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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-30Ç‚

Once a month over 6 months

Ontological nurses

Yes

Yes

***

****

√√√

HADS

MOS-SS

GDS (short form)

QARSQ-PH

UMPSI

GSRE

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. Ç‚: 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.