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. 2021 Oct 12;10(10):CD011589.
doi: 10.1002/14651858.CD011589.pub2.

Routine provision of feedback from patient-reported outcome measurements to healthcare providers and patients in clinical practice

Chris Gibbons  1 , Ian Porter  2 , Daniela C Gonçalves-Bradley  3   4 , Stanimir Stoilov  5 , Ignacio Ricci-Cabello  6 , Elena Tsangaris  7 , Jaheeda Gangannagaripalli  8 , Antoinette Davey  8 , Elizabeth J Gibbons  9 , Anna Kotzeva  10 , Jonathan Evans  8 , Philip J van der Wees  11 , Evangelos Kontopantelis  12 , Joanne Greenhalgh  13 , Peter Bower  14 , Jordi Alonso  15 , Jose M Valderas  16
Affiliations

Routine provision of feedback from patient-reported outcome measurements to healthcare providers and patients in clinical practice

Chris Gibbons et al. Cochrane Database Syst Rev. .

Abstract

Background: Patient-reported outcomes measures (PROMs) assess a patient's subjective appraisal of health outcomes from their own perspective. Despite hypothesised benefits that feedback on PROMs can support decision-making in clinical practice and improve outcomes, there is uncertainty surrounding the effectiveness of PROMs feedback.

Objectives: To assess the effects of PROMs feedback to patients, or healthcare workers, or both on patient-reported health outcomes and processes of care.

Search methods: We searched MEDLINE, Embase, CENTRAL, two other databases and two clinical trial registries on 5 October 2020. We searched grey literature and consulted experts in the field.

Selection criteria: Two review authors independently screened and selected studies for inclusion. We included randomised trials directly comparing the effects on outcomes and processes of care of PROMs feedback to healthcare professionals and patients, or both with the impact of not providing such information.

Data collection and analysis: Two groups of two authors independently extracted data from the included studies and evaluated study quality. We followed standard methodological procedures expected by Cochrane and EPOC. We used the GRADE approach to assess the certainty of the evidence. We conducted meta-analyses of the results where possible.

Main results: We identified 116 randomised trials which assessed the effectiveness of PROMs feedback in improving processes or outcomes of care, or both in a broad range of disciplines including psychiatry, primary care, and oncology. Studies were conducted across diverse ambulatory primary and secondary care settings in North America, Europe and Australasia. A total of 49,785 patients were included across all the studies. The certainty of the evidence varied between very low and moderate. Many of the studies included in the review were at risk of performance and detection bias. The evidence suggests moderate certainty that PROMs feedback probably improves quality of life (standardised mean difference (SMD) 0.15, 95% confidence interval (CI) 0.05 to 0.26; 11 studies; 2687 participants), and leads to an increase in patient-physician communication (SMD 0.36, 95% CI 0.21 to 0.52; 5 studies; 658 participants), diagnosis and notation (risk ratio (RR) 1.73, 95% CI 1.44 to 2.08; 21 studies; 7223 participants), and disease control (RR 1.25, 95% CI 1.10 to 1.41; 14 studies; 2806 participants). The intervention probably makes little or no difference for general health perceptions (SMD 0.04, 95% CI -0.17 to 0.24; 2 studies, 552 participants; low-certainty evidence), social functioning (SMD 0.02, 95% CI -0.06 to 0.09; 15 studies; 2632 participants; moderate-certainty evidence), and pain (SMD 0.00, 95% CI -0.09 to 0.08; 9 studies; 2386 participants; moderate-certainty evidence). We are uncertain about the effect of PROMs feedback on physical functioning (14 studies; 2788 participants) and mental functioning (34 studies; 7782 participants), as well as fatigue (4 studies; 741 participants), as the certainty of the evidence was very low. We did not find studies reporting on adverse effects defined as distress following or related to PROM completion.

Authors' conclusions: PROM feedback probably produces moderate improvements in communication between healthcare professionals and patients as well as in diagnosis and notation, and disease control, and small improvements to quality of life. Our confidence in the effects is limited by the risk of bias, heterogeneity and small number of trials conducted to assess outcomes of interest. It is unclear whether many of these improvements are clinically meaningful or sustainable in the long term. There is a need for more high-quality studies in this area, particularly studies which employ cluster designs and utilise techniques to maintain allocation concealment.

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Conflict of interest statement

All of the authors have completed deceleration of interest forms as standard procedure for undertaking a Cochrane review. These decelerations were updated and re‐checked prior to publication. With the exception of the following authors, all authors declared no known conflicts interest. The authors declaring below are not perceived to hold any conflict of interest related to the review and its work.

Chris Gibbons: Chris holds an National Institute for Health Research (UK) ‐ Post‐doctoral and career development Fellowship. This grant is designed to foster his development as an independent researcher. As part of this work, he will develop a computerised questionnaire administration system with the goal of improving patient‐provider communication in primary care.

Joanne Greenhalgh is currently President‐Elect of the International Society for Quality of Life Research (ISOQOL) and from 2021‐2023 will be president of ISOQOL.

Anna Kotzeva has not received any payment or services from a third party for any aspect of the submitted work. Ann would like to note the following, albeit that this does not constitute a conflict of interest with this review: In the beginning of the review Anna was employed by the Agencia de Qualitat i Avaluacio Sanitaries de Catalunya (Spain) and this institution has received grants from the Spanish Ministry of Science and Innovation and the European commission (ICT PSP as part of the Competitiveness and Innovation Framework Programme). Currently, Anna is employed by F. Hoffmann ‐ La Roche (Basel, Switzerland) but has not received any payment or funding for the work on this manuscript. The author has had financial relationships with: the Universitat Oberta de Catalonia (UOC) receiving remuneration for online lectures and development of educational materials; the European Patient Forum covering travel and accommodations expenses for speaking at conference workshops.

Jose Valderas has undertaken consultancy for the WHO but this is unrelated to this review.

Figures

1
1
Study flow diagram.
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
3
3
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
1.1
1.1. Analysis
Comparison 1: Quality of Life, Outcome 1: Quality of life (all generic)
2.1
2.1. Analysis
Comparison 2: General health perceptions, Outcome 1: General health perceptions (overall)
3.1
3.1. Analysis
Comparison 3: Functioning, Outcome 1: Physical functioning
3.2
3.2. Analysis
Comparison 3: Functioning, Outcome 2: Mental functioning
3.3
3.3. Analysis
Comparison 3: Functioning, Outcome 3: Social Functioning
4.1
4.1. Analysis
Comparison 4: Symptoms, Outcome 1: Pain
4.2
4.2. Analysis
Comparison 4: Symptoms, Outcome 2: Fatigue
4.3
4.3. Analysis
Comparison 4: Symptoms, Outcome 3: Dysponea
4.4
4.4. Analysis
Comparison 4: Symptoms, Outcome 4: Cough
4.5
4.5. Analysis
Comparison 4: Symptoms, Outcome 5: Nausea
4.6
4.6. Analysis
Comparison 4: Symptoms, Outcome 6: Depressive symptoms
4.7
4.7. Analysis
Comparison 4: Symptoms, Outcome 7: Anxiety symptoms
4.8
4.8. Analysis
Comparison 4: Symptoms, Outcome 8: Insomnia
4.9
4.9. Analysis
Comparison 4: Symptoms, Outcome 9: Anorexia
4.10
4.10. Analysis
Comparison 4: Symptoms, Outcome 10: Constipation
4.11
4.11. Analysis
Comparison 4: Symptoms, Outcome 11: Diarrhoea
5.1
5.1. Analysis
Comparison 5: Communication, Outcome 1: Patient‐physician communication
6.1
6.1. Analysis
Comparison 6: Clinician severity ratings, Outcome 1: Clinician severity ratings
7.1
7.1. Analysis
Comparison 7: Diagnosis, Outcome 1: Diagnosis and notations
8.1
8.1. Analysis
Comparison 8: Pharmacological treatment, Outcome 1: Pharmacological treatment
9.1
9.1. Analysis
Comparison 9: Counselling, Outcome 1: Counseling (provided or referred to)
10.1
10.1. Analysis
Comparison 10: Referral, Outcome 1: Referral
11.1
11.1. Analysis
Comparison 11: Visits, Outcome 1: Visits
11.2
11.2. Analysis
Comparison 11: Visits, Outcome 2: Emergency room visits
11.3
11.3. Analysis
Comparison 11: Visits, Outcome 3: Unscheduled visits
11.4
11.4. Analysis
Comparison 11: Visits, Outcome 4: Number of visits
11.5
11.5. Analysis
Comparison 11: Visits, Outcome 5: Length of visits
12.1
12.1. Analysis
Comparison 12: Sessions, Outcome 1: Number of sessions
13.1
13.1. Analysis
Comparison 13: Hospital admissions, Outcome 1: Hospital admissions (patients)
14.1
14.1. Analysis
Comparison 14: Length of stay, Outcome 1: Length of stay
15.1
15.1. Analysis
Comparison 15: Patient perceptions, Outcome 1: Self‐Efficacy
15.2
15.2. Analysis
Comparison 15: Patient perceptions, Outcome 2: Unmet needs
15.3
15.3. Analysis
Comparison 15: Patient perceptions, Outcome 3: Patient‐physician relationship
16.1
16.1. Analysis
Comparison 16: Patient satisfaction, Outcome 1: Patient satisfaction
17.1
17.1. Analysis
Comparison 17: Disease control, Outcome 1: Disease control
18.1
18.1. Analysis
Comparison 18: Quality of care, Outcome 1: Quality of care
19.1
19.1. Analysis
Comparison 19: Costs, Outcome 1: Overall costs
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    1. Nipp RD, El-Jawahri A, Ruddy M, Fuh C, Temel B, D'Arpino SM, et al. Pilot randomized trial of an electronic symptom monitoring intervention for hospitalized patients with cancer. Annals of Oncology 2019;30(2):274-80. - PMC - PubMed
Picardi 2016 {published data only}
    1. Picardi A, Lega I, Tarsitani L, Caredda M, Matteucci G, Zerella MP, et al. A randomised controlled trial of the effectiveness of a program for early detection and treatment of depression in primary care. Journal of Affective Disorders 2016;198:96-101. - PubMed
Pouwer 2001 {published data only}
    1. Pouwer F, Snoek FJ, Ploeg HM, Adèr HJ, Heine RJ. Monitoring of psychological well-being in outpatients with diabetes: effects on mood, HbA(1c), and the patient's evaluation of the quality of diabetes care: a randomized controlled trial. Diabetes Care 2001;24(11):1929-35. - PubMed
Priebe 2007 {published data only}
    1. Priebe S, McCabe R, Bullenkamp J, Hansson L, Lauber C, Martinez-Leal R, et al. Structured patient-clinician communication and 1-year outcome in community mental healthcare: cluster randomised controlled trial. British Journal of Psychiatry 2007;191:420-6. - PubMed
Probst 2013 {published data only}
    1. Probst T, Lambert MJ, Loew TH, Dahlbender RW, Göllner R, Tritt K. Feedback on patient progress and clinical support tools for therapists: improved outcome for patients at risk of treatment failure in psychosomatic in-patient therapy under the conditions of routine practice. Journal of Psychosomatic Research 2013;75(3):255-61. - PubMed
Puschner 2009 {published data only}
    1. Puschner B, Scho¨fer D, Knaup C, Becker T. Outcome management in in-patientpsychiatric care. Acta Psychiatrica Scandinavica 2009;120:308–19. - PubMed
Rand 1988 {published data only}
    1. Rand EH, Badger LW, Coggins DR. Toward a resolution of contradictions. Utility of feedback from the GHQ. General Hospital Psychiatry 1998;10(3):189-96. - PubMed
Reese 2009 {published data only}
    1. Reese RJ, Norsworthy LA, Rowlands SR. Does a continuous feedback system improve psychotherapy outcome? Psychotherapy 2009;46(4):418-31. - PubMed
Richardson 2008 {published data only}
    1. Richardson J, Chan D, Risdon K, Giles C, Cripps D. Does monitoring change in functioncommunity-dwelling older adults? A randomized controlled trial. Clinical Rehabilitation 2008;22:1061–70. - PubMed
Richardson 2019 {published data only}
    1. Richardson L, Zhou C, Gersh E, Spielvogle H, McCarty C. Check Yourself: a randomized trial of electronic screening and personalized feedback for adolescent health risk behaviors in primary care. Journal of Adolescent Health 2019;64(2):S41‐S42. - PMC - PubMed
    1. Richardson L, Zhou C, Gersh E, Spielvogle H, McCarty C. Effect of electronic screening with personalized feedback on adolescent health risk behaviors in a primary care setting: a randomized clinical trial. JAMA Network Open 2019;2(5):e193581. - PMC - PubMed
Rosenbloom 2007 {published data only}
    1. Rosenbloom SK, Victorson DE, Hahn EA, Peterman AH, Cella D. Assessment is not enough: a randomized controlled trial of the effects of HRQL assessment on quality of life and satisfaction in oncology clinical practice. Psycho-Oncology 2007;16(12):1069-79. - PubMed
Rubenstein 1995 {published data only}
    1. Rubenstein LV, McCoy JM, Cope DW, Barrett PA, Hirsch SH, Messer KS, et al. Improving patient quality of life with feedback to physicians about functional status. Journal of General Internal Medicine 1995;10(11):607-14. - PubMed
Ruland 2003 {published data only}
    1. Ruland CM, White T, Stevens M, Fanciullo G, Khilani SM. Effects of a computerized system to support shared decision making in symptom management of cancer patients: preliminary results. Journal of the American Medical Informatics Association 2003;10(6):573-9. - PMC - PubMed
Ruland 2010 {published data only}
    1. Ruland CM, Holte HH, Røislien J, Heaven C, Hamilton GA, Kristiansen J, et al. Effects of a computer-supported interactive tailored patient assessment tool on patient care, symptom distress, and patients' need for symptom management support: a randomized clinical trial. Journal of the American Medical Informatics Association 2010;17(4):403-10. - PMC - PubMed
Saitz 2003 {published data only}
    1. Saitz R, Horton NJ, Sullivan LM, Moskowitz MA, Samet JH. Addressing alcohol problems in primary care: a cluster randomized, controlled trial of a systems intervention. Annals of Internal Medicine 2003;138(5):372-82. - PubMed
Sandheimer 2020 {published data only}
    1. Sandheimer C, Hedenrud T, Hensing G, Holmgren K. Effects of a work stress intervention on healthcare use and treatment compared to treatment as usual: a randomised controlled trial in Swedish primary healthcare. BMC Family Practice 2020;21(1):133. - PMC - PubMed
Santana 2010 {published data only}
    1. Santana MJ, Feeny D, Johnson JA, McAlister FA, Kim D, Weinkauf J, et al. Assessing the use of health-related quality of life measures in the routine clinical care of lung-transplant patients. Quality of Life Research 2010;19(3):371-9. - PubMed
Scheidt 2012 {published data only}
    1. Scheidt CE, Brockmann J, Caspar F, Rudolf G, Stangier U, Vogel H. The project of the Techniker-Krankenkasse: some comments on the results by the project's scientific advisory board [Das modellprojekt der Techniker–Krankenkasse:eine kommentierung der ergebnisse aus der aicht deswissenschaftlichen projektbeirates]. PsychotherapiePsychosomatik Medizinische Psychologie 2012;62(11):405-12. - PubMed
Schmidt 2006 {published data only}
    1. Schmidt U, Landau S, Pombo-Carril MG, Bara-Carril N, Reid Y, Murray K, et al. Does personalized feedback improve the outcome of cognitive-behavioural guided self-care in bulimia nervosa? A preliminary randomized controlled trial. British Journal of Clinical Psychology 2006;45:111–21. - PubMed
Schottke 2019 {published data only}
    1. Schottke H, Unrath M, Uhlmann C. The effect of patient progress feedback on psychotherapy outcome. Verhaltenstherapie 2019;Online first. [DOI: 10.1159/000501176] - DOI
Schriger 2001 {published data only}
    1. Schriger DL, Gibbons PS, Langone CA, Lee S, Altshuler LL. Enabling the diagnosis of occult psychiatric illness in the emergency department: a randomized, controlled trial of the computerized, self-administered PRIME-MD diagnostic system. Annals of Emergency Medicine 2001;37(2):132-40. - PubMed
Schriger 2005 {published data only}
    1. Schriger DL, Gibbons PS, Nezami WA, Langone CA. Failure of a patient-centered intervention to substantially increase the identification and referral for-treatment of ambulatory emergency department patients with occult psychiatric conditions: a randomized trial. BMC Emergency Medicine 2005;5(1):2. - PMC - PubMed
Shapiro 1987 {published data only}
    1. Shapiro S, German PS, Skinner EA, VonKorff M, Turner RW, Klein LE, et al. An experiment to change detection and management of mental morbidity in primary care. Medical Care 1987;25(4):327-39. - PubMed
Simon 2012 {published data only}
    1. Simon W, Lambert MJ, Harris MW, Busath G, Vazquez A. Providing patient progress information and clinical support tools to therapists: effects on patients at risk of treatment failure. Psychotherapy Research 2012;22(6):638-47. - PubMed
Simons 2015 {published data only}
    1. Simons CJ, Hartmann JA, Kramer I, Menne-Lothmann C, Hohn P, Bemmel AL, et al. Effects of momentary self-monitoring on empowerment in a randomized controlled trial in patients with depression. European Psychiatry 2015;30(8):900-6. - PubMed
    1. Simons CJP, Drukker M, Evers S, van Mastrigt Gapg, Hohn P, Kramer I, et al. Economic evaluation of an experience sampling method intervention in depression compared with treatment as usual using data from a randomized controlled trial. BMC Psychiatry 2017;17(1):415. - PMC - PubMed
Slade 2006a {published data only}
    1. Slade M, Leese M, Gilldard M, Kuipers E, Thornicroft G. Pre-morbid IQ and response to routine outcome assessment. Psychological Medicine 2006;36:1183–91. - PubMed
Slade 2006b {published data only}
    1. Slade M, McCrone P, Kuipers E, Leese M, Cahill S, Parabiaghi A, et al. Use of standardised outcome measures in adult mental health services: randomised controlled trial. British Journal of Psychiatry 2006;189:330-6. - PubMed
Strasser 2016 {published data only}
    1. Strasser F, Blum D, Moos R, Cathomas R, Ribi K, Aebi S, et al. The effect of real-time electronic monitoring of patient-reported symptoms and clinical syndromes in outpatient workflow of medical oncologists: E-MOSAIC, a multicenter cluster-randomized phase III study (SAKK 95/06). Annals of Oncology 2016;27(2):324-32. - PubMed
Stuck 2015 {published data only}
    1. Stuck AE, Moser A, Morf U, Wirz U, Wyser J, Gillmann G, et al. Effect of health risk assessment and counselling on health behaviour and survival in older people: a pragmatic randomised trial. PLOS Medicine 2015;12(10). - PMC - PubMed
Subramanian 2004 {published data only}
    1. Subramanian U, Fihn SD, Weinberger M, Plue L, Smith FE, Udris EM, et al. A controlled trial of including symptom data in computer-based care suggestions for managing patients with chronic heart failure. American Journal of Medicine 2004;116(6):375-84. - PubMed
Thomas 2016 {published data only}
    1. Thomas RE, Spragins W, Mazloum G, Cronkhite M, Maru G. Rates of detection of developmental problems at the 18-month well-baby visit by family physicians' using four evidence-based screening tools compared to usual care: a randomized controlled trial. Child: Care, health and Development 2016;42(3):382-93. - PubMed
Tolstrup 2020 {published data only}
    1. Tolstrup LK, Bastholt L, Dieperink KB, Möller S, Zwisler AD, Pappot H. The use of patient-reported outcomes to detect adverse events in metastatic melanoma patients receiving immunotherapy: a randomized controlled pilot trial. Journal of Patient Reported Outcomes. 2020;4:88. - PMC - PubMed
    1. Tolstrup LK, Pappot H, Dieperink KB, Zwisler A-DO, Bastholt L. PRO-CTCAE in the management of adverse effects in patients receiving immunotherapy for metastatic melanoma-an ongoing randomized clinical trial. ISOQOL International Conference. 2018;27:S76‐S77.
Trowbridge 1997 {published data only}
    1. Trowbridge R, Dugan W, Jay SJ, Littrell D, Casebeer LL, Edgerton S, et al. Determining the effectiveness of a clinical-practice intervention in improving the control of pain in outpatients with cancer. Academic Medicine 1997;72(9):798-800. - PubMed
Trudeau 2001 {published data only}
    1. Trudeau LS. Effects of a clinical feedback system on client and therapist outcomes in a rural community mental health center. Retrospective Theses and Dissertations 2000;Paper 12367.
Valles 2017 {published data only}
    1. Valles MM, Comos JB, Perez J, Corripio R, Carreras G, Herrero X, et al. 'Impact of monitoring health-related quality of life in clinical practice in children with type 1 diabetes mellitus'. Quality of Life Research 2017;26(2):3267-77. - PubMed
van der Hout 2020 {published data only}
    1. Hout A, Jansen F, Uden-Kraan CF, Coupe VM, Holtmaat K, Nieuwenhuijzen GA, et al. Cost-utility of an eHealth application 'Oncokompas' that supports cancer survivors in self-management: results of a randomised controlled trial. Journal of Cancer Survivorship 2021;15:77-86. - PMC - PubMed
    1. Hout A, Uden-Kraan CF, Holtmaat K, Jansen F, Lissenberg-Witte BI, Nieuwenhuijzen GA, et al. Role of eHealth application Oncokompas in supporting self-management of symptoms and health-related quality of life in cancer survivors: a randomised, controlled trial. Lancet Oncology 2020;21(1):80-94. - PubMed
van Dijk‐de Vries 2015 {published data only}
    1. Dijk-de Vries A, Bokhoven MA, Winkens B, Terluin B, Knottnerus JA, Weijden T, et al. Lessons learnt from a cluster-randomised trial evaluating the effectiveness of Self-Management Support (SMS) delivered by practice nurses in routine diabetes care. BMJ Open 2015;5:e007014. - PMC - PubMed
van Os 2003 {published data only}
    1. Van Os J, Altamura AC, Bobes J, Gerlach J, Hellewell JS, Kasper S, et al. Evaluation of the Two-Way Comminication Checklist as a clinical intervention. British Journal of Psychiatry 2004;184:79-83. - PubMed
Velikova 2004 {published data only}
    1. Velikova G, Booth L, Smith AB, Brown PM, Lynch P, Brown JM, et al. Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial. Journal of Clinical Oncology 2004;22(4):714-24. - PubMed
    1. Velikova G, Keding A, Harley C, Cocks K, Booth L, Smith AB, et al. Patients report improvements in continuity of care when quality of life assessments are used routinely in oncology practice: secondary outcomes of a randomised controlled trial. European Journal of Cancer 2010;13:2381-8. - PubMed
Wagner 1997 {published data only}
    1. Wagner AK, Ehrenberg BL, Tran TA, Bungay KM, Cynn DJ, Rogers WH. Patient-based health status measurement in clinical practice: A study of its impact on epilepsy patients’ care. Quality of Life Research 1997;6(4):329-41. - PubMed
Wasson 1992 {published data only}
    1. Wasson J, Hays R, Rubenstein L, Nelson E, Leaning J, Johnson D, et al. The short-term effect of patient health status assessment in a health maintenance organization. Quality of Life Research 1992;1(2):99-106. - PubMed
Wheelock 2015 {published data only}
    1. Wheelock AE, Bock MA, Martin EL, Hwang J, Ernest ML, Rugo HS, et al. SIS.NET: a randomized controlled trial evaluating a web-based system for symptom management after treatment of breast cancer. Cancer 2015;121(6):893-9. - PubMed
Whipple 2003 {published data only}
    1. Whipple JL, Lambert MJ, Vermeersch DA, Smart DW, Nielsen SL, Hawkins EJ. Improving the effects of psychotherapy: The use of early identification of treatment and problem-solving strategies in routine practice. Journal of Counseling Psychology 2003;50(1):59-68.
White 1995 {published data only}
    1. White P, Atherton A, Hewett G, Howells K. Using information from asthma patients: a trial of information feedback in primary care. BMJ 1995;311(7012):1065–9. - PMC - PubMed
Whooley 2000 {published data only}
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Wikberg 2017 {published data only}
    1. Wikberg C, Westman J, Petersson EL, Larsson ME, Andre M, Eggertsen R, et al. Use of a self-rating scale to monitor depression severity in recurrent GP consultations in primary care - does it really make a difference? A randomised controlled study. BMC Family Practice 2017;18(1):6. - PMC - PubMed
Williams 1990 {published data only}
    1. Williams JW, Mulrow CD, Kroenke K, Dhanda R, Badgett RG, Omori D, et al. Case-finding for depression in primary care: A randomized trial. American Journal of Medicine 1999;106(1):36-43. - PubMed
Wolfe 2014 {published data only}
    1. Wolfe J, Orellana L, Cook EF, Ullrich C, Kang T, Geyer JR, et al. Improving the care of children with advanced cancer by using an electronic patient-reported feedback intervention: results from the PediQUEST randomized controlled trial. Journal of Clinical Oncology 2014;32(11):1119–26. - PMC - PubMed
Yager 1981 {published data only}
    1. Yager J, Linn LS. Physician-patient agreement about depression: notation in medical records. General Hospital Psychiatry 1981;3(4):271-6. - PubMed
Zung 1983 {published data only}
    1. Zung WW, Magill M, Moore JT, George DT. Recogntion and treatment of depression in a family medical practice. Journal of Clinical Psychiatry 1983;44(1):3-6. - PubMed

References to studies excluded from this review

Aakhus 2016 {published data only}
    1. Aakhus E, Granlund I, Odgaard-Jensen J, Oxman AD, Flottorp SA. A tailored intervention to implement guideline recommendations for elderly patients with depression in primary care: a pragmatic cluster randomised trial. Implementation Science 2016;11:32. [DOI: 10.1186/s13012-016-0397-3] - DOI - PMC - PubMed
Aardoom 2016 {published data only}
    1. Aardoom JJ, Dingemans AE, Spinhoven P, Ginkel JR, Rooij M, Furth EF. Web-based fully automated self-help with different levels of therapist support for individuals with eating disorder symptoms: a randomized controlled trial. Journal of Medical Internet Research 2016;18(6):e159. - PMC - PubMed
    1. Aardoom JJ, Dingemans AE, Ginkel JR, Spinhoven P, Van Furth EF, Van den Akker-van Marle ME. Cost-utility of an internet-based intervention with or without therapist support in comparison with a waiting list for individuals with eating disorder symptoms: a randomized controlled trial. International Journal of Eating Disorders 2016;49(12):1068-76. - PubMed
Adamowicz 2017 {published data only}
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Adams 2015 {published data only}
    1. Adams J, Cymbala AA, Delate T, Kurz D, Olson KL, Zadvorny E. Cluster-randomized trial of clinical pharmacist tobacco cessation counseling among patients with cardiovascular disease. Population Health Management 2015;18(4):300‐6. [DOI: 10.1089/pop.2014.0106] - DOI - PubMed
Adams 2016 {published data only}
    1. Adams AS, Bayliss EA, Schmittdiel JA, Altschuler A, Dyer W, Neugebauer R, et al, Diabetes Telephone Study Team. The Diabetes Telephone Study: Design and challenges of a pragmatic cluster randomized trial to improve diabetic peripheral neuropathy treatment. Clinical Trials 2016;13(3):286-93. [DOI: 10.1177/1740774516631530] - DOI - PMC - PubMed
Ahmed 2016 {published data only}
    1. Ahmed S, Ernst P, Bartlett SJ, Valois MF, Zaihra T, Pare G, et al. The effectiveness of web-based asthma self-management system, My aAsthma Portal (MAP): A pilot randomized controlled trial. Journal of Medical Internet Research 2016;18(12):e313. - PMC - PubMed
Al Jundi 2016 {published data only}
    1. Al-Jundi W, Elsharif M, Anderson M, Chan P, Beard J, Nawaz S. A randomized controlled trial to compare e-feedback versus standard face-to-face verbal feedback to improve the acquisition of procedural skill. Journal of Surgical Education 2016;(no pagination). [DOI: 10.1016/j.jsurg.2016.11.011] - DOI - PubMed
Anderson 2018 {published data only}
    1. Anderson M, Rallapalli V, Schoof T, Souza P, Arehart K. The use of self-report measures to examine changes in perception in response to fittings using different signal processing parameters. International Journal of Audiology 2018;57(11):1-7. [DOI: 10.1080/14992027.2018.1490035] - DOI - PMC - PubMed
Baron 2017 {published data only}
    1. Baron JS, Hirani SP, Newman SP. Investigating the behavioural effects of a mobile-phone based home telehealth intervention in people with insulin-requiring diabetes: results of a randomized controlled trial with patient interviews. Journal of Telemedicine and Telecare 2017;23(5):503-12. [DOI: 10.1177/1357633X16655911] - DOI - PubMed
Baron 2017a {published data only}
    1. Baron JS, Hirani S, Newman SP. A randomised, controlled trial of the effects of a mobile telehealth intervention on clinical and patient-reported outcomes in people with poorly controlled diabetes. Journal of Telemedicine and Telecare 2017;23(2):207-216. [DOI: 10.1177/1357633X16631628] - DOI - PubMed
Boogaard 2018 {published data only}
    1. Boogaard JA, Vet HC, Soest-Poortvliet MC, Anema JR, Achterberg WP, Steen JT. Effects of two feedback interventions on end-of-life outcomes in nursing home residents with dementia: a cluster-randomized controlled three-armed trial. Palliative Medicine 2018;32(3):693-702. [DOI: 10.1177/0269216317750071] - DOI - PMC - PubMed
Boyce 2018 {published data only}
    1. Boyce MB, Browne JP. The effectiveness of providing peer benchmarked feedback to hip replacement surgeons based on patient-reported outcome measures—results from thePROFILE (Patient-ReportedOutcomes: Feedback Interpretation and LearningExperiment) trial: a cluster randomised controlled study.. BMJ Open 2015;5:e008325. - PMC - PubMed
Carlson 2010 {published data only}
    1. Carlson LE, Groff SL, Maciejewski O, Bultz BD. Screening for distress in lung and breast cancer outpatients: a randomized controlled trial. Journal of Clinical Oncology 2010;28(33):4884-91. - PubMed
Cook 2016 {published data only}
    1. Cook CM, Suhr JA. Effects of screening for postconcussive syndrome (PCS) on PCS symptom self-report and neuropsychological test performance. Clinical Neuropsychologist 2016;30(2):284-300. [DOI: 10.1080/13854046.2016.1139186] - DOI - PubMed
Cruickshank 2015 {published data only}
    1. Cruickshank S, Barber M, Donaldson J, Raeside R, Gray M. A randomised controlled trial to assess the effectivensss of using patient reported needs and psychological information to guide care in a breast cancer follow-up clinic. Cancer Nursing 2015;38(4 SUPPL. 1):S34‐S35. [DOI: 10.1097/NCC.0000000000000287] - DOI
Curtis 2018 {published data only}
    1. Curtis JR, Downey L, Back AL, Nielsen EL, Paul S, Lahdya AZ, et al. Effect of a patient and clinician communication-priming intervention on patient-reported goals-of-care discussions between patients with serious illness and clinicians: a randomized clinical trial. JAMA Internal Medicine 2018;178(7):930-40. [DOI: 10.1001/jamainternmed.2018.2317] - DOI - PMC - PubMed
daSilvaRibeiro 2015 {published data only}
    1. da Silva Ribeiro NM, Ferraz DD, Pedreira E, Pinheiro I, da Silva Pinto AC, Neto MG, et al. Virtual rehabilitation via Nintendo Wii and conventional physical therapy effectively treat post-stroke hemiparetic patients. Topics in Stroke Rehabilitation 2015;22(4):299-305. [DOI: 10.1179/1074935714Z.0000000017] - DOI - PubMed
Davidson 2017 {published data only}
    1. Davidson KM, Rankin ML, Begley A, Lloyd S, Barry SJ, McSkimming P, et al. Assessing patient progress in psychological therapy through feedback in supervision: the MeMOS randomized controlled trial (Measuring and Monitoring clinical Outcomes in Supervision: MeMOS). Behavioural and Cognitive Psychotherapy 2017;45(3):209-24. [DOI: 10.1017/S1352465817000029] - DOI - PubMed
Dougados 2015 {published data only}
    1. Dougados M, Soubrier M, Perrodeau E, Gossec L, Fayet F, Gilson M, et al. Impact of a nurse-led programme on comorbidity management and impact of a patient self-assessment of disease activity on the management of rheumatoid arthritis: results of a prospective, multicentre, randomised, controlled trial (COMEDRA). Annals of the Rheumatic Diseases 2015;74(9):1725‐33. [DOI: 10.1136/annrheumdis-2013-204733] - DOI - PMC - PubMed
Freyer Adam 2018 {published data only}
    1. Freyer-Adam J, Baumann S, Haberecht K, Tobschall S, Bischof G, John U, Gaertner B. In-person alcohol counseling versus computer-generated feedback: results from a randomized controlled trial. Health Psychology 2018;37(1):70-80. [DOI: 10.1037/hea0000556] - DOI - PubMed
Friedly 2016 {published data only}
    1. Friedly JL, Edwards T, Lavallee D, Bauer Z, Makris U, Nedeljkovic S, et al. Does provision of individualized reports showing changes in pain and function after epidural steroid injections (ESI) alter decision-making about future ESI use? PM & R 2016;8(9 Supplement):S309. - PubMed
Gallo 2016 {published data only}
    1. Gallo JJ, Hwang S, Joo JH, Bogner HR, Morales KH, Bruce ML, et al. Multimorbidity, depression, and mortality in primary care: Randomized clinical trial of an evidence-based depression care management program on mortality risk. Journal of General Internal Medicine 2016;31(4):380-6. [DOI: 10.1007/s11606-015-3524-y] - DOI - PMC - PubMed
Gossec 2016 {published data only}
    1. Gossec L, Servy H, Soubrier M, Joubert J-M, Czarlewski W, Combe B, et al. Access to an active, interactive self-assessment e-health platform improves patient-physician communication in rheumatoid arthritis: results of a randomized controlled trial including 320 patients over 1 year. Arthritis and Rheumatology 2016;68:1770‐1. [DOI: 10.1002/art.39977] - DOI
Graetz 2018 {published data only}
    1. Graetz I, Anderson JN, McKillop CN, Stepanski EJ, Paladino AJ, Tillmanns TD. Use of a web-based app to improve postoperative outcomes for patients receiving gynecological oncology care: a randomized controlled feasibility trial. Gynecologic Oncology 2018;150(2):311-7. [DOI: ] - PubMed
Hanling 2016 {published data only}
    1. Hanling SR, Hickey A, Lesnik I, Hackworth RJ, Stedje-Larsen E, Drastal CA, et al. Stellate ganglion block for the treatment of Posttraumatic Stress Disorder: a randomized, double-blind, controlled trial. Regional Anesthesia and Pain Medicine 2016;41(4):494‐500. [DOI: 10.1097/AAP.0000000000000402] - DOI - PubMed
Indovina 2016 {published data only}
    1. Indovina K, Keniston A, Reid M, Sachs K, Zheng C, Tong A, et al. Real-time patient experience surveys of hospitalized medical patients. Journal of Hospital Medicine 2016;11(4):251-6. [DOI: 10.1002/jhm.2533] - DOI - PubMed
Jaeger 2017 {published data only}
    1. Jaeger VK, Schiffer P, Zufferey P, Pichler L, Badaracco A, Walder M, et al. Patient's self-monitoring of disease activity of rheumatic diseases via webapp-study design, patient's perspective and recruitment in the first 11 months of the Swiss multicentre, longitudinal compass ii study. Annals of the Rheumatic Diseases 2017;76(Suppl 2):1445.
Janse 2015 {published data only}
    1. Janse A, Worm-Smeitink M, Bussel-Lagarde J, Bleijenberg G, Nikolaus S, Knoo H. Testing the efficacy of web-based cognitive behavioural therapy for adult patients with chronic fatigue syndrome (CBIT): study protocol for a randomized controlled trial. BMC Neurology 2015;15(1). [DOI: 10.1186/s12883-015-0392-3] - DOI - PMC - PubMed
Janssens 2015 {published data only}
    1. Janssens T, Harver A. Effects of symptom perception interventions on trigger identification and quality of life in children with asthma. Pulmonary Medicine 2015;2015(no pagination). [DOI: 10.1155/2015/825137] - DOI - PMC - PubMed
Jones 2016 {published data only}
    1. Jones F, Gage H, Drummond A, Bhalla A, Grant R, Lennon S, et al. Feasibility study of an integrated stroke self-management programme: a cluster-randomised controlled trial. BMJ Open 2016;6 (1) (no pagination)(e008900). [DOI: 10.1136/bmjopen-2015-008900] - DOI - PMC - PubMed
Kesanen 2017 {published data only}
    1. Kesanen J, Leino-Kilpi H, Lund T, Montin L, Puukka P, Valkeapaa K. Increased preoperative knowledge reduces surgery-related anxiety: a randomised clinical trial in 100 spinal stenosis patients. European Spine Journal 2017;26(10):1‐9. [DOI: 10.1007/s00586-017-4963-4] - DOI - PubMed
Kwan 2017 {unpublished data only}
    1. Kwan WMC. A randomized control trial to evaluate the effectiveness of short-term life review intervention in enhancing spiritual well-being and lowering anxiety and depression in palliative patients. ProQuest Dissertations Publishing 2017.
Liimatta 2017 {published data only}
    1. Liimatta H, Lampela P, Laitinen-Parkkonen P, Pitkala KH. Preventive home visits to promote the health-related quality of life of home-dwelling older people: baseline findings and feasibility of a randomized, controlled trial. European Geriatric Medicine 2017;8:440-5. [DOI: 10.1016/j.eurger.2017.06.003] - DOI
Lowenstein 2018 {published data only}
    1. Lowenstein LM, Escoto KH, Leal VB, Bailey L, Bevers TB, Cantor SB, et al. Randomized trial of a patient-centered decision aid for promoting informed decisions about lung cancer screening: Implementation of a PCORI study protocol and lessons learned. Contemporary Clinical Trials 2018;72:26-34. [DOI: 10.1016/j.cct.2018.07.007] - DOI - PMC - PubMed
McCombie 2020 {published data only}
    1. McCombie A, Walmsley R, Barclay M, Ho C, Langlotz T, Regenbrecht H, et al. A noninferiority randomized clinical trial of the use of the smartphone-based health applications IBDsmart and IBDoc in the care of inflammatory bowel disease patients. Inflamatory Bowel Diseases 2020;26(7):1098-109. - PubMed
Mooney 2015 {published data only}
    1. Mooney K, Blaz J, Donaldson G. Reducing family caregiver psychosocial distress through automated remote home monitoring and self-care coaching. Psycho-oncology 2015;24:194. [DOI: 10.1002/pon.3874] - DOI
Murff 2017 {published data only}
    1. Murff HJ. Self-monitoring of blood glucose did not improve HbA1c or QoL at 1 year in non-insulin-treated type 2 diabetes. Annals of Internal Medicine 2017;167(8):JC46. [DOI: 10.7326/ACPJC-2017-167-8-046] - DOI - PubMed
Olson 2017 {published data only}
    1. Olson D, Lamb M, Lopez MR, Colborn K, Paniagua-Avila A, Zacarias A, et al. Performance of a mobile phone app-based participatory syndromic surveillance system for acute febrile illness and acute gastroenteritis in rural Guatemala. Journal of Medical Internet Research 2017;19(11):e368. [DOI: 10.2196/jmir.8041] - DOI - PMC - PubMed
Paterson 2017 {published data only}
    1. Paterson C, Primeau C, Nabi G. A multimodal supportive care intervention in men and their partners/carers affected by metastatic prostate cancer: a randomised controlled feasibility study. European Urology 2017;16(3):e1641. [DOI: 10.1016/S1569-9056%2817%2930992-2] - DOI
Piette 2015 {published data only}
    1. Piette JD, Striplin D, Marinec N, Chen J, Trivedi RB, Aron DC, et al. A mobile health intervention supporting heart failure patients and their informal caregivers: a randomized comparative effectiveness trial. Journal of Medical Internet Research 2015;17(6):e142. - PMC - PubMed
Riese 2015 {published data only}
    1. Riese A, Mello MJ, Baird J, Steele DW, Ranney ML. Prompting discussions of youth violence using electronic previsit questionnaires in primary care: a cluster randomized trial. Academic Pediatrics 2015;15(3):345-52. - PubMed
Roberts 2017 {published data only}
    1. Roberts W, Fillmore MT. Curbing the DUI offender's self-efficacy to drink and drive: a laboratory study. Drug and Alcohol Dependence 2017;172:73-9. [DOI: 10.1016/j.drugalcdep.2016.12.005] - DOI - PMC - PubMed
Sanchez 2018 {published data only}
    1. Sanchez R, Mateo KF. Survey-based priming intervention linked to improved communication with the seriously Ill. Journal of Clinical Outcomes Management 2018;25(7):300-3.
Sepucha 2019 {published data only}
    1. Sepucha K, Bedair H, Yu L, Dorrwachter JM, Dwyer M, Talmo CT, et al. Decision support strategies for hip and knee osteoarthritis: less is more: a randomized comparative effectiveness trial (DECIDE-OA Study). Journal of Bone and Joint Surgery: American volume. 2019;101(18):1645-53. - PMC - PubMed
Skinner 2016 {published data only}
    1. Skinner CS, Gupta S, Bishop WP, Ahn C, Tiro JA, Halm EA, et al. Tailored information increases patient/physician discussion of colon cancer risk and testing: the Cancer Risk Intake System trial. Preventive Medicine Reports 2016;4:6-10. [DOI: 10.1016/j.pmedr.2016.04.008] - DOI - PMC - PubMed
Smith 2018 {published data only}
    1. Smith A, Pennington A, Carter B, Gething S, Price M, White J, et al. Acceptability of the method of administration of a patient-reported outcome measure (PROM) with stroke survivors, a randomised controlled trial protocol. Trials 2018;19(1):349. [DOI: 10.1186/s13063-018-2694-4] - DOI - PMC - PubMed
Sonal Sekhar 2018 {published data only}
    1. Sonal Sekhar M, Unnikrishnan MK, Vijayanarayana K, Rodrigues GS. Impact of patient-education on health related quality of life of diabetic foot ulcer patients: a randomized study. Clinical Epidemiology and Global Health 2018. [DOI: 10.1016/j.cegh.2018.07.009] - DOI
Stump 2017 {published data only}
    1. Stump TK. Daily feedback improves sun protection among patients with an elevated risk of skin cancer. Dissertation Abstracts International: Section B: The Sciences and Engineering 2017;78(4-B(E)):No Pagination Specified.
Szots 2016 {published data only}
    1. Szots K, Konradsen H, Solgaard S, Ostergaard B. Telephone follow-up by nurse after total knee arthroplasty: results of a randomized clinical trial. Orthopaedic Nursing 2016;35(6):411-20. - PubMed
Uchitomi 2015 {published data only}
    1. Uchitomi Y, Fujimori M. Effect of communication skills training program for oncologists based on patient preferences for communication when receiving bad news: a randomized controlled trial. Supportive Care in Cancer 2015;23(1 SUPPL. 1):S239. [DOI: 10.1007/s00520-015-2712-y] - DOI - PubMed
Valle 2018 {published data only}
    1. Valle CG, Queen TL, Martin BA, Ribisl KM, Mayer DK, Tate DF. Optimizing tailored communications for health risk assessment: a randomized factorial experiment of the effects of expectancy priming, autonomy support, and exemplification. Journal of Medical Internet Research 2018;20(3):e63. [DOI: 10.2196/jmir.7613] - DOI - PMC - PubMed
vanderWeegen 2015 {published data only}
    1. Weegen S, Verwey R, Spreeuwenberg M, Tange H, Weijden T, Witte L. It's LiFe! Mobile and web-based monitoring and feedback tool embedded in primary care increases physical activity: a cluster randomized controlled trial. Journal of Medical Internet Research 2015;17(7):e184. [DOI: 10.2196/jmir.4579] - DOI - PMC - PubMed
vanDijk 2015 {published data only}
    1. Dijk ET, Westerink JHD, Beute F, Ijsselsteijn WA. In Sync: the effect of physiology feedback on the match between heart rate and self-reported stress. BioMed Research International 2015;2015:1-9. [DOI: 10.1155/2015/134606] - DOI - PMC - PubMed
Voruganti 2017 {published data only}
    1. Voruganti T, Grunfeld E, Jamieson T, Kurahashi AM, Lokuge B, Krzyzanowska MK, et al. My Team of Care Study: a pilot randomized controlled trial of a web-based communication tool for collaborative care in patients with advanced cancer. Journal of Medical Internet Research 2017;19(7):e219. [DOI: 10.2196/jmir.7421] - DOI - PMC - PubMed
Weiss 2019 {published data only}
    1. Weiss ME, Yakusheva O, Bobay KL, Costa L, Hughes RG, Nuccio S, et al, READI Site Investigators. Effect of implementing discharge readiness assessment in adult medical-surgical units on 30-day return to hospital: the READI randomized clinical trial. JAMA Network Open 2019;2(1):e187387. - PMC - PubMed
Williamson 2015 {published data only}
    1. Williamson S, Beaver K, Martin-Hirsch P, Patrick K, Anne T, Sutton C. Comparing hospital and telephone follow-up for women treated for endometrial cancer (ENDCAT trial). European Journal of Cancer 2015;51:S251.
Wright 2018 {published data only}
    1. Wright C, Dietze PM, Agius PA, Kuntsche E, Livingston M, Black OC, et al. Mobile phone-based ecological momentary intervention to reduce young adults' alcohol use in the event: a three-armed randomized controlled trial. JMIR Mhealth and Uhealth 2018;6(7):e149. [DOI: ] - PMC - PubMed
Yee 2017 {published data only}
    1. Yee R, Jones L, Hosey M. What the child "SAID" to the dentist: a UK randomized controlled trial. Child: Care, Health and Development 2017;43(6):926-32. [DOI: 10.1111/cch.12510] - DOI - PubMed

References to studies awaiting assessment

Castillo 2017 {published data only}
    1. Castillo C, Alfonzo AL, Camejo N, Schiavone A, Diaz M, Camano I, et al. Impact of measuring quality of life in oncology practice: a prospective study. Journal of Cinical Oncology 2017;35(15 Supplement 1):(no pagination).

References to ongoing studies

Absolom 2017 {published data only}
    1. Absolom K, Holch P, Warrington L, Samy F, Hulme C, Hewison J, et al, Rapid Systemic Treatment Work Group. Electronic patient self-Reporting of Adverse-events: patient Information and aDvice (eRAPID): a randomised controlled trial in systemic cancer treatment. BMC Cancer 2017;17(1):318. [DOI: 10.1186/s12885-017-3303-8] - DOI - PMC - PubMed
ACTRN12619001126101 {published data only}
    1. ACTRN12619001126101. PROpatient: Can symptom monitoring and care coordination improve the quality of life of people with upper gastrointestinal cancer? anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378002 (first received 18 July 2019).
ACTRN12620000174987 {published data only}
    1. ACTRN12620000174987. Using responses to child and caregiver questionnaires about quality of life in hospital consultations. anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12620000174987 (first received 23 January 2020).
Arts 2017 {published data only}
    1. Arts LP van de Poll-Franse LV, den Berg SW, Prins JB, Husson O, Mols F, et al. Lymphoma InterVEntion (LIVE) - patient-reported outcome feedback and a web-based self-management intervention for patients with lymphoma: study protocol for a randomised controlled trial. Trials 2017;18(1) (no pagination). [DOI: 10.1186/s13063-017-1943-2] - DOI - PMC - PubMed
Atreja 2016 {published data only}
    1. Atreja A, Khan S, Rogers JD, Otobo E, Patel NP, Ullman T, et al. Impact of the Mobile HealthPROMISE Platform on the quality of care and quality of life in patients with inflammatory bowel disease: study protocol of a pragmatic randomized controlled trial. JMIR Research Protocols 2015;150(4 SUPPL. 1):S1000. - PMC - PubMed
Bansback 2019 {published data only}
    1. Bansback N, Trenaman L, MacDonald KV, Hawker G, Johnson JA, Stacey D, et al. An individualized patient-reported outcome measure (PROM) based patient decision aid and surgeon report for patients considering total knee arthroplasty: protocol for a pragmatic randomized controlled trial. BMC Musculoskeletal Disorders 2019;20(1):89. - PMC - PubMed
Bubb 2018 {published data only}
    1. Bubb MR, Judd R, Chauffe AD. Incorporation of patient reported outcomes data in the care of us veterans with rheumatoid arthritis: a randomized, controlled trial. Arthritis and Rheumatology 2018;70:3228-9.
ChiCTR1800018769 {published data only}
    1. ChiCTR1800018769. The application of patient reported outcomes in preventing relapse of depression. www.chictr.org.cn/showprojen.aspx?proj=31602 (first received 09 October 2018).
ChiCTR1900020846 {published data only}
    1. ChiCTR1900020846. Using patient-reported outcomes to manage postoperative symptoms in patients with lung cancer: a multicentre, randomised controlled trial. www.chictr.org.cn/hvshowproject.aspx?id=62679 (first received 22 November 2018).
    1. Dai W, Zhang Y, Feng W, Liao X, Mu Y, Zhang R, et al. Using patient-reported outcomes to manage postoperative symptoms in patients with lung cancer: protocol for a multicentre, randomised controlled trial. BMJ Open 2019;9:e030041. [DOI: 10.1136/bmjopen-2019-030041] - DOI - PMC - PubMed
Gorini 2016 {published data only}
    1. Gorini A, Mazzocco K, Kondylakis H, McVie G, Pravettoni G. A web-based interactive tool to improve breast cancer patient centredness. ecancermedicalscience 2016;10 (no pagination)(659). [DOI: 10.3332/ecancer.2016.659] - DOI - PMC - PubMed
Grove 2018 {published data only}
    1. Grove B, Ivarsen P, De Thurah A, Kyte D, Henrik HN. Remote follow-up using patient-reported outcome measures in patients with chronic kidney disease: the PROKID study – study protocol for a non-inferiority pragmatic randomised controlled trial. BMC Health Services Research 2019;19:S143‐S144. - PMC - PubMed
Grove 2019 {published data only}
    1. Grove B, Ivarsen P, De Thurah A, Kyte D, Henrik HN. Tele follow-up using patient-reported outcomes (PRO) measures in patients with chronic kidney disease-the PRO-KID study: a study protocol for a non-inferiority randomised controlled trial in Denmark. Quality of Life Research 2018;27:S143-4.
    1. Grove BE, Ivarsen P, Thurah A, Schougaard LM, Kyte D, Hjollund NH. Remote follow-up using patient-reported outcome measures in patients with chronic kidney disease: the PROKID study – study protocol for a non-inferiority pragmatic randomised controlled trial. BMC Health Services Research 2019;19:631. - PMC - PubMed
Holch 2018 {published data only}
    1. Holch P, Pini S, Henry AM, Davidson S, Routledge J, Brown J, et al, Rapid radiotherapy work group. eRAPID electronic patient self-Reporting of Adverse-events: Patient Information and aDvice: a pilot study protocol in pelvic radiotherapy. Pilot and Feasibility Studies 2018;4:110. [DOI: 10.1186/s40814-018-0304-6] - DOI - PMC - PubMed
ISRCTN82172279 {published data only}
    1. ISRCTN82172279 Reconceptualising patient-reported outcome measures for back pain. ISRCTN Registry. [DOI: ]
Kendrick 2020 {published data only}
    1. ISRCTN17299295. Patient-reported outcome measures for monitoring primary care patients with depression: PROMDEP randomised controlled trial. www.isrctn.com/ISRCTN17299295 (first received 1 January 2018).
    1. Kendrick T, Moore M, Leydon G, Stuart B, Geraghty AW, Yao G, et al. Patient-reported outcome measures for monitoring primary care patients with depression (PROMDEP): study protocol for a randomised controlled trial. Trials 2020;21(1):441. - PMC - PubMed
Klinkhammer‐Schalke 2015 {published data only}
    1. Klinkhammer-Schalke M, Lindberg P, Koller M, Wyatt JC, Hofstädter F, Lorenz W, et al. Direct improvement of quality of life in colorectal cancer patients using a tailored pathway with quality of life diagnosis and therapy (DIQOL): study protocol for a randomised controlled trial. Trials 2015;16:460. [DOI: 10.1186/s13063-015-0972-y] - DOI - PMC - PubMed
    1. Lindberg P, Steinger B, Koller M, Furst A, Kastel M, Obermaier R, et al. Implementing a clinical pathway with quality of life diagnosis and therapy of patients with primary colorectal cancer: A randomised controlled trial. Oncology Research and Treatment 2016;39:137. [DOI: 10.1159/000444354] - DOI
Kuklinski 2020 {published data only}
    1. DRKS00019916. PROMoting Quality - Intersectoral use of Patient Reported Outcome Measures to increase patient-relevant outcome quality. www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DR... 2019.
    1. Kuklinski D, Oschmann L, Pross C, Busse R, Geissler A. 2020. Trials 2020;21:322. - PMC - PubMed
Kyte 2018 {published data only}
    1. Kyte D, Nishop J, Brettell E, Calvert M, Cockwell P, Dutton M, et al. Use of an electronic patient-reported outcome measure in the management of patients with advanced chronic kidney disease: the RePROM pilot trial protocol. BMJ Open 2018;8(10):e026080. - PMC - PubMed
Mamguem Kanga 2020 {published data only}
    1. Mamguem Kamga A, Di Martino C, Anota A, Paget-Bailly S, Coutant C, Arveux P, et al. Impact of routine assessment of health-related quality of life coupled with therapeutic information on compliance with endocrine therapy in patients with non-metastatic breast cancer: protocol for a randomized controlled trial. Trials 2020;21(1):527. - PMC - PubMed
Matsuda 2018 {published data only}
    1. Matsuda A, Yamada Y, Ishizuka N, Matsushima E, Kobayashi K, Ohkubo T, et al. Effects of a self-monitoring quality of life intervention for patients with cancer receiving palliative care in Japan: study protocol for a randomized controlled trial. Asian Pacific Journal of Cancer Prevention 2018;19(11):3027-32. - PMC - PubMed
Morton 2019 {published data only}
    1. Morton R, Jose M, Brown C, Bennett P, Palmer S, Caskey F, et al. The symptom monitoring with feedback trial (Swift): a novel registry-based cluster randomised controlled trial among Australian and New Zealand adults with end-stage kidney disease managed on haemodialysis. Nephrology Dialysis Transplantation 2019;34(Suppl. 1):a13.
NCT02591472 {published data only}
    1. NCT02591472. An integrated-delivery-of-care approach to improve patient outcomes, safety, well-being after orthopaedic trauma. clinicaltrials.gov/ct2/show/NCT02591472 (first received 29 October 2015).
NCT02673580 {published data only}
    1. NCT02673580. Tele-patient-reported Outcomes (telePRO) in clinical practice. clinicaltrials.gov/ct2/show/NCT02673580 (first received 4 February 2016).
NCT02818478 {published data only}
    1. NCT02818478. Patient reported outcomes reported via PC/ tablet home versus touch screen at hospital among patients with arthritis (PRO). clinicaltrials.gov/ct2/show/NCT02818478 (first received 29 June 2016).
NCT02917954 {published data only}
    1. NCT02917954. Electronic patient reported outcome (ePRO) mobile application pragmatic trial. clinicaltrials.gov/ct2/show/NCT02917954 (first received 28 September 2016).
NCT02949167 {published data only}
    1. NCT02949167. MyHealth: follow-up after breast cancer treatment. clinicaltrials.gov/ct2/show/NCT02949167 (first received 31 October 2016).
NCT02996201 {published data only}
    1. NCT02996201. Electronic patient reporting of side effects to chemotherapy: a cluster randomized controlled trial. clinicaltrials.gov/ct2/show/NCT02996201 (first received 19 December 2016).
    1. Pappot H, Baeksted C, Knoop A, Mitchell SA, Nissen A, Johansen C. Routine surveillance for symptomatic toxicities with real-time clinician reporting in Danish breast cancer patients-Organization and design of the first national, cluster randomized trial using the Patient-Reported Outcomes version of Common Terminology C. Breast Journal 2019;25(2):269-272. - PubMed
NCT03056469 {published data only}
    1. NCT03056469. Patient-reported outcomes integrated in the follow-up of patients with hematological cancer. clinicaltrials.gov/ct2/show/NCT03056469 (first received 17 February 2017).
NCT03093649 {published data only}
    1. NCT03093649. Measuring patient-reported adverse events in oncology practice improves quality of life in nasopharyngeal carcinoma. clinicaltrials.gov/ct2/show/NCT03093649 (first received 28 March 2017).
NCT03202732 {published data only}
    1. NCT03202732. DiabetesFlex - Patient involvement and patient-reported outcome measures in Type 1 diabetes. clinicaltrials.gov/ct2/show/NCT03202732 (first received 29 June 2017).
NCT03240913 {published data only}
    1. NCT03240913. A PROMs based educational tool (PROM-DA) for patients considering total knee arthroplasty. clinicaltrials.gov/ct2/show/NCT03240913 (first received 7 August 2017).
NCT03249090 {published data only}
    1. NCT03249090. Electronic patient reporting of symptoms during cancer treatment (PRO-TECT). clinicaltrials.gov/ct2/show/NCT03249090 (first received 15 August 2017).
    1. Stover AM, Henson S, Deal AM, Stricker CT, Hammelef KJ, Bennett AV, et al. Methods for alerting clinicians to concerning symptom questionnaire responses during cancer care: approaches from two randomized trials (STAR, AFT-39 PRO-TECT). Journal of Clinical Oncology 2018;36:30.
NCT03471104 {published data only}
    1. NCT03471104. Patient-reported outcome measures in diabetes care (DiaPROM). clinicaltrials.gov/ct2/show/NCT03471104 (first received 20 March 2018).
NCT03535922 {published data only}
    1. NCT03535922. Evaluation of routinely measured patient-reported outcomes in hemodialysis care. clinicaltrials.gov/ct2/show/NCT03535922 (first received 24 May 2018).
NCT03608410 {published data only}
    1. NCT03608410. Intensified follow-up of lung cancer using weekly questionnaires via the Internet (ProWide). clinicaltrials.gov/ct2/show/NCT03608410 (first received 1 Augus 2018).
NCT03850912 {published data only}
    1. NCT03850912. Symptom Management Implementation of Patient Reported Outcomes in Oncology (SIMPRO). clinicaltrials.gov/ct2/show/NCT03850912 (first received 22 February 2019).
NCT03995082 {published data only}
    1. NCT03995082. Breast cancer patient engagement with patient reported outcome measure survey. clinicaltrials.gov/ct2/show/NCT03995082 (first received 21 June 2019).
NCT04066868 {published data only}
    1. NCT04066868. Evaluating the use of patient-reported outcome measures for improving the inter-rater reliability of common terminology criteria for adverse event ratings. clinicaltrials.gov/ct2/show/NCT04066868 (first received 26 August 2019).
NCT04069455 {published data only}
    1. NCT04069455. ePRO for adjuvant therapy of colorectal adenocarcinoma. clinicaltrials.gov/ct2/show/NCT04069455 (first received 28 August 2019).
NCT04164004 {published data only}
    1. NCT04164004. Patient-Reported Outcome Measurement in Heart Failure Clinic (PRO-HF). clinicaltrials.gov/ct2/show/NCT04164004 (first received 15 November 2019).
NCT04342260 {published data only}
    1. NCT04342260. Improving quality of life after thoracic surgery using patient-reported outcomes. clinicaltrials.gov/ct2/show/NCT04342260 (first received 10 April 2020).
NCT04356209 {published data only}
    1. NCT04356209. Improving The empowerment inpatients with severe breast fibrosis radio-induced treated by pravastatin: benefit of e-PROs (Electronic " Patient Reported Outcome ") on breast-related quality of life (PRAVACUR-02). clinicaltrials.gov/ct2/show/NCT04356209 (first received April 2020).
NCT04393571 {published data only}
    1. NCT04393571. The utility of mobile based patient reported outcome measures in patients with acetabular fractures: a randomized controlled trial. clinicaltrials.gov/ct2/show/NCT04393571 (first received 19 May 2020).
NCT04401332 {published data only}
    1. NCT04401332. A randomized controlled trial of AppS To Home Monitor your Asthma (ASTHMA). clinicaltrials.gov/ct2/show/NCT04401332 (first received 26 May 2020).
NCT04492007 {published data only}
    1. NCT04492007. Feasibility Testing of Patient Reported Outcomes - Informed Symptom Management System (PRISMS). clinicaltrials.gov/ct2/show/NCT04492007 (firs received 30 July 2020).
Paladino 2019 {published data only}
    1. Paladino AJ, Anderson JN, Krukowski RA, Waters T, Kocak M, Graff C, et al. THRIVE study protocol: a randomized controlled trial evaluating a web-based app and tailored messages to improve adherence to adjuvant endocrine therapy among women with breast cancer. BMC Health Services Research 2019;19(1):977. - PMC - PubMed
Roberts 2019 {published data only}
    1. Roberts NA, Mudge A, Alexander K, Wyld D, Janda M. The iPROMOS protocol: a stepped-wedge study to implement routine patient-reported outcomes in a medical oncology outpatient setting. BMJ Open 2019;9(2):e027046. - PMC - PubMed
Rogers 2018 {published data only}
    1. Rogers S, Lowe D, Lowies C, Tien Yeo S, Allmark C, Mcavery D. Improving quality of life through routine use of the Patient Concerns Inventory (PCI) for head and neck cancer patients: a cluster preference randomized controlled trial. Psycho-oncology 2019;28(Suppl 2):10-1. - PMC - PubMed
    1. Rogers SN, Lowe D, Lowies C, Yeo ST, Allmark C, Mcavery D, et al. Improving quality of life through the routine use of the patient concerns inventory for head and neck cancer patients: a cluster preference randomized controlled trial. BMC Cancer 2018;18:444. - PMC - PubMed
Rogers 2019 {published data only}
    1. Rogers S, Lowe D, Lowies C, Tien Yeo S, Allmark C, Mcavery D, et al. Improving quality of life through routine use of the Patient Concerns Inventory (PCI) for head and neck cancer patients: a cluster preference randomized controlled trial. Psycho-oncology 2019;28(Suppl 2):10-1. - PMC - PubMed
    1. Rogers SN, Allmark C, Bekiroglu F, Edwards RT, Fabbroni G, Flavel R, et al. Improving quality of life through the routine use of the patient concerns inventory for head and neck cancer patients: baseline results in a cluster preference randomised controlled trial.. European Archives of Oto-Rhino-Laryngology. 2020;277:3435-47. - PMC - PubMed
    1. Rogers SN, Lowe D, Lowies C, Yeo ST, Allmark C, Mcavery D, et al. Improving quality of life through the routine use of the patient concerns inventory for head and neck cancer patients: a cluster preference randomized controlled trial. BMC Cancer 2018;18:444. - PMC - PubMed
Seppen 2020 {published data only}
    1. Seppen BF, L'ami MJ, Duarte Dos Santos Rico S, Ter Wee MM, Turkstra F, Roorda LD, et al. A smartphone app for self-monitoring of rheumatoid arthritis disease activity to assist patient-initiated care: protocol for a randomized controlled trial. JMIR Research Protocols 2020;9(2):e15105. [DOI: 10.2196/15105] - DOI - PMC - PubMed
Serrano‐Ripoll 2019 {published data only}
    1. Serrano-Ripoll MJ, Ripoll J, Valderas JM, Pastor-Moreno G, Labry Lima A, Ricci-Cabello I. Development and evaluation of an intervention based on the provision of patient feedback to improve patient safety in Spanish primary healthcare centres: study protocol. BMJ Open 2019;9(12):e031367. [DOI: 10.1136/bmjopen-2019-031367] - DOI - PMC - PubMed

Additional references

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