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Table 3 The characteristics of design and study quality

From: A systematic review of the impact of routine collection of patient reported outcome measures on patients, providers and health organisations in an oncologic setting

Reference Country / Jurisdiction Design Sample / Population Outcome measures PROS used Intervention / Number of times feedback Members of medical team given feedback Management plan offered to team Training to staff Domain 1 Domain 2 Global Rating
Trowbridge et al. (1997) [39] USA (Central Indiana Community Cancer Centres, Indianapolis) RCT: Intervention / Control 320 cancer outpatients, 13 oncologists and 23 clinics Pain Management Index(ref); pain medication level (0–3) minus pain level: Patient assessment of pain, pain regiments and relief received Patterns of analgesic prescription Estimates of average and worst pain over the previous 7 days, satisfaction with current pain regimens and degree of relief received One Doctors only (12) No No ** *** √√
Tazenzer et al. (2000) [33] Canada (Tom Baker Cancer Centre , Calgary, Alberta) Before-after trial: usual care group /Intervention group with before as control 53 lung cancer patients attending an outpatient lung cancer clinic EORTIC QLQ-C30 11-item Patient Satisfaction Questionnaire (PDIS) ( adapted through Falvo and Smith,1983) Exit Interview (patient’s perception if QL issues had been addressed during the visit) Medical Record Audit on patients’ care plan EORTC QLQ-C30 (on a PC) Once Doctors and nurses No Ground round introduction and training * *** √√
McLachlan et al. (2001) [38] Australia (Peter MacCallum Cancer Centre, Melbourne) RCT: Intervention /control (ratio: 2:1) 450 cancer patients attending ambulatory clinics Patient HRQoL (EORTC QLQ-C30) 32-item Patient needs (Cancer Needs Questionnaire Short Form [CNQ] Patient distress (Beck Depression Inventory (BDI) Patient satisfaction (in 6-month) Services provided for those identified as required by coordination nurse EORTC QLQ-C30, CNQ, BDI (through a touch-screen PC) One Doctor and coordination nurse (numbers not reporter) Individualised plan developed by coordination nurse in accordance with generic psychosocial guidelines No ** *** √√
Detmar et al. (2002) [37] Netherland (Netherlands Cancer Institute, Amsterdam) RCT: (Cross-over design) Intervention/control 214 palliative cancer patients in a outpatient clinic of a cancer hospital Patient-doctor communication Doctor’s awareness of patient HRQoL Patient management Patients’/doctors’ satisfaction Patient HRQoL (SF-36) Patients’/doctors’ evaluation of intervention EORTC QLQ-30 Three Doctors (n=10) No Doctors given 30-mins training and patient mailed a leaflet *** **** √√√
Mooney et al. (2002) [16] USA (University of Utah, Salt Lake City, Utah) A pilot Prospective study over a month period with daily measures 27 patients receiving cancer chemotherapy at a cancer centre outpatient clinic Telephone-Linked Care system for Chemotherapy (TLC-Chemo Alert) Seven symptoms (nausea and vomiting, fatigue, trouble sleeping, sore mouth, fever, feeling blue, feeling anxious) Exit interview TLC-Chemo Alert Patients asked to report daily during the cycle and the alerts were sent to providers Doctors (n=2) Yes Patients trained (10 minutes TLC orientation) ** **
Velikova et al. (2004) [36] UK (Cancer Research UK Clinical Centre – Leeds) RCT: Intervention /control-attention/control in a ratio of 2:1:1 286 cancer outpatients attending a large cancer centre of a teaching hospital Patient HRQoL (FACT-G) Discussion of HRQoL issues in consultation Medical actions (decisions on cancer treatment, symptomatic/supportive treatment, investigations and referrals) Non-medical actions(advice on lifestyle, copying and reassurance) Physician checklist assessing the clinical usefulness of PROM data EORTC QOQ-C30 Hospital Anxiety and Depression Scale (HADS) Regular clinic visit over an average of 6 months Doctor (n=28) No One to one training and manual provided *** **** √√√
Basch et al. (2005) [41] USA (Memorial Sloan-Kettering Cancer Center, New York) Prospective pilot study of patient online self-reporting of toxicity symptoms 80 patients diagnosed with a gynaecologic malignancy starting a new chemotherapy regimen Pattern of use of a Self-reported online Symptom Track and Reporting (STAR) system Patient impression of such system based on an exit questionnaire survey Clinician feedback (through survey and team debriefing) Symptom Track and Reporting (STAR) based on NCI CATAE system Any clinic visits during 8-wk study period (mean=3, range 1–6) , also possible log in at home during the period Doctors and study team (n=unreported) Yes Training provide to patients but unreported to staff ** **
Boyes et al. (2006) [35] Australia (Centre for Health Research & Psycho-oncology, University of Newcastle) Pilot controlled trial: Intervention /control 80 cancer outpatients attending one cancer centre Patient symptoms Patient anxiety/depression(HADS) Patient needs (Supportive Care Needs Survey[SCNS] Acceptability of intervention to patient and doctors Symptoms, HADS SCNS 1st consultation – 100% patients: 2nd: 83%; 3rd: 71%; 4th: 60% Doctors (n=4) List of patients needs accompanied by suggestions for appropriate referral None ** *** √√
Hoeskstra et al. (2006) [42] Netherlands (Academic Medical Centre, University of Amsterdam) RCT: Intervention group with symptom monitoring / control 146 palliative cancer patients recruited through two hospitals and local GPs 10 symptoms from the Symptom Monitor Severity of the reported symptom (0–10 score) Symptom Monitor Extensive Questionnaire Weekly self-assessed Symptom Monitor at home; Extensive questionnaire every 2-month GPs (98 times) and medical specialists(96 times) No No ** *** √√
Korniblith et al. (2006) [43] USA (Dana-Farber Cancer Institute, Boston) RCT : Telephone Monitoring (TM) versus TM+Education Material (EM) 192 cancer patients with advanced disease and receiving active treatment EORTC-QLQ-30 HADS EORTC-QLQ-30ǂ Once a month over 6 months Ontological nurses Yes Yes *** **** √√√
GDS (short form)
Patient Satisfaction with the Research Program BOMC test;
Basch et al. (2007) [44] USA (Memorial Sloan-Kettering Cancer Center, New York) Prospective pilot study of a patient online self-reporting of toxicity symptoms 107 patients diagnosed with thoracic gynaecologic malignancy starting a new chemotherapy regimen Feasibility/Pattern of use of a Self-reported online Symptom Track and Reporting (STAR) system Patient satisfaction survey (an exit questionnaire survey) Nursing survey (through an exit survey) Symptom Track and Reporting (STAR) based on NCI CATAE system Any clinic visits during 42-wk study period (mean=12, range 1–40) , also possible log in at home during the period Nurses and study team (n=unreported) No Training provide to patients but unreported to staff ** **
Rosenbloom et al. (2007) [34] USA (Center on Outcomes, Research and Education, Evanston Northwestern Healthcare RCT: Structured interview and discussion / assessment control / standard care 213 patients with advanced breast, lung or colorectal cancer Patient HRQoL (Functioning Living Index – Cancer [FLIC]) Patient affect (Brief Profile of Mood States [Brief POMS]) Patient satisfaction [PSQ-III] Clinical treatment changes as reported by nurse (supportive care changes, referrals, ‘other’ clinical changes and changes in standard dose of chemotherapy as a result of PROs) FACT-G and a single item asking patients whether a particular symptom or problem was better than, worse than, or as expected Clinic visits at baseline ,and 1, 2,3 and 6 months Treating nurses (n=not reported) No No *** **** √√√
Weaver et al. (2007) [45] UK (Oxford Radcliffe Hospitals NHS Trust) A pilot study of novel mobile phone technology 6 colon cancer patients Questionnaire on symptoms derived from the Common Terminology Criteria for Adverse Events (CTCAE) grading system Questionnaire derived from the Common Terminology Criteria for Adverse Events (CTCAE) grading system Twice daily during the chemotherapy circle (one morning, one evening) Nurses (n= not reported) Yes Yes ** **
Butt et al.(2008) [46] USA (Center on Outcomes, Research and Education (CORE), Evanton Northwestern Healthcare) Prospective study to explore the longitudinal screening and management of fatigue, pain, and emotional distress 99 cancer patients with solid tumor of lymphoma undergoing cancer undergoing cancer treatment FACT-G FACT-Fatigue subscale Brief Pain Inventory (BPI) HADS Structured interview with patients on HRQL and symptom management FACT-G FACT-Fatigue subscale Brief Pain Inventory (BPI) HADS Baseline, 1 month and 2 months after the baseline Doctors and nurses ? ? ** **
Given et al. (2008) [47] USA( Michigan State University) RCT: Nurse-Administrated Symptom Management (NASM) vs Automated Telephone Symptom Management (ATSM) intervention 129 breast cancer patients Outcomes measured at 10–16 wks: 15 symptoms (0–10 scale) Responses & Non-responses of symptoms Time to response 15 symptoms (0–10 scale) Severity of the symptoms 6 contacts or self-reporting (1–4 wk, 6wk, 8wk) Nurses or ATSM system Yes Yes ** **** √√√
Hilarius et al. (2008) [48] Netherland (Hospital Pharmacy, Red Cross Hospital, Beverwijk) A sequential cohort design with repeated measures to evaluate the use of HRQL assessments in daily clinical oncology nursing practice 10 nurses and 219 patients cancer patients with either adjuvant or palliative chemotherapy in a community hospital Dartmouth Primary Care Cooperative Information Functional Health Assessment (COOPcharts) Patient Management extracted from medical record Patient satisfaction (an exit survey based on PSQ, Form II) Patients’ self-reported HRQL (SF-36, FACT-BCS, FACT-C, FACT-L) Nurse and patient evaluation of the intervention (an exit survey) EORTC QLQ-C30 EORTC QLQ-BR23 EORTC QLQ-CR38 EORTC QLQ-LC13 Four consecutive visits after baseline for both pre (control arm) and post (intervention arm) with a two-month ‘wash-out’ period Patients and nurses before consultations No Yes *** *** √√
Mark et al. (2008) [49] USA (Thomson Healthcare, Washington DC) A cross-sectional survey of the of both patients’ and health professionals’ experience; A before-after patient chart review 100 cancer patients and 92 health professionals on the experience of The Patient Assessment, Care and Education (PACE) System, including PCM instrument and an education component Questionnaire survey of 102 providers The patients satisfaction survey (n=100) including 8-item on PCM 200 patient chart reviews (100 charts before and 100 charts after the PACE system) PCM An education component (not reported in this study) Each visit to clinic Clinicians (n=unreported) No ? ** *** √√
Kearney et al. (2009) [50] UK (Cancer Care Research Centre, University of Stirling, Stirling) RCT: Control group versus intervention group (mobile phone-based remote monitoring of symptoms) over five time points 56 patients with lung, breast or colorectal cancer for each group (total 112 patients) Paper version of electronic, Mobile phone-based Advanced Symptom Management Systems (ASyMS©) based on Common Toxicity Criteria Adverse Events (CTCAE) grading system and the Chemotherapy Symptom Assessment Scale Mobile phone-based (ASyMS©) including chemotherapy-related morbidity of six common symptoms (nausea, vomiting, fatigue, mucositis, hand-foot syndrome and diarrhoea) Five times including baseline and each of four chemotherapy cycles over a period of 14 days Doctors only (n=unreported) Yes Yes ** **** √√
Carlson et al. (2010) [51] Canada (Tom Baker Cancer Centre, University of Calgary, Alberta) RCT: minimum screening (distress) / full screening / Triage : full screening + referring to appropriate services 585 breast cancer patients + 549 lung cancer patients Patient distress at 3-month follow-up; Depression and anxiety at 3-month follow-up Minimum screening: Distress thermometer (DT) Full screening: DT + Psychological scan for cancer part C (PSSCAN) Baseline Screening team member (n=unreported) Yes Yes **** **** √√√
Dinkel et al. (2010) [52] German (Department of Psychotherapy and Psychosomatic Medicine, Technische University Munchen) Paired comparison : a computerised and a paper version of Stress Index Radio Oncology (SIRO) tool Prospective survey 177 cancer patients in study 1, 273 cancer patients in study 2 (n=142 for computerised version and n=131 for paper version of SIRO) 27 Patients, urses/radiographs and 15 physicians evaluated the screening procedure Agreement between computer and paper version of SIRO Patient satisfaction; Time need for both modes; Perceived utility; Perceived impact on communication; Perceived impact on patient outcome SIRO Any visit Doctors and nurses (n=unreported) No No *** ** √√
Halkett et al. (2010) [11] Australian (WA Centre for Cancer and Palliative Care, Curtin University) Pilot study of using computer touch-screen technology to asses psychological distress in patients 60 patients with various gynaecological cancers Patient satisfaction with both touch-screen and paper questionnaire; Perceived utility of both modes by patients and health professionals EORTC QLQ-C30 HADS The Supportive Care Needs Scale The Distress Thermometer Follow questionnaire survey on perceived utility of both modes Once Nurses and doctors Yes Yes * **
Ruland et al. (2011) [53] Norway (Centre for Shared Decision Making and Nursing Research, Oslo University Hospital, Oslo) RCT: a computer-assisted, interactive tailored assessment (ITPA) with feedback vs ITPA only in oncology practice 145 patients treated for leukaemia or lymphoma Number of patient symptoms and problems addressed Changes in symptom distress Changes in patients’ need for symptom management support over time, SF-36, Center for Epidemiological Studies Depression Scale (CES-D), Medical Outcome Study Social Support Scale (MOS – SS) Choice ITPA(19 symptoms (0–4 scale on bothersome) and a severity scale of 0–10) Every inpatient admission with up to four follow-up visits Doctors and nurses (n=unreported) No (as see appropriate) Yes *** **** √√√
Velikova et al. (2010) [54] UK (Cancer Research UK Clinical Centre – Leeds) RCT: Intervention/control-attention/control in a ratio of 2:1:1 286 cancer patients commencing treatment at the Medical Oncology Clinic at St James Hospital Medical Care Questionnaire (MCQ): 15-item three subscales: Communication, Coordination, Patient preferences Satisfaction with care Patients’ and physicians’ evaluation of the intervention K-index (Continuity of care: K=(number of visits – number of doctors)/(number of visits −1). EORTC QOQ-C30 Hospital Anxiety and Depression Scale (HADS) Regular clinic visit over an average of 6 months Doctor (n=28) No One to one training and manual provided *** **** √√√
Bainbridge et al.(2011) [55] Canada (Juravinski Cancer Centre, McMaster University, Hamilton, Ontario) Survey on the utility of 128 nurses, physicians, and allied health professionals Perceptions of use and utility of the Edmonton Symptom Assessment System (ESAS) adopted by Ontario’s cancer centres since 2007 ESAS Every clinic visit Doctors and nurses Yes Yes * *
Berry et al. (2011) [56] USA (Dana-Faber Cancer Institute, Boston) RCT: Intervention / Control 660 cancer patients with various cancer diagnoses and stages at two institutions of a comprehensive cancer centre 1.Audio-recorded content of all communication between clinicians, patients and accompanying friends or family members at each T2 visit (4–6 wks after the treatment) Patient reported symptoms and quality-of-life (SQLIs) from the Electronic Self-Report Assessment-Cancer (ESRA-C) Every clinic visit during the study period Doctors (n=76 principle physicians and other) or incorporated into charts (n=unreported) No Yes *** **** √√√
2.Clinic visit duration
3. Physician exit questionnaire survey
Cleeland et al. (2011) [20] USA (MD Anderson Cancer Center, The University of Texas) RCT: e-mail alert of symptom to patients’ clinical team versus no e-mail alert 79 lung cancer patients receiving thoracotomy 1. Four targeted symptom: pain, distress, disturbed sleep, and shortness of breath, constipation (no fatigue as no effective response) 2. MD Anderson Symptom Inventory (MDASI) at follow-up clinic visit 3. An exit questionnaire survey Automated telephone calls (IVR system): MDASI (13 common cancer related symptoms) Twice weekly, up to 4 wks after discharge Nurses (n=unreported) Yes Training to patients provided ** **** √√
Takeuchi et al. (2011) [57] UK (St James’s Institute of Oncology, Leeds) Longitudinal study of data as part of Velikova et al. (2004, 2010) RCT 286 cancer patients commencing treatment at the Medical Oncology Clinic at St James Hospital Audio-recorded content of Patient-physician communication: Longitudinal impact of PRO intervention; dynamics of communication; association between severity of symptoms/functions and clinic discussion EORTC QOQ-C30 Hospital Anxiety and Depression Scale (HADS) Four consecutive visits from baseline Doctor (n=28) No One to one training and manual provided *** **** √√√
  1. *: Four stars indicate a randomised trial or experimental study; 3 stars indicate a controlled trial, pre–post trial with control (controlled before–after trial), time series, or observational cohort with multivariable adjustment; 2 stars indicate a pre–post trial without control, observational cohort study without multivariable adjustment, cross-sectional study without multivariable adjustment, analysis of time trends without control, or well-designed qualitative study; and 1 star indicates a case series, other qualitative study, or survey (descriptive) study.
  2. √: Three checks indicate great weight in the stratum’s body of evidence, 2 checks indicate moderate weight, and 1 check indicates little weight.
  3. ǂ: EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life (EORTC QLQ) Core Questionnaire; SF-36: The Short Form(36) Health Survey; FACT-G: Functional Assessment of Cancer Therapy-general; EORTC QLQ-BR23: EORTC QLQ Breast Cancer Scale; EORTC QLQ-CR38: EORTC QLQ Colorectal Cancer Scale; EORTC QLQ-LC; EORTC QLQ Lung Cancer Scale; NCI CATAE: National Cancer Institute Common Terminology Criteria for Adverse Events; FACT-BCS: Functional Assessment for Cancer Therapy-Breast Cancer Subscale; FACT-C: Functional Assessment of Cancer Therapy-Colorectal Quality of Life Instrument; FACT-L: Functional Assessment of Cancer Therapy-Lung Cancer Subscale; MOS-SS: Medical Outcomes Study Social Support Survey; GDS: Geriatric Depression Scale (short form); QARSQ-PH: Physical Health subscale of the Older American Resources and Services Questionnaire (OARSQ); UMPSI: Utilisation of Mental Health and Psychosocial Services Instrument; GSRE: Geriatric Schedule of Recent Experience Instrument;
  4. ?: No data or unable to classify data available.