Patient Preference Questionnaire Research Articles

Patients' preference of trastuzumab administration (subcutaneous versus intravenous) in HER2-positive metastatic breast cancer: Results of the randomised MetaspHer study

HannaH (NCT00950300) and PrefHer (NCT01401166) studies validated the subcutaneous (H-s.c.) formulation of trastuzumab as effective and safe as intravenous (H-i.v.) and highly preferred by patients in early breast cancer. The present randomised MetaspHer trial (NCT01810393) is the first study assessing patient's preference in metastatic setting. MethodsPatients with HER2-positive metastatic breast cancer who completed a first line chemotherapy with trastuzumab and achieved a long-term response lasting more than 3 years were randomised to receive 3 cycles of 600-mg fixed-dose adjuvant H-s.c., followed by 3 cycles of standard H-i.v., or the reverse sequence. Primary end-point was overall preference for H-s.c. or H-i.v. at cycle six, assessed by Patient Preference Questionnaire (PPQ). Secondary end-points included healthcare professional (HCP) satisfaction; safety and tolerability; quality of life. ResultsHundred and thirteen patients were randomised and treated. H-s.c. was preferred by 79/92 evaluable intent-to-treat patients (85.9%, 95% confidence interval [CI; 78.8–93.0]; p < 0.001), 13/92 preferred H-i.v. (14.1%, 95% CI [7.0–21.3]). HCPs were most satisfied with H-s.c. (56/88 available data, 63.6%, [53.6–73.7]). On the safety population, adverse events occurred in 73 (67.6%) and 49 (44.1%) patients during the H-s.c. and H-i.v. periods, respectively; 7 (6.5%) and 4 (3.6%) were grade ≥ III, 3 (2.8%) and 2 (1.8%) were serious. ConclusionThe safety was consistent with the known H-i.v. and H-s.c. profiles without safety concern raised. Definitively, patients preferred H-s.c. as reported in early stage by PrefHer study.

Preference for subcutaneous or intravenous administration of rituximab among patients with untreated CD20+ diffuse large B-cell lymphoma or follicular lymphoma: results from a prospective, randomized, open-label, crossover study (PrefMab)

The aim of this study was to evaluate patient preference and satisfaction for the subcutaneous (s.c.) versus intravenous (i.v.) formulation of rituximab given with chemotherapy in previously untreated patients with CD20+ diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL). Patients received eight cycles of rituximab according to 2 schedules: Arm A received 1 cycle rituximab i.v. (375 mg/m2) and 3 cycles rituximab s.c. (1400 mg) then 4 cycles rituximab i.v.; Arm B received 4 cycles rituximab i.v. (375 mg/m2) then 4 cycles rituximab s.c. (1400 mg). Alongside rituximab, both arms received 6-8 cycles of chemotherapy (cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP), cyclophosphamide, vincristine, prednisone (CVP), or bendamustine as per standard local practice). Preference for s.c. or i.v. administration was evaluated using the Patient Preference Questionnaire (PPQ) at cycles 6 and 8. Patient satisfaction and convenience were assessed using the Cancer Therapy Satisfaction Questionnaire (CTSQ), and Rituximab Administration Satisfaction Questionnaire (RASQ) at cycles 4 and 8. At the primary data cut-off (19 January 2015), the intent-to-treat population comprised 743 patients. The majority had DLBCL (63%) and baseline characteristics were balanced between arms. At cycle 8, 81% of patients completing the PPQ preferred rituximab s.c. Preference was not impacted by treatment sequence or disease type. Patient satisfaction as measured by RASQ was higher for s.c. versus i.v. CTSQ scores were similar between arms. Adverse events were generally balanced between administration routes and no new safety signals were detected. Most previously untreated patients with CD20+ DLBCL or FL preferred s.c. to i.v. rituximab administration. Patient satisfaction with rituximab treatment was generally greater with s.c. administration. NCT01724021 (ClinicalTrials.gov).

HPV Testing of Self-Collected Vaginal Swabs for Cervical Cancer Prevention in South Africa

Abstract 33 Background: Cervical cancer screening programs in Low and Middle Income Countries (LMIC) need to be strengthened. One of the challenges is insufficient health care personnel to achieve optimal coverage. We evaluated the potential of human papillomavirus (HPV) testing using self-collected vaginal swabs to improve screening. Methods: As part of a larger NCI-supported study in Cape Town, South Africa, we recruited 261 HIV-uninfected and 237 HIV-infected women aged 30-60 years, at one primary health care site. All women were instructed to self-collect a vaginal swab on site immediately prior to a gynecologic exam, during which a cervical sample was collected. Both self- and clinician-collected samples were tested for high risk HPV types (16, 18, 45, 31, 33, 35, 52, 58, 51, 59, 39, 56, 66, 68) using Cepheid GeneXpert (HPV XpertTM). All women underwent at least one colposcopy with histological sampling. Classification of endpoint was based on expert pathology review. Results: The HPV prevalence using the cervical vs. self sample, respectively, was 14% vs. 25% among HIV-uninfected and 50% vs. 62% among HIV-infected women. Among women who were diagnosed with grade 2 or 3 cervical intraepithelial neoplasia (CIN) or cervical cancer, 94% were positive on HPV Xpert on the cervical and 88% on the vaginal swab, ignoring HIV status. However, specificity was poor for HPV tests done on self samples, 78% in HIV-uninfected and 52% in HIV-infected women. On a patient preference questionnaire, &gt;90% of women stated they would be prepared to collect a sample at home and two-thirds expressed a preference to be examined by a clinician. Conclusion: Even in self-collected vaginal samples, HPV Xpert has excellent sensitivity for detecting cervical cancer precursor lesions. In LMIC settings where the ratio of health care workers to the population is low, HPV testing of self-collected samples could successfully triage women who require further evaluation and treatment. AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST: Louise Kuhn No relationship to disclose Rakiya Saidu No relationship to disclose Cecilia Svanholm-Barrie No relationship to disclose Ana Tergas Consulting or Advisory Role: Helomics Rosalind Boa No relationship to disclose Jennifer Moodley No relationship to disclose Thomas C. Wright No relationship to disclose David Persing No relationship to disclose Scott Campbell No relationship to disclose Lynette Denny No relationship to disclose

Use of a patient completed iPad questionnaire to improve pre-operative assessment.

Developments in healthcare technology could improve patient care and reduce healthcare costs. There is a need to facilitate communication and increase efficiency in surgical pre-assessment clinics. This study aimed to develop an iPad application to deliver an electronic patient questionnaire, and to evaluate its use in the pre-assessment environment. Software was developed, MyOp, for a standard iPad that mirrored the paper-based pre-assessment system, with features designed for ease of patient use and remote data transfer. A case-control study was conducted, comparing use of MyOp with paper-based practice, to evaluate feasibility and patient preference. Patients were offered the use of MyOp or paper-based system. Outcomes measured included time to complete iPad questionnaire, consultation duration, and a patient preference questionnaire. MyOp cost £3500 to develop. 104 individuals participated in the study, 53 MyOp and 51 controls. MyOp reduced the median consultation duration by 5.00min. A reduction was seen in all subgroups except those aged over 70 or urology patients. Patients preferred to complete the form independently, using a touchpad or computer but expressed concerns about data security. Use of an electronic patient questionnaire reduces consultation time delivering greater efficiency of pre-assessment nurse time. Preconceived ideas about the use of technology in older age groups are likely inaccurate and less of a barrier than previously thought. Electronic pre-assessments could be used routinely to reduce demands on healthcare facilities, improve patient care, and triage patients prior to clinic attendance.

Prefmab: Final Analysis of Patient Preference for Subcutaneous Versus Intravenous Rituximab in Previously Untreated CD20+ Diffuse Large B-Cell Lymphoma and Follicular Lymphoma

BackgroundRituximab in combination with chemotherapy is the standard of care for patients with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). To improve patient convenience and to reduce healthcare resource burden, a subcutaneous (SC) formulation of rituximab has been developed and has been shown to be clinically comparable to intravenous (IV) rituximab. The aim of this study was to evaluate patient preference for rituximab IV or SC administration.MethodsPrefmab (NCT01724021) is a randomized, open-label, crossover phase IIIb study. Eligible patients were aged ≥18 to ≤80 years with previously untreated CD20+ DLBCL (IPI 1-4 or 0 with bulky disease) or FL (FLIPI grade 1-3a), at least 1 bidimensionally measureable lesion ≥1.5cm at its largest dimension by computed tomography, and an ECOG performance status ≤3; all provided written informed consent. Patients received 8 cycles of rituximab according to 2 schedules: Arm A received 1 cycle of rituximab IV (375mg/m2) and 3 cycles of rituximab SC (1400mg) then 4 cycles of rituximab IV; Arm B received 4 cycles of rituximab IV (375mg/m2) then 4 cycles of rituximab SC (1400mg). Alongside rituximab, both arms received 6-8 cycles of chemotherapy (CHOP [cyclophosphamide, doxorubicin, oncovin, prednisone], CVP [cyclophosphamide, vincristine, prednisone], or bendamustine as per standard local practice). A Patient Preference Questionnaire (PPQ) was conducted post-rituximab therapy at cycles 6 and 8. The primary endpoint was overall preference for rituximab IV or SC. The strength of patient preference was also assessed (very strong, fairly strong, or not very strong). Adverse events (AEs), including administration-related reactions, were evaluated according to NCI-CTCAE version 4.0.ResultsAt the primary data cut-off (January 19, 2015), the intent-to-treat population comprised 743 patients (Arm A: n=372; Arm B: n=371). The majority of patients had DLBCL (63%). The median age was 60 years (range 18-80) and baseline characteristics were balanced between arms. One hundred and twenty patients discontinued immunochemotherapy treatment prematurely, primarily due to AEs (n=52), but entered follow-up. A further 108 patients (Arm A: n=48; Arm B: n=60) discontinued the study and did not complete follow-up, primarily due to death (53 patients [DLBCL: n=48; FL: n=5], 19 of whom died due to progressive disease [DLBCL: n=16; FL: n=3]), patient request/withdrawal of consent (n=23), or AEs (n=9). Rates of study discontinuation and treatment discontinuation were balanced between arms. The PPQ was completed by 620 patients at cycle 6 and 591 at cycle 8. At cycle 6, rituximab SC was preferred by 80% (n=495) of patients (Arm A: 79%; Arm B: 81%) and rituximab IV by 10% (n=62; Arm A: 11%; Arm B: 9%), while 10% (n=63) had no preference (Arm A: 10%; Arm B: 10%). At cycle 8, the respective values were 81% (n=477; Arm A: 77%; Arm B: 84%), 11% (n=66; Arm A: 13%; Arm B: 10%), and 8% (n=48; Arm A: 10%; Arm B: 6%). The strength of patient preference for rituximab SC or IV is shown in Figure 1. Of patients who preferred rituximab SC, the main reasons were 'less time in the clinic' (cycle 6: 68%; cycle 8: 69%) and 'feels more comfortable during administration' (cycle 6: 37%; cycle 8: 37%). The mean cumulative rituximab administration time (mean ± standard deviation) was 865 ± 401 min for rituximab IV compared with 37 ± 100 min for rituximab SC. AEs were generally balanced between rituximab IV and SC administration, with the exception of gastrointestinal disorders (IV: 55%; SC: 31%) in patients with FL, notably nausea (IV: 28%; SC: 11%), constipation (IV: 14%; SC: 6%), and vomiting (IV 12%; SC 2%). No new safety signals were detected.ConclusionsMost previously untreated patients with CD20+ DLBCL or FL preferred SC compared with IV administration of rituximab, mainly due to reduction in the duration and discomfort of administration. [Display omitted] DisclosuresRummel:Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Plenteda:Roche: Other: Sub-investigator. Mendoza:Roche: Employment. Smith:Roche: Employment. Osborne:Roche: Employment. Grigg:Merck: Honoraria, Membership on an entity's Board of Directors or advisory committees; Gilead: Honoraria, Membership on an entity's Board of Directors or advisory committees; Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees; BMS: Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees.

Preference, satisfaction and critical errors with Genuair and Breezhaler inhalers in patients with COPD: a randomised, cross-over, multicentre study.

Background:The specific attributes of inhaler devices can influence patient use, satisfaction and treatment compliance, and may ultimately impact on clinical outcomes in patients with chronic obstructive pulmonary disease (COPD).Aims:To assess patient preference, satisfaction and critical inhaler technique errors with Genuair (a multidose inhaler) and Breezhaler (a single-dose inhaler) after 2 weeks of daily use.Methods:Patients with COPD and moderate to severe airflow obstruction were randomised in a cross-over, open-label, multicentre study to consecutive once-daily inhalations of placebo via Genuair and Breezhaler, in addition to current COPD medication. The primary end point was the proportion of patients who preferred Genuair versus Breezhaler after 2 weeks (Patient Satisfaction and Preference Questionnaire). Other end points included overall satisfaction and correct use of the inhalers after 2 weeks, and willingness to continue with each device.Results:Of the 128 patients enrolled, 127 were included in the safety population (male n=91; mean age 67.6 years). Of the 110 of the 123 patients in the intent-to-treat population who indicated an inhaler preference, statistically significantly more patients preferred Genuair than Breezhaler (72.7 vs. 27.3%; P<0.001). Mean overall satisfaction scores were also greater for Genuair than for Breezhaler (5.9 vs. 5.3, respectively; P<0.001). After 2 weeks, there was no statistically significant difference in the number of patients who made ⩾1 critical inhaler technique error with Breezhaler than with Genuair (7.3 vs. 3.3%, respectively).Conclusions:Patient overall preference and satisfaction was significantly higher with Genuair compared with Breezhaler. The proportion of patients making critical inhaler technique errors was low with Genuair and Breezhaler.

Safety, feasibility, and efficacy of placement of steroid-eluting bioabsorbable sinus implants in the office setting: a prospective case series.

The outcomes of endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) can be compromised by postoperative inflammation, recurrent polyposis, middle turbinate lateralization, and synechiae, often requiring subsequent interventions.A bioabsorbable steroid-eluting sinus implant placed in the operating room following ESS has been proven safe and effective in 2 randomized controlled trials and a subsequent meta-analysis, for its ability to preserve sinus patency, and reduce medical and surgical interventions. This trial sought to evaluate the safety, feasibility, and outcomes of implants placed in the office after achieving hemostasis. Twenty patients with CRS underwent ESS including bilateral ethmoidectomy.A steroid-eluting bioabsorbable implant was deployed into each ethmoid cavity in the office within 7 days after ESS. Endoscopic appearance of the ethmoid cavities was evaluated at 1 week, 2 weeks, and 4 weeks postoperatively by the operating surgeon and an independent blinded evaluator. Procedural tolerance was assessed at week 2 using a patient preference questionnaire. The 20-item Sino-Nasal Outcome Test (SNOT-20) questionnaire was completed at baseline, week 2, and week 4. In-office placement of steroid-eluting bioabsorbable implants was well tolerated, with 90% of patients very satisfied with the overall experience, and 80% very satisfied with the recovery process. At 1 month, there were no significant adhesions or frank polyposis, and middle turbinate lateralization was only 5%. Compared to baseline, ethmoid sinus inflammation was significantly reduced (p = 0.03), and the mean SNOT-20 score was significantly improved (p < 0.001). In-office placement of steroid-eluting bioabsorbable implants after achieving hemostasis was well tolerated and might improve local drug diffusion and surgical outcomes.

Assessing adherence factors in patients under topical treatment: development of the Topical Therapy Adherence Questionnaire (TTAQ)

Medication adherence rates strongly depend on favorable disease outcomes. It is known that medication adherence rates are lower for topical treatment than for systemic treatment. However, to date no validated instrument for the assessment of adherence factors in topical treatment is available. The aim of this study was to develop a new questionnaire to assess adherence risk factors in topical treatment. The development of the Topical Therapy Adherence Questionnaire (TTAQ) and Patient Preference Questionnaire (PPQ) was based on a systematic literature review, and qualitative patient focus interviews and expert focus groups’ input. The psychometric properties and comprehensibility of the TTAQ and PPQ were assessed in a feasibility study with 59 psoriasis patients. Our first preliminary results indicate that the TTAQ and PPQ are psychometrically sound and reliable measures for the assessment of factors influencing topical treatment adherence. The questionnaires are currently being further developed and various parameters (e.g., time point of assessment) are currently being tested in an exploratory pilot study with ca. 2,000 psoriasis patients receiving topical treatment in a European clinical trial. The use of the final versions of TTAQ and PPQ in clinical practice may facilitate the early identification of specific non-adherence factors in patients under topical treatment, which could enable designing and applying adherence-enhancing interventions according to the patient’s individual needs.Electronic supplementary materialThe online version of this article (doi:10.1007/s00403-014-1446-x) contains supplementary material, which is available to authorized users.

Health-related quality of life and functional ability in patients with early arthritis during remission steered treatment: results of the IMPROVED study

IntroductionThe aim of this study was to investigate patient reported outcomes (PROs) of functional ability and health related quality of life (HRQoL) in patients with early (rheumatoid) arthritis during one year of remission steered treatment.MethodsIn this study, 610 patients with early rheumatoid arthritis (RA) or undifferentiated arthritis (UA) were treated with methotrexate (MTX) and tapered high dose of prednisone. Patients in early remission (Disease Activity Score (DAS) <1.6 after 4 months) tapered prednisone to zero and when in persistent remission, also tapered MTX. Patients not in early remission were randomized to either MTX + hydroxychloroquine + sulphasalazine + prednisone (arm 1) or to MTX + adalimumab (arm 2). Every 4 months, patients filled out the Health Assessment Questionnaire (HAQ) and the McMaster Toronto Arthritis Patient Preference Questionnaire (MACTAR), the Short Form 36 (SF-36) and visual analogue scales (VAS). Change scores were compared between treatment groups. The association with achieving remission was analyzed using linear mixed models.ResultsDuring year 1, patients who achieved early remission had the most improvement in PROs with scores comparable to the general population. Patients in the randomization arms showed less improvement. Scores were comparable between the arms. There was a significant association between achieving remission and scores of HAQ, MACTAR and physical HRQoL.ConclusionsIn early arthritis, PROs of functional ability and HRQoL after one year of remission steered treatment reach normal values in patients who achieved early remission. In patients not in early remission, who were randomized to two strategy arms, PROs improved less, with similar scores in both treatment arms.Trial registrationsISRCTN11916566 and EudraCT2006-006186-16

792PD - Quality of Life (QOL) among Renal Cell Carcinoma (RCC) Patients in A Randomized Double Blind Cross-Over Patient Preference Study of Pazopanib (P) Versus Sunitinib (S)

ABSTRACT Introduction PISCES was a randomized, double blind, cross-over study of P versus S in 168 patients with metastatic RCC. P and S are oral tyrosine kinase inhibitors with demonstrated clinical efficacy in RCC, but different side effect profiles. After exposure to both treatments, P was preferred over S by a 3:1 margin (70% vs. 22%) among the 114 patients who completed the patient preference questionnaire. Methods Patients received either P for 10 weeks, followed by a 2-week washout period, and then 10 weeks of S, or S for 10 weeks, followed by a 2-week washout period, and then 10 weeks of P. The primary endpoint was patient treatment preference. Secondary endpoints included reason for preference and QoL, as assessed by the Functional Assessment of Cancer Therapy-Fatigue (FACIT-F), the EQ-5D, and a Supplementary Quality of Life Questionnaire (SQLQ), which assessed worst soreness in the mouth/throat, hands, and feet and limitations due to soreness. The SQLQ and the FACIT-F were administered at baseline and every two weeks thereafter. The EQ-5D was administered at baseline, the end of the washout period, and the end of period 2. Change from period baseline to period average score were compared across treatments. Crossover analyses compared patients' average scores on each treatment, adjusting for sequence. Results The FACIT-F crossover analyses favored P over S by 2.5 points (p = .002). SQLQ crossover analyses favored P over S on worst soreness in the hands, feet and mouth/throat (p Conclusion Patient-reported QoL crossover results favor P over S on fatigue, foot soreness, hand soreness and mouth/throat soreness. These results are consistent with patient preference for P over S, and should be considered in light of their comparative efficacy. Disclosure D. Cella: Dr. Cella has consulted to GSK and has received research grant support from GSK. K. Kaiser: Dr. Kaiser has received research grant support from GSK. J. Beaumont: Ms. Beaumont has received research grant support from GSK. J. Diaz: Dr. Jose Diaz is a GSK employee and stock owner. L. McCann: Dr. McCann is a GSK employee and stock owner. F. Mehmud: Dr. Mehmud is a GSK employee and stock owner. S. Lata: Dr. Lata is a GSK employee and stock owner. P. Bono: Dr. Bono has received honorarium from GSK and Pfizer. C. Porta: Dr. Porta has acted as consultant or speaker for GSK, Bayer-Schering, Pfizer, Novartis, Roche, Aveo, Astellas, Boehringer Ingellheim and Recordat and received research funding from Novartis and Bayer-Schering. B. Escudier: Dr. Escudier has received honorarium from GSK, Pfizer, Novartis, Bayer, Aveo, and BMS.

Validity and Responsiveness of the Dutch McMaster Toronto Arthritis Patient Preference Questionnaire (MACTAR) in Patients with Osteoarthritis of the Hip or Knee

To determine the content validity, the construct validity, and the responsiveness of the Dutch McMaster Toronto Arthritis Patient Preference Questionnaire (MACTAR) in patients with osteoarthritis (OA) of the hip or knee. The MACTAR comprises 2 parts: a transitional part and a status part. Content validity was investigated by comparing patient-elicited activities to items on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Medical Outcomes Study Short-Form 36 (SF-36). Construct validity was determined by correlating MACTAR outcomes with WOMAC/SF-36 outcomes. Responsiveness was investigated by correlating MACTAR, WOMAC, and SF-36 change scores with patient global assessment (PGA) scores and plotting a receiver-operating characteristics (ROC) curve. Eleven percent of the 894 impaired activities, identified by 192 patients, were not represented in either the WOMAC or the SF-36. The correlations (r(s)) investigated for the MACTAR transitional part varied between 0.27 and -0.40; the status part correlated moderately with the general health scale of the SF-36 (r(s) = 0.44). MACTAR change scores correlated better with PGA than with WOMAC/SF-36 change scores. The area under the ROC curve amounted to 0.90. Our results suggest that the MACTAR exhibits moderate construct validity and good responsiveness in a population of patients with OA of the hip or knee. The MACTAR is potentially better able to detect changes over time in activities that are important to individual patients compared to other tools measuring physical function (WOMAC, SF-36). Clinicians could use the MACTAR to evaluate clinically relevant changes over time in patient-specific physical functioning.

Arthroscopic surgery provides no additional benefit over physiotherapy and medication for the treatment of knee osteoarthritis

What is the effect of the addition of arthroscopy to physiotherapy and medication in patients with osteoarthritis (OA) of the knee? Randomised, controlled trial with blinded outcome assessment and intention-to-treat analysis. A university sports medicine clinic in Ontario, Canada. Adults with idiopathic or secondary moderate-to-severe oa of the knee (Grade 2, 3, or 4 radiographic severity on the modified Kellgren-Lawrence classification). Key exclusion criteria were large meniscal tears, inflammatory arthritis, previous arthroscopic treatment for knee OA and more than 5 degrees of lateral deformity. Randomisation of 188 participants allotted 94 to an intervention group and 94 to a control group. The intervention group underwent arthroscopy within 6 weeks after randomisation and a standard physiotherapy and medication regimen was initiated within 7 days after surgery. the control group initiated the same physiotherapy and medication regimen at an equivalent time. Physiotherapy was provided for 1 hour once a week for 12 weeks. It included range-of-motion and strengthening exercises to be performed at home twice daily, information about activities of daily living, instruction in the use of heat and cold, and an educational video. Exercises were individualised according to the severity of oa and age. After the 12-week period, participants were advised to continue the exercise program. medications (potentially including paracetamol, non-steroidal anti-inflammatory drugs, hyaluronic acid, and glucosamine) were prescribed according to standard guidelines. The primary outcome was the WOMAC score at 2 years follow up. The WOMAC is scored from 0 (worst) to 2400, with subscales for pain, stiffness, and physical function. Secondary outcomes included the Physical Component Summary Score of the Short Form-36 (0 to 100); the McMaster Toronto Arthritis patient preference (MACTAR) questionnaire (0 to 500); and the Arthritis Self-Efficacy Scale (ASES) (10 to 100). 168 participants completed the study. After 2 years, the mean (SD) WOMAC scores were 874 (624) in the intervention group and 897 (583) in the control group, mean difference 23 (95% CI -208 to 161). The groups differed on the SF-36 by only 0.2 (95% CI -3.2 to 3.6), on the MACTAR questionnaire by only 6 (95% CI -37 to 49), and on each of the ASES subscales by less than 6 (all non-significant). The addition of arthroscopy to a regimen of physiotherapy and medication does not improve physical function, pain, or health-related quality of life in patients with moderate-to-severe OA of the knee.

Primary care sector versus treatment centre follow up for post-treatment cervical squamous intraepithelial neoplasia (SIL)

The NHSCSP 2004 guideline recommends that the best practice for the follow up of post-treatment squamous intraepithelial neoplasia (SIL) is by cytological surveillance in the treatment centre or alternatively, in the primary care sector as a minimum standard. We undertook this study to test this recommendation. In a colposcopy clinic of a district general hospital of UK. Retrospective analysis of 418 patients treated for squamous intraepithelial neoplasia whose post treatment cytological surveillance was followed up for 18 months after treatment. A prospective patient preference questionnaire was also undertaken in 50 randomly chosen patients having treatment to elicit their preferences for the place of follow up. At 8 months 66.4% had their first smear in the primary care sector as compared to 88.6% in the treatment centre. The post-treatment follow up smear performance graph seems to be different for the primary care sector compared to treatment centre. In 12 months nearly 90% of the patients had at least one smear and by 18 months 96.9% of the treated patients had a follow up smear in the community which would detect residual disease. There was no statistically significant difference in the detection of residual disease in the community compared to the treatment centre during the follow up period. A total of 76% of patients preferred to have their follow up smears in the primary care. Targets set by the NHSCSP of UK were not met either by the primary care sector or the treatment centre in the 8 months but was satisfactorily achieved by both in 12 months. These preliminary results indicate a need for a larger multi centre randomised trial to establish if the primary sector is truly a satisfactory alternative for patient follow up. Cytological surveillance is best carried out in the place desired by the patients to allow good compliance with the monitoring process.

Multicentre intraindividual randomized trial of topical methyl aminolaevulinate–photodynamic therapy vs. cryotherapy for multiple actinic keratoses on the extremities

Methyl aminolaevulinate-photodynamic therapy (MAL-PDT) is an effective treatment in facial/scalp actinic keratosis (AK). The aims of this study were to compare efficacy, safety, cosmetic outcome and patient preference of MAL-PDT vs. cryotherapy in patients with AK at other locations. A multicentre, controlled, randomized, open, intraindividual, right-left comparison was performed. Patients with nonhyperkeratotic AK were treated once with MAL-PDT and cryotherapy on either side of the body. At week 12, lesions showing noncomplete response were retreated. The primary efficacy variable was the lesion response at week 24. Investigator's assessment of cosmetic outcome, patient's preference in terms of cosmetic outcome and a patient preference questionnaire were also analysed at week 24. In total, of 121 patients with 1343 lesions (98% located on the extremities and the remainder on the trunk and neck) were included. Both treatments provided a high mean percentage reduction in lesion count at week 24 with significantly higher efficacy for cryotherapy: 78% for MAL-PDT and 88% for cryotherapy (P=0.002, per protocol population). Investigator's assessment of cosmetic outcome was significantly better for MAL-PDT than cryotherapy (P<0.001), 79% of lesions having an excellent cosmetic outcome with MAL-PDT vs. 56% with cryotherapy at week 24. The cosmetic outcome achieved by MAL-PDT compared with cryotherapy was also preferred by patients (50% vs. 22%, respectively, P<0.001), and 59% of patients would prefer to have any new lesions treated with MAL-PDT compared with 25% with cryotherapy (P<0.001). Both treatment regimens were safe and well tolerated. MAL-PDT showed inferior efficacy for treatment of non-face/scalp AK compared with cryotherapy. However, both treatments showed high efficacy, and MAL-PDT conveyed the advantages of better cosmesis and higher patient preference.

Development of questionnaires to measure patient preferences for intranasal corticosteroids in patients with allergic rhinitis

To develop a questionnaire to evaluate preferences for attributes of intranasal corticosteroids (INSs) in clinical trials with allergic rhinitis (AR) patients. Established questionnaire development practices were used, including performance of a literature review and use of patient and physician focus groups, cognitive debriefing interviews, and pilot testing before validation. Findings from patient and physician focus groups suggest that sensory attributes are relevant to AR patients when choosing INSs. Physician focus groups identified the need for 2 distinct preference instruments, a clinical trial patient preference questionnaire (CTPPQ) and a clinical practice preference questionnaire (CPPPQ). A pilot study suggests that the CTPPQ is capable of discriminating between 2 INSs in the clinical trial setting. Initial findings suggest that items in the CTPPQ and CPPPQ are easy to understand and relevant to patients. Further validation studies with larger sample sizes are needed to assess the psychometric properties of both questionnaires. B-20.

Home care versus hospital care in patients with multiple myeloma treated with pamidronate

Long-term bisphosphonate therapy has been shown to offer clinical benefit in the management of multiple myeloma. This study sought to explore the feasibility and potential advantages of monthly home-based intravenous infusions of pamidronate in patients with multiple myeloma. In a prospective crossover, multicentre trial, 37 patients were randomly allocated to receive 3 months of treatment with pamidronate given in the home followed by 3 months of treatment with pamidronate given in hospital or vice versa. Results from a patient preference questionnaire indicated most patients preferred treatment at home. Quality-of-life measurement was undertaken using the EORTC QLQ-C30 questionnaire. The results indicated a small, generally consistent, although not statistically significant, trend in favour of home care treatment. Extra nursing specialist time was required for home therapy. Home therapy with pamidronate in patients with multiple myeloma appeared feasible and safe and was preferred by patients in this study.

Are patients' decision-making preferences being met?

To investigate the information and decision-making expectations of general practice patients during real life consultations. Post-consultation, quantitative patient preference and enablement questionnaire. Patients attending for routine appointments in general practice surgeries in Oxfordshire, UK. Thirteen Oxfordshire general practitioners (GPs) volunteered to take part and a total of 171 patients completed and returned the questionnaire. Between a quarter and one-third of patients reported receiving less information than they desired, particularly in relation to the risks and benefits of medical treatments. Patients who preferred the doctor to make decisions for them (35%), were more likely to have their preferences met (64%) compared with patients wishing to share decisions (47%) or make their own (18%) who were less likely to achieve this role (52 and 41%, respectively). However, it could not be demonstrated unequivocally that these differences were statistically significant. In total, 61% of patients perceived that they achieved their preferred decision-making role. No significant differences were found in post-consultation enablement scores between any of the decision preference groups. Patients' assessments indicated that some doctors were more successful at achieving congruence than others. The decision-making preferences of general practice patients tend to vary. However, there was a substantial mismatch between the stated preferences of patients for the role they wanted to have in decision-making and what they felt actually took place in their consultation. Therefore, it remains a challenge for doctors to match their consultation style to the decision-making preferences of individual patients.

Validity of the neck disability index, Northwick Park neck pain questionnaire, and problem elicitation technique for measuring disability associated with whiplash-associated disorders

The Neck Disability Index (NDI) and Northwick Park Neck Pain Questionnaire (NPQ) were developed to measure self-perceived disability from neck pain, including that which may arise from whiplash injury. However, there is little data specifically concerning their validity for whiplash-associated disorders (WAD). The aim of this study was to assess the validity of the NDI and NPQ as measures of outcome in WAD by comparing them to a patient preference questionnaire, the problem elicitation technique (PET), which identifies problems that are of most importance to the individual patient. A cross-sectional study of 71 patients with varying severity and duration of WAD were recruited from a private physiotherapy practice. All patients completed a standardized self-administered questionnaire that included demographic and clinical details as well as self-perceived pain and severity of symptoms, NDI and NPQ. A trained interviewer administered the PET. Construct validity of the disability measures was examined by determining their correlation with each other and with pain and severity of symptoms by calculating Pearson's correlation coefficients. Content validity of the NDI and NPQ was assessed by comparing the items of both questionnaires to the problems identified by the PET. Participants' mean age was 40.1 years (SD=14.3) and 59 were women (83.1%). Most patients were in WAD category I ( n=23, 32.1%), or II ( n=42, 59.2%). Mean NDI, NPQ, and PET scores were 40.7 (SD=17.0), 38.7 (SD=15.8), and 160.2 (SD=92.0, range 6.0–509.5), respectively. Correlations between the NDI and PET, NPQ and PET, and NDI and NPQ were r=0.57, 0.56 and 0.88, respectively. The PET identified an average of 7.7 problems per patient (SD=4.2, range 1–17 problems). Problems most commonly identified were work for wages (52.1%), fatigued during the day (50.7%), participation in sports (47.9%), depression (43.7%), drive a car (43.7%), socialize with friends (33.8%), sleep through the night (31.0%), frustration (31.0%), and anger (28.2%). Only three of these problems are included in the NDI (work, driving, and sleeping) and only four are included in the NPQ (work, driving, sleeping, and social activities). While both the NDI and NPQ include some problems that are common in patients with WAD, frequently identified problems, such as emotional and social items are absent. In contrast to the PET, neither instrument captures the full spectrum of disabilities judged to be important by the patient.

Percutaneous Electrical Nerve Stimulation—A Novel Analgesic Therapy For Diabetic Neuropathic Pain

OBJECTIVE—To evaluate the use of percutaneous electrical nerve stimulation (PENS) in the management of patients with painful diabetic peripheral neuropathy. RESEARCH DESIGN AND METHODS—A total of 50 adult patients with type 2 diabetes and peripheral neuropathic pain openface&gt; 6 months duration involving the lower extremities were randomly assigned to receive active PENS (needles with electrical stimulation at an alternating frequency of 15 and 30 nz) and sham (needles only) treatments for 3 weeks. Each series of treatments was administered for 30 min three times a week according to a standardized protocol. After a 1‐week washout period, all patients were subsequently switched to the other modality. A 10‐cm visual analog scale (VAS) was used to assess pain, physical activity and quality of sleep before each session. The changes in VAS scores and daily requirements for oral analgesic medication were determined during each 3‐week treatment period. Patients completed the MOS 36‐Item Short‐Form Health Survey (SF‐36), the Beck Depression Inventory (BDI), and the Profile of Mood States (POMS) before and after completion of each treatment modality. At the end of the crossover study, a patient preference questionnaire was used to compare the effectiveness of the two modalities. RESULTS—Compared with the pain VAS scores before active (6.2 +/− 1.0) and sham (6.4 +/− 0.9) treatments, pain scores after treatment were reduced to 2.5 +/− 0.8 and 6.3 +/− 1.1, respectively. With active PENS treatment, the VAS activity and sleep scores were significantly improved from 5.2 +/− 1.0 and 5.8 +/− 1.3 to 7.9 +/− 1.0 and 8.3 +/− 0.7, respectively. The VAS scores for pain, activity, and sleep were unchanged from baseline values after the sham treatments. Patient's daily oral nonopioid analgesic requirements de‐creased by 49 and 14% after active and sham PENS treatments, respectively. The post‐treatment physical and mental components of the SF‐36, the BDI, and the POMS all showed a significantly greater improvement with active versus sham treatments. Active PENS treatment improved the neuropathic pain symptoms in all patients. CONCLUSIONS—PENS is a useful nonpharmacological therapeutic modality for treating diabetic neuropathic pain. In addition to decreasing extremity pain, PENS therapy improved physical activity, sense of well‐being, and quality of sleep while reducing the need for oral nonopioid analgesic medication.

Migraine Therapy: Development and Testing of a Patient Preference Questionnaire

To develop and test a patient preference questionnaire in migraine. A user-friendly, self-administered questionnaire was developed to assess the relative importance of aspects of migraine therapy to patients. It was tested in a convenience sample of 66 migraineurs. The questionnaire has five sections: patient preference, migraine history, demographics, usual behavior during an attack, and migraine impact on cognition and functionality. It employs a special reverse-ranking technique to quantify preferences. Sixty-six migraineurs participated: 86% were women, 53% had not consulted their doctor about migraine in the previous year; and only 51% took prescribed medication, the majority (52%) at the start of a migraine. "A medication that can be taken any time during a migraine attack" was ranked most important by 20% of the migraineurs, one that decreases pain from the unbearable level in 30 minutes by 17%, and one that relieves pain completely within 2 hours by 15%. Not being able to think or concentrate with severe symptoms was reported by 71%. Optional activities were impeded by migraine in 83% of subjects, but required activities in only 60%. The patient preference questionnaire is readily completed by subjects and reveals that the dimensions of relief preferred by patients can be addressed by a self-report questionnaire.