3 Seite 2/4 As you have written, during inpatient rehabilitation the only difference between the two randomised arms prior to the actual intervention is the instruction of the patients during the second part of module 4. In order to recruit patients for online aftercare, it is crucial to gain access to them during inpatient rehabilitation. Our intention therefore is to give instructions for the specific intervention in each randomised arm in order to motivate patients to use the aftercare interventions with comparable frequency in both randomised arms. Because of the differing amount of aftercare interventions between the two randomised groups, we have to consider, that motivation to take part after inpatient rehabilitation could also differ between the two groups. We take this into account in our sample size calculation and in final data analysis we have to control for this (e.g. participation rate, indicator variables for motivation). We added comments on the impact of clustering on the sample size (page 12). Comment 3 Response: We replaced condition with randomised arm or randomised group in the whole manuscript. Comment 4 Response: We have deliberately chosen three of the major indications in the German medical rehabilitation system comprising of the main causes for work disability and premature pension. As we could establish in previous trials with inpatient interventions for psychosomatic, cardiovascular and orthopaedic rehabilitation patients, there are comparable rates of vocational problems in these three indications. In the previous work, we could also establish that the inpatient interventions are effective in improving work-related attitudes across these three categories. Still, we expect differences between the indications regarding age, gender, comorbidities, etc. We therefore plan to take category of patient into account as an outcome predictor. We added our comments on page 14. Comment 5 Response: The criterion of vocational strained was defined more carefully (see page 6). Clearly both interactions are possible, i.e. work related stress could be something that has developed before the medical event as well as it could be a consequence of the psychosomatic, orthopaedic or cardiovascular event. We mentioned this in the discussion (see page 13). Comment 6 Response: We described the control intervention more detailed, so that it is clearer how often participants are reminded and we also added the topics of the reminders (see page 9). Comment 7

4 Seite 3/4 Response: Private undisturbed internet access means that patients should have (1) a private internet access, so that they don t use internet access at work for our intervention and (2) should have an internet access they can use without being disturbed by others, so that they could take their time for the interventions in both groups. Explanation in the text was clarified (page 6). Comment 8 Response: A blinded assessment of the outcome was not possible, because patients needed to be informed about the group and intervention they are randomised to, during inpatient rehabilitation. However, our main outcome is assessed by study participants, independent from the online therapist. We discussed this on pages Comment 9 Response: We expect that the risk for adverse events will be very low. Nevertheless participants have the possibility to contact us at any time via or on a mobile help number with the guarantee for a response during daytime on weekdays (08:00 a.m p.m.). During weekends and at all other times patients could use a German wide crisis telephone number indicated on our internet platform. All adverse events are documented and supervised by the principal investigators, who will contact the participants who seem to be in crisis for further diagnostics via telephone resp. necessary referrals to practitioners nearby the study participant. We added these comments in the text (see page 13). Comment 10 Response: We excluded anyone aged over 59 because the likelihood of retirement is very high over 59 years, limiting therapeutic access to these patients (see page 6). Comment 11 Response: We carefully edited the chapter sample size calculation and adjusted to clustering (see pages 11-12). Therefore we had to revise the minimum number of cases needed for robust statistical analyses from 310 per condition to 475 for the whole sample. Comment 12 Response: Of course we would have preferred for all patients to have online access in the clinics in order to increase motivation for participation. However, internet access for patients to date has not been implemented in many German clinics, and we therefore had to adjust to the state of technological availability. As patients only have the option to fill out study questionnaires during inpatient treatment, but do not gain full access to our respective internet platforms we do not expect an effect on our main outcome. Patients fill out identical questionnaires at baseline, both online and as paper and pencil. However, we cannot completely preclude that filling out questionnaires online during

5 Seite 4/4 the inpatient rehabilitation may increase participation in our program. We will therefore compare the frequency of utilization between those who fill out baseline questionnaires online and offline. We carefully discussed the influence of paper and pencil vs. online assessment at baseline and the possible effects of a missing online-introduction on the participation rate for the aftercare intervention (see page 16). Comment 13 Response: We discussed our planned statistical analyses and defined our primary outcome more precisely. On page 13 we point to the analysis of a continuous score of our primary outcome and define the primary endpoint with the end of our aftercare intervention resp. 12 weeks after inpatient rehabilitation. Comment 14 Response: We corrected for the two-sided level of significance of alpha = Please don t hesitate to contact us with any further comments or suggestions you may have. I hope this makes our manuscript eligible for publication in Trials. With kind regards, Dr. biol. hom. Rüdiger Zwerenz Corresponding author